<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01687413</url>
  </required_header>
  <id_info>
    <org_study_id>201207059</org_study_id>
    <nct_id>NCT01687413</nct_id>
  </id_info>
  <brief_title>Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer</brief_title>
  <acronym>ADEPT</acronym>
  <official_title>Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Foundation for Barnes-Jewish Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies the intensity of adjuvant (&quot;helper&quot;) therapy required in p16&#xD;
      positive oropharynx cancer patients, who have had all known disease removed surgically by a&#xD;
      minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients&#xD;
      can consent to participate in either the randomized (physician chooses radiotherapy arm or&#xD;
      radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or&#xD;
      radiotherapy &amp; cisplatin arm) pathways. After the surgery, receive either radiation alone, or&#xD;
      radiation and weekly cis-platinum during therapy. Patients are then followed for cancer,&#xD;
      functional and quality of life outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual and funding issues&#xD;
  </why_stopped>
  <start_date type="Actual">January 10, 2013</start_date>
  <completion_date type="Actual">October 18, 2019</completion_date>
  <primary_completion_date type="Actual">October 18, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Disease-free Survival (DFS)</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Locoregional Control</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Distant Metastasis</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Specific Survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Complications/Acute Toxicity by Organ Class</measure>
    <time_frame>Approximately 18 weeks</time_frame>
    <description>-Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory</measure>
    <time_frame>Baseline, 1 month, 6 months, 12 months, and 24 months</time_frame>
    <description>Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5&#xD;
The lower the score the lower the quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Function as Measured by Cognitive Failures Questionnaire</measure>
    <time_frame>Baseline, 1 month, 12 months, and 24 months</time_frame>
    <description>25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering&#xD;
Answers range from 0 = never to 4 = very often&#xD;
The higher the score the worse the cognitive failures the participant has experienced</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)</measure>
    <time_frame>Baseline, 12 months, and 24 months</time_frame>
    <description>-The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from &quot;not at all&quot; to &quot;a lot&quot;. The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire</measure>
    <time_frame>Baseline, 1 month, 6 months, 12 months, and 24 months</time_frame>
    <description>It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness.&#xD;
The higher the score the worse the participant's xerostomia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hearing as Measured by Hearing Handicap Inventory - Adult</measure>
    <time_frame>Baseline, 1 month, and 12 months</time_frame>
    <description>11 item questionnaire to identify issues with hearing&#xD;
Answers are yes = 4, sometimes = 2, and no = 0&#xD;
The higher the score the more issues the participant has with hearing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity</measure>
    <time_frame>Baseline, 1 month, 6 months, and 12 months</time_frame>
    <description>1 question that asks about taste acuity&#xD;
Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity&#xD;
The higher the score the worse the participant's taste acuity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life as Measured by Speech Handicap Index</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>31 questions regarding participant's speech and the effects of speech on his/her life&#xD;
The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4&#xD;
The higher the score the worse the participant's speech is affecting his/her life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life as Measured by EORTC QLQ-C30</measure>
    <time_frame>Baseline, 1 month, 6 months, 12 months, and 24 months</time_frame>
    <description>30 questions designed to assess the quality of life of cancer patients&#xD;
The first 28 questions have answers that range from 1=not at all to 4 = very much. The higher score indicates a worse quality of life&#xD;
The last 2 questions have answers that range from 1 = very poor to 7 = excellent. The higher score indicates a better quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Oropharyngeal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiotherapy, cisplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity-modulated radiation therapy (IMRT)</intervention_name>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_label>Radiotherapy, cisplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <arm_group_label>Radiotherapy, cisplatin</arm_group_label>
    <other_name>CACP, CDDP, CPDD, DDP, Neoplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must have histologically confirmed p16 positive squamous cell carcinoma of the&#xD;
             oropharynx (OPSCC).&#xD;
&#xD;
          -  Patient must have undergone transoral resection of their T1-4a oropharynx primary to a&#xD;
             negative margin, and a neck dissection(s).&#xD;
&#xD;
          -  Patient's disease must be pathological N-stage positive.&#xD;
&#xD;
          -  Patient's disease must show extracapsular spread (ECS) in their nodal metastasis&#xD;
             verified by central pathologist's review.&#xD;
&#xD;
          -  Patients with synchronous primaries are included.&#xD;
&#xD;
          -  Patients with unknown primaries are included if the diagnosis and resection of a&#xD;
             primary site in the oropharynx is made from an endoscopic or robotic surgical&#xD;
             procedure(s).&#xD;
&#xD;
          -  Patients with recent excisional node biopsies/neck dissections are included if&#xD;
             material is evaluable for extracapsular spread.&#xD;
&#xD;
          -  Patient must be ≥ 21 years of age.&#xD;
&#xD;
          -  ECOG performance status ≤ 2 (Karnofsky ≥60%).&#xD;
&#xD;
          -  Patients must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  leukocytes ≥3,000/mcL&#xD;
&#xD;
               -  absolute neutrophil count ≥1,500/mcL&#xD;
&#xD;
               -  platelets ≥100,000/mcL&#xD;
&#xD;
               -  total bilirubin &lt;1.5 X upper normal institutional limit&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal&#xD;
&#xD;
               -  creatinine within normal institutional limits OR creatinine clearance ≥60&#xD;
                  mL/min/1.73 m2 for patients with creatinine levels above institutional normal&#xD;
&#xD;
          -  Patient (or legally authorized representative) must be able to understand and willing&#xD;
             to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient must not have pathologically N stage negative disease.&#xD;
&#xD;
          -  Patient must not have outside nodal tissue from previous neck biopsy/neck dissections&#xD;
             in which ECS cannot be confirmed or denied.&#xD;
&#xD;
          -  Patient must not have a true unknown primary in which permanent section results are&#xD;
             negative for malignancy in completely excised ipsilateral oropharyngeal tissue&#xD;
             (palatine and lingual tonsil).&#xD;
&#xD;
          -  Patient must not have distant metastatic disease at presentation.&#xD;
&#xD;
          -  Patient must not have gross residual and/or microscopic disease present after surgery&#xD;
             including re-resection(s), per the operative and pathology report.&#xD;
&#xD;
          -  Patient must not have transoral robotic surgery (TORS) for a T3 or T4 primary tumor.&#xD;
&#xD;
          -  Patient must not have a history of prior invasive malignancy (except non-melanomatous&#xD;
             skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for&#xD;
             example, carcinoma in situ of the oral cavity, larynx, breast or cervix are all&#xD;
             permissible) are permitted even if diagnosed and treated &lt; 3 years ago.&#xD;
&#xD;
          -  Patient must not have had previous systemic chemotherapy for the study cancer. (Note:&#xD;
             prior chemotherapy for a different cancer is allowable).&#xD;
&#xD;
          -  Patient must not be receiving any other investigational agents.&#xD;
&#xD;
          -  Patient must not have had any prior radiotherapy to the region of the study cancer&#xD;
             that would result in overlap of radiation therapy fields&#xD;
&#xD;
          -  Patient must not have any life-threatening comorbid illnesses e.g. stroke with major&#xD;
             sequelae or myocardial infarction/ unstable angina within the preceding 3 months or&#xD;
             psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements.&#xD;
&#xD;
          -  Patient must not be pregnant or breastfeeding. If a woman of childbearing potential,&#xD;
             patient must agree to use medically acceptable forms of contraception.&#xD;
&#xD;
        Both men and women and members of all races and ethnic groups are eligible for this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Rich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic Scottsdale</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259-5499</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>October 16, 2020</results_first_submitted>
  <results_first_submitted_qc>October 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 10, 2020</results_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT01687413/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Radiotherapy</title>
          <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
        </group>
        <group group_id="P2">
          <title>Radiotherapy, Cisplatin</title>
          <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not eligible</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient withdrew before completing all radiotherapy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Radiotherapy</title>
          <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
        </group>
        <group group_id="B2">
          <title>Radiotherapy, Cisplatin</title>
          <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56" lower_limit="41" upper_limit="74"/>
                    <measurement group_id="B2" value="55" lower_limit="32" upper_limit="74"/>
                    <measurement group_id="B3" value="56" lower_limit="32" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Disease-free Survival (DFS)</title>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Radiotherapy, Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Disease-free Survival (DFS)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Locoregional Control</title>
        <description>Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.</description>
        <time_frame>Up to 2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Radiotherapy, Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Locoregional Control</title>
          <description>Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Distant Metastasis</title>
        <description>Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.</description>
        <time_frame>Up to 2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Radiotherapy, Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Distant Metastasis</title>
          <description>Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Specific Survival</title>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Radiotherapy, Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Specific Survival</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Complications/Acute Toxicity by Organ Class</title>
        <description>-Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.</description>
        <time_frame>Approximately 18 weeks</time_frame>
        <population>One participant in each Arm did not have adverse events collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Radiotherapy, Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Complications/Acute Toxicity by Organ Class</title>
          <description>-Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.</description>
          <population>One participant in each Arm did not have adverse events collected.</population>
          <units>number of adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blood and lymphatic system disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ear and labyrinth disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eye disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immune system disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infections and infestations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injury, poisoning and procedureal complications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Investigations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolism and nutrition disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Musculoskeletal and connective tissue disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nervous system disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychiatric disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory, thoracic and mediastinal disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin and subcutaneous tissue disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surgical and medical procedures</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vascular disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory</title>
        <description>Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5&#xD;
The lower the score the lower the quality of life</description>
        <time_frame>Baseline, 1 month, 6 months, 12 months, and 24 months</time_frame>
        <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Baseline - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O3">
            <title>1 Month - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O4">
            <title>1 Month - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O5">
            <title>6 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O6">
            <title>6 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O7">
            <title>12 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O8">
            <title>12 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O9">
            <title>24 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O10">
            <title>24 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory</title>
          <description>Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5&#xD;
The lower the score the lower the quality of life</description>
          <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="13"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="15"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="17"/>
                <count group_id="O10" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>My swallowing ability limits my day to day activities.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2608696" spread="1.3888318"/>
                    <measurement group_id="O2" value="4.0000000" spread="1.0954451"/>
                    <measurement group_id="O3" value="4.1818182" spread="1.2203186"/>
                    <measurement group_id="O4" value="4.1818182" spread="1.1677484"/>
                    <measurement group_id="O5" value="4.3076923" spread="0.9473309"/>
                    <measurement group_id="O6" value="3.5714286" spread="1.5118579"/>
                    <measurement group_id="O7" value="4.5000000" spread="0.6504436"/>
                    <measurement group_id="O8" value="3.2857143" spread="1.6035675"/>
                    <measurement group_id="O9" value="3.9375000" spread="1.3889444"/>
                    <measurement group_id="O10" value="4.6250000" spread="0.5175492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I am embarrassed by my eating habits.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5454545" spread="1.2993505"/>
                    <measurement group_id="O2" value="4.4545455" spread="0.8201995"/>
                    <measurement group_id="O3" value="4.1818182" spread="1.2587357"/>
                    <measurement group_id="O4" value="4.4545455" spread="0.5222330"/>
                    <measurement group_id="O5" value="4.3846154" spread="1.1208971"/>
                    <measurement group_id="O6" value="3.8571429" spread="0.6900656"/>
                    <measurement group_id="O7" value="4.4285714" spread="0.7559289"/>
                    <measurement group_id="O8" value="3.1428571" spread="1.2149858"/>
                    <measurement group_id="O9" value="4.1250000" spread="1.2041595"/>
                    <measurement group_id="O10" value="4.1250000" spread="0.6408699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swallowing is more difficult at the end of the day.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3636364" spread="1.4974726"/>
                    <measurement group_id="O2" value="4.5454545" spread="0.6875517"/>
                    <measurement group_id="O3" value="3.8095238" spread="1.3273676"/>
                    <measurement group_id="O4" value="4.0909091" spread="0.9438798"/>
                    <measurement group_id="O5" value="4.6153846" spread="0.8697185"/>
                    <measurement group_id="O6" value="3.8571429" spread="1.0690450"/>
                    <measurement group_id="O7" value="4.2857143" spread="1.1387288"/>
                    <measurement group_id="O8" value="4.1428571" spread="1.0690450"/>
                    <measurement group_id="O9" value="4.4000000" spread="0.9102590"/>
                    <measurement group_id="O10" value="4.7500000" spread="0.4629100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I do not feel self-conscious when I eat.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3913043" spread="1.3395769"/>
                    <measurement group_id="O2" value="4.0909091" spread="1.2210279"/>
                    <measurement group_id="O3" value="3.9090909" spread="1.1087999"/>
                    <measurement group_id="O4" value="4.1818182" spread="0.9816498"/>
                    <measurement group_id="O5" value="4.3846154" spread="0.9607689"/>
                    <measurement group_id="O6" value="3.7142857" spread="1.1126973"/>
                    <measurement group_id="O7" value="4.0769231" spread="1.3204506"/>
                    <measurement group_id="O8" value="3.7142857" spread="1.2535663"/>
                    <measurement group_id="O9" value="3.6875000" spread="1.3022417"/>
                    <measurement group_id="O10" value="4.5000000" spread="0.7559289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I am upset by my swallowing problem.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2272727" spread="1.6599431"/>
                    <measurement group_id="O2" value="2.0909091" spread="1.5135749"/>
                    <measurement group_id="O3" value="2.8636364" spread="1.6123173"/>
                    <measurement group_id="O4" value="2.6363636" spread="1.3618170"/>
                    <measurement group_id="O5" value="3.1538462" spread="1.6756170"/>
                    <measurement group_id="O6" value="2.2857143" spread="1.2535663"/>
                    <measurement group_id="O7" value="2.7857143" spread="1.6723347"/>
                    <measurement group_id="O8" value="3.1428571" spread="1.3451854"/>
                    <measurement group_id="O9" value="3.0625000" spread="1.7308476"/>
                    <measurement group_id="O10" value="3.2500000" spread="1.4880476"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>People have difficulty cooking for me.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2173913" spread="1.5062452"/>
                    <measurement group_id="O2" value="3.9090909" spread="1.2210279"/>
                    <measurement group_id="O3" value="3.7727273" spread="1.3777766"/>
                    <measurement group_id="O4" value="4.2727273" spread="1.0090500"/>
                    <measurement group_id="O5" value="3.7692308" spread="1.4806444"/>
                    <measurement group_id="O6" value="3.1428571" spread="1.2149858"/>
                    <measurement group_id="O7" value="4.2142857" spread="1.1883131"/>
                    <measurement group_id="O8" value="3.7142857" spread="1.3801311"/>
                    <measurement group_id="O9" value="3.9375000" spread="1.3400871"/>
                    <measurement group_id="O10" value="4.1250000" spread="0.6408699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swallowing takes great effort.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0869565" spread="1.5049326"/>
                    <measurement group_id="O2" value="3.4545455" spread="1.2135598"/>
                    <measurement group_id="O3" value="3.9545455" spread="1.0455016"/>
                    <measurement group_id="O4" value="3.9090909" spread="1.2210279"/>
                    <measurement group_id="O5" value="3.6923077" spread="1.3155870"/>
                    <measurement group_id="O6" value="3.0000000" spread="1.1547005"/>
                    <measurement group_id="O7" value="3.9285714" spread="1.3847680"/>
                    <measurement group_id="O8" value="3.1428571" spread="1.5735916"/>
                    <measurement group_id="O9" value="3.5625000" spread="1.2632630"/>
                    <measurement group_id="O10" value="3.3750000" spread="1.4078860"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I do not go out because of my swallowing problem.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9130435" spread="0.9960396"/>
                    <measurement group_id="O2" value="4.6363636" spread="0.5045250"/>
                    <measurement group_id="O3" value="4.3181818" spread="0.9454837"/>
                    <measurement group_id="O4" value="4.1818182" spread="0.9816498"/>
                    <measurement group_id="O5" value="4.5384615" spread="0.8770580"/>
                    <measurement group_id="O6" value="3.8571429" spread="1.0690450"/>
                    <measurement group_id="O7" value="4.6428571" spread="0.6333237"/>
                    <measurement group_id="O8" value="4.1428571" spread="1.0690450"/>
                    <measurement group_id="O9" value="4.1875000" spread="1.0468206"/>
                    <measurement group_id="O10" value="4.2500000" spread="0.8864053"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My swallowing difficulty has caused me to lose income.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2608696" spread="1.0538842"/>
                    <measurement group_id="O2" value="3.9090909" spread="1.7002674"/>
                    <measurement group_id="O3" value="4.5000000" spread="0.7400129"/>
                    <measurement group_id="O4" value="4.3636364" spread="0.8090398"/>
                    <measurement group_id="O5" value="4.6153846" spread="0.6504436"/>
                    <measurement group_id="O6" value="4.0000000" spread="1.1547005"/>
                    <measurement group_id="O7" value="4.6428571" spread="0.6333237"/>
                    <measurement group_id="O8" value="3.8571429" spread="1.2149858"/>
                    <measurement group_id="O9" value="4.6000000" spread="0.6324555"/>
                    <measurement group_id="O10" value="4.5000000" spread="0.7559289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>It takes me longer to eat because of my swallowing problem.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5909091" spread="1.4690162"/>
                    <measurement group_id="O2" value="2.4000000" spread="1.4298407"/>
                    <measurement group_id="O3" value="3.1818182" spread="1.5625487"/>
                    <measurement group_id="O4" value="2.9090909" spread="1.7002674"/>
                    <measurement group_id="O5" value="3.0769231" spread="1.4978617"/>
                    <measurement group_id="O6" value="2.1428571" spread="0.8997354"/>
                    <measurement group_id="O7" value="3.5000000" spread="1.6052798"/>
                    <measurement group_id="O8" value="3.0000000" spread="1.9148542"/>
                    <measurement group_id="O9" value="2.8750000" spread="1.5438048"/>
                    <measurement group_id="O10" value="3.1250000" spread="1.6420806"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>People ask me, &quot;Why can't you eat that?&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0869565" spread="1.1246431"/>
                    <measurement group_id="O2" value="4.0000000" spread="1.1547005"/>
                    <measurement group_id="O3" value="4.0000000" spread="1.2344268"/>
                    <measurement group_id="O4" value="3.7272727" spread="1.3483997"/>
                    <measurement group_id="O5" value="4.1538462" spread="1.2810252"/>
                    <measurement group_id="O6" value="3.4285714" spread="1.1338934"/>
                    <measurement group_id="O7" value="4.2142857" spread="1.1883131"/>
                    <measurement group_id="O8" value="3.0000000" spread="1.6329932"/>
                    <measurement group_id="O9" value="4.1875000" spread="1.3275918"/>
                    <measurement group_id="O10" value="4.5000000" spread="0.9258201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other people are irritated by my eating problem.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2608696" spread="0.8643122"/>
                    <measurement group_id="O2" value="4.2727273" spread="1.0090500"/>
                    <measurement group_id="O3" value="4.5454545" spread="0.7385489"/>
                    <measurement group_id="O4" value="4.3636364" spread="0.8090398"/>
                    <measurement group_id="O5" value="4.6923077" spread="0.6304252"/>
                    <measurement group_id="O6" value="3.8571429" spread="0.6900656"/>
                    <measurement group_id="O7" value="4.5714286" spread="0.7559289"/>
                    <measurement group_id="O8" value="4.1428571" spread="0.8997354"/>
                    <measurement group_id="O9" value="4.3750000" spread="0.8062258"/>
                    <measurement group_id="O10" value="4.3750000" spread="0.9161254"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cognitive Function as Measured by Cognitive Failures Questionnaire</title>
        <description>25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering&#xD;
Answers range from 0 = never to 4 = very often&#xD;
The higher the score the worse the cognitive failures the participant has experienced</description>
        <time_frame>Baseline, 1 month, 12 months, and 24 months</time_frame>
        <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Baseline - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O3">
            <title>1 Month - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O4">
            <title>1 Month - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O5">
            <title>12 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O6">
            <title>12 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O7">
            <title>24 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O8">
            <title>24 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cognitive Function as Measured by Cognitive Failures Questionnaire</title>
          <description>25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering&#xD;
Answers range from 0 = never to 4 = very often&#xD;
The higher the score the worse the cognitive failures the participant has experienced</description>
          <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="17"/>
                <count group_id="O8" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Do you read something and find you haven't been thinking about it and must read it again?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4166667" spread="0.9743076"/>
                    <measurement group_id="O2" value="1.3636364" spread="1.2060454"/>
                    <measurement group_id="O3" value="1.5454545" spread="1.0107646"/>
                    <measurement group_id="O4" value="1.2727273" spread="0.7862454"/>
                    <measurement group_id="O5" value="1.4666667" spread="0.9154754"/>
                    <measurement group_id="O6" value="2.1666667" spread="1.1690452"/>
                    <measurement group_id="O7" value="1.5625000" spread="0.7274384"/>
                    <measurement group_id="O8" value="1.5714286" spread="1.1338934"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find you forget why you went from one part of the house to the other?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2083333" spread="0.9770927"/>
                    <measurement group_id="O2" value="1.0909091" spread="0.9438798"/>
                    <measurement group_id="O3" value="1.2727273" spread="1.1621744"/>
                    <measurement group_id="O4" value="1.0000000" spread="1.0000000"/>
                    <measurement group_id="O5" value="1.333333" spread="1.3451854"/>
                    <measurement group_id="O6" value="1.5000000" spread="0.8366600"/>
                    <measurement group_id="O7" value="1.4375000" spread="0.8920949"/>
                    <measurement group_id="O8" value="1.4285714" spread="1.2724180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you fail to notice signposts on the road?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6666667" spread="0.9168313"/>
                    <measurement group_id="O2" value="0.3636364" spread="0.6741999"/>
                    <measurement group_id="O3" value="0.7272727" spread="0.9847319"/>
                    <measurement group_id="O4" value="0.5454545" spread="0.6875517"/>
                    <measurement group_id="O5" value="0.6666667" spread="0.6172134"/>
                    <measurement group_id="O6" value="0.8333333" spread="0.7527727"/>
                    <measurement group_id="O7" value="0.6250000" spread="0.6191392"/>
                    <measurement group_id="O8" value="0.8571429" spread="1.0690450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find you confuse right and left when giving directions?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3333333" spread="0.8681147"/>
                    <measurement group_id="O2" value="0.2727273" spread="0.4670994"/>
                    <measurement group_id="O3" value="0.4545455" spread="0.9116846"/>
                    <measurement group_id="O4" value="0.2727273" spread="0.6466698"/>
                    <measurement group_id="O5" value="0.2666667" spread="0.5936168"/>
                    <measurement group_id="O6" value="0.3333333" spread="0.5163978"/>
                    <measurement group_id="O7" value="0.3750000" spread="0.6191392"/>
                    <measurement group_id="O8" value="0.5714286" spread="0.7867958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you bump into people?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2500000" spread="0.5316095"/>
                    <measurement group_id="O2" value="0.1818182" spread="0.4045199"/>
                    <measurement group_id="O3" value="0.3636364" spread="0.6579517"/>
                    <measurement group_id="O4" value="0.1818182" spread="0.6030227"/>
                    <measurement group_id="O5" value="0.4666667" spread="0.7432234"/>
                    <measurement group_id="O6" value="0.8333333" spread="1.3291601"/>
                    <measurement group_id="O7" value="0.3125000" spread="0.4787136"/>
                    <measurement group_id="O8" value="0.5714286" spread="0.9759001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find you forget whether you've turned off a light or a fire or locked the door?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9583333" spread="0.9990938"/>
                    <measurement group_id="O2" value="0.6363636" spread="0.6741999"/>
                    <measurement group_id="O3" value="0.8636364" spread="1.1252705"/>
                    <measurement group_id="O4" value="0.6363636" spread="0.6741999"/>
                    <measurement group_id="O5" value="1.1333333" spread="1.0600988"/>
                    <measurement group_id="O6" value="1.3333333" spread="0.5163978"/>
                    <measurement group_id="O7" value="0.7333333" spread="0.7037316"/>
                    <measurement group_id="O8" value="1.2857143" spread="0.9511897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you fail to listen to people's names when you are meeting them?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7083333" spread="1.3014763"/>
                    <measurement group_id="O2" value="1.0909091" spread="1.3003496"/>
                    <measurement group_id="O3" value="1.8181818" spread="1.0970247"/>
                    <measurement group_id="O4" value="1.0909091" spread="1.0444659"/>
                    <measurement group_id="O5" value="2.0000000" spread="1.1952286"/>
                    <measurement group_id="O6" value="1.3333333" spread="1.0327959"/>
                    <measurement group_id="O7" value="1.6250000" spread="1.0246951"/>
                    <measurement group_id="O8" value="1.4285714" spread="1.2724180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you say something and realize afterwards that it might be taken as insulting?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0000000" spread="1.0632191"/>
                    <measurement group_id="O2" value="0.9090909" spread="0.8312094"/>
                    <measurement group_id="O3" value="1.0000000" spread="1.1126973"/>
                    <measurement group_id="O4" value="0.8181818" spread="0.6030227"/>
                    <measurement group_id="O5" value="1.0666667" spread="0.7988086"/>
                    <measurement group_id="O6" value="1.0000000" spread="0.6324555"/>
                    <measurement group_id="O7" value="1.2500000" spread="1.0000000"/>
                    <measurement group_id="O8" value="0.8571429" spread="1.4638501"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you fail to hear people speaking to you when you are doing something else?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3750000" spread="1.3772215"/>
                    <measurement group_id="O2" value="1.2727273" spread="1.2720778"/>
                    <measurement group_id="O3" value="1.4090909" spread="1.0980108"/>
                    <measurement group_id="O4" value="1.0909091" spread="0.7006490"/>
                    <measurement group_id="O5" value="1.4000000" spread="0.9102590"/>
                    <measurement group_id="O6" value="1.8333333" spread="0.9831921"/>
                    <measurement group_id="O7" value="1.4375000" spread="1.0307764"/>
                    <measurement group_id="O8" value="1.5714286" spread="0.9759001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you lose your temper and regret it?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9583333" spread="1.0417029"/>
                    <measurement group_id="O2" value="1.0000000" spread="0.7745967"/>
                    <measurement group_id="O3" value="1.0909091" spread="1.0649879"/>
                    <measurement group_id="O4" value="0.8181818" spread="0.6030227"/>
                    <measurement group_id="O5" value="0.8666667" spread="0.8338094"/>
                    <measurement group_id="O6" value="0.8333333" spread="0.7527727"/>
                    <measurement group_id="O7" value="0.8125000" spread="0.7500000"/>
                    <measurement group_id="O8" value="1.4285714" spread="1.2724180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you leave important letters unanswered for days?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6666667" spread="1.0772203"/>
                    <measurement group_id="O2" value="0.6363636" spread="1.0269106"/>
                    <measurement group_id="O3" value="1.0000000" spread="1.0235326"/>
                    <measurement group_id="O4" value="0.4545455" spread="0.9341987"/>
                    <measurement group_id="O5" value="0.7857143" spread="0.9749613"/>
                    <measurement group_id="O6" value="0.8333333" spread="0.7527727"/>
                    <measurement group_id="O7" value="0.8125000" spread="0.7500000"/>
                    <measurement group_id="O8" value="1.0000000" spread="1.1547005"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find you forget which way to turn on a road you know well but rarely use?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4782609" spread="0.9472239"/>
                    <measurement group_id="O2" value="0.4545455" spread="0.8201995"/>
                    <measurement group_id="O3" value="0.4090909" spread="0.9591212"/>
                    <measurement group_id="O4" value="0.5454545" spread="0.9341987"/>
                    <measurement group_id="O5" value="0.3333333" spread="0.6172134"/>
                    <measurement group_id="O6" value="0.5000000" spread="0.8366600"/>
                    <measurement group_id="O7" value="0.3125000" spread="0.4787136"/>
                    <measurement group_id="O8" value="0.2857143" spread="0.4879500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you fail to see what you want in a supermarket (although it's there)?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6250000" spread="0.7696696"/>
                    <measurement group_id="O2" value="0.4545455" spread="0.5222330"/>
                    <measurement group_id="O3" value="0.9090909" spread="1.0649879"/>
                    <measurement group_id="O4" value="0.5454545" spread="0.6875517"/>
                    <measurement group_id="O5" value="1.0666667" spread="1.0997835"/>
                    <measurement group_id="O6" value="1.0000000" spread="0.6324555"/>
                    <measurement group_id="O7" value="0.8750000" spread="0.7187953"/>
                    <measurement group_id="O8" value="0.7142857" spread="0.4879500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find yourself suddenly wondering whether you've used a word correctly?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5833333" spread="0.7172815"/>
                    <measurement group_id="O2" value="0.6363636" spread="0.6741999"/>
                    <measurement group_id="O3" value="0.7727273" spread="1.0203556"/>
                    <measurement group_id="O4" value="0.6363636" spread="0.8090398"/>
                    <measurement group_id="O5" value="0.8000000" spread="0.8618916"/>
                    <measurement group_id="O6" value="0.6666667" spread="1.2110601"/>
                    <measurement group_id="O7" value="0.7500000" spread="0.6831301"/>
                    <measurement group_id="O8" value="0.8571429" spread="0.8997354"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you have trouble making up your mind?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9583333" spread="1.0826363"/>
                    <measurement group_id="O2" value="0.9090909" spread="1.0444659"/>
                    <measurement group_id="O3" value="1.0000000" spread="1.1126973"/>
                    <measurement group_id="O4" value="0.9090909" spread="0.9438798"/>
                    <measurement group_id="O5" value="0.9333333" spread="0.9611501"/>
                    <measurement group_id="O6" value="1.0000000" spread="1.0954451"/>
                    <measurement group_id="O7" value="1.0625000" spread="0.9287088"/>
                    <measurement group_id="O8" value="1.1428571" spread="1.2149858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find you forget appointments?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5833333" spread="0.9743076"/>
                    <measurement group_id="O2" value="0.5454545" spread="0.6875517"/>
                    <measurement group_id="O3" value="0.7727273" spread="1.1097755"/>
                    <measurement group_id="O4" value="0.6363636" spread="0.6741999"/>
                    <measurement group_id="O5" value="0.5333333" spread="0.8338094"/>
                    <measurement group_id="O6" value="0.8333333" spread="0.7527727"/>
                    <measurement group_id="O7" value="0.6250000" spread="0.6191392"/>
                    <measurement group_id="O8" value="1.0000000" spread="1.1547005"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you forget where you put something like a newspaper or a book?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0416667" spread="0.8064504"/>
                    <measurement group_id="O2" value="1.00000000" spread="0.8944272"/>
                    <measurement group_id="O3" value="1.1363636" spread="1.0371873"/>
                    <measurement group_id="O4" value="0.8181818" spread="0.7507572"/>
                    <measurement group_id="O5" value="1.4000000" spread="0.9102590"/>
                    <measurement group_id="O6" value="1.3333333" spread="0.5163978"/>
                    <measurement group_id="O7" value="1.1250000" spread="0.7187953"/>
                    <measurement group_id="O8" value="1.5714286" spread="1.3972763"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find you accidentally throw away the thing you want and keep what you meant to throw away?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5416667" spread="1.0623668"/>
                    <measurement group_id="O2" value="0.1818182" spread="0.4045199"/>
                    <measurement group_id="O3" value="0.5454545" spread="1.0107646"/>
                    <measurement group_id="O4" value="0.1818182" spread="0.6030227"/>
                    <measurement group_id="O5" value="0.6666667" spread="0.7237469"/>
                    <measurement group_id="O6" value="0.3333333" spread="0.5163978"/>
                    <measurement group_id="O7" value="0.6250000" spread="0.7187953"/>
                    <measurement group_id="O8" value="0.5714286" spread="0.7867958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you daydream when you out to be listening to something?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1250000" spread="1.0347232"/>
                    <measurement group_id="O2" value="1.2727273" spread="1.0090500"/>
                    <measurement group_id="O3" value="1.1818182" spread="1.0064726"/>
                    <measurement group_id="O4" value="0.9090909" spread="0.8312094"/>
                    <measurement group_id="O5" value="1.0000000" spread="0.9258201"/>
                    <measurement group_id="O6" value="0.8333333" spread="1.1690452"/>
                    <measurement group_id="O7" value="1.0000000" spread="0.7302967"/>
                    <measurement group_id="O8" value="0.8571429" spread="1.0690450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find you forget people's names?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8333333" spread="1.1671842"/>
                    <measurement group_id="O2" value="1.6363636" spread="1.5015144"/>
                    <measurement group_id="O3" value="1.8636364" spread="1.3556040"/>
                    <measurement group_id="O4" value="1.6363636" spread="1.1200649"/>
                    <measurement group_id="O5" value="2.0666667" spread="1.3345233"/>
                    <measurement group_id="O6" value="1.6666667" spread="1.0327956"/>
                    <measurement group_id="O7" value="1.8125000" spread="0.9105859"/>
                    <measurement group_id="O8" value="1.8571429" spread="1.3451854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you start doing one thing at home and get distracted into doing something else (unintentionally)?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2500000" spread="1.1887151"/>
                    <measurement group_id="O2" value="1.0909091" spread="1.0444659"/>
                    <measurement group_id="O3" value="1.5454545" spread="1.1843131"/>
                    <measurement group_id="O4" value="1.0000000" spread="0.7745967"/>
                    <measurement group_id="O5" value="1.3333333" spread="1.1126973"/>
                    <measurement group_id="O6" value="2.3333333" spread="1.2110601"/>
                    <measurement group_id="O7" value="1.3125000" spread="0.9464847"/>
                    <measurement group_id="O8" value="1.4285714" spread="1.5118579"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find you can't quite remember something although it's on the tip of your tongue?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4166667" spread="0.9743076"/>
                    <measurement group_id="O2" value="1.4545455" spread="1.2135598"/>
                    <measurement group_id="O3" value="1.8181818" spread="0.8528029"/>
                    <measurement group_id="O4" value="1.2727273" spread="0.9045340"/>
                    <measurement group_id="O5" value="1.7333333" spread="1.0327956"/>
                    <measurement group_id="O6" value="2.0000000" spread="0.6324555"/>
                    <measurement group_id="O7" value="1.6250000" spread="0.6191392"/>
                    <measurement group_id="O8" value="1.5714286" spread="1.3972763"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find you forget what you came to the shops to buy?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8333333" spread="0.8164966"/>
                    <measurement group_id="O2" value="0.6363636" spread="0.8090398"/>
                    <measurement group_id="O3" value="1.1363636" spread="0.9902118"/>
                    <measurement group_id="O4" value="0.3636364" spread="0.6741999"/>
                    <measurement group_id="O5" value="1.2666667" spread="1.3345233"/>
                    <measurement group_id="O6" value="1.1666667" spread="0.9831921"/>
                    <measurement group_id="O7" value="0.7500000" spread="0.8563488"/>
                    <measurement group_id="O8" value="0.7142857" spread="0.4879500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you drop things?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4583333" spread="0.7790276"/>
                    <measurement group_id="O2" value="0.8181818" spread="0.6030227"/>
                    <measurement group_id="O3" value="0.8181818" spread="1.0527227"/>
                    <measurement group_id="O4" value="0.6363636" spread="0.6741999"/>
                    <measurement group_id="O5" value="0.6666667" spread="0.6172134"/>
                    <measurement group_id="O6" value="1.3333333" spread="1.0327956"/>
                    <measurement group_id="O7" value="1.0000000" spread="0.8944272"/>
                    <measurement group_id="O8" value="0.8571429" spread="0.6900656"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you find you can't think of anything to say?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7916667" spread="0.9315329"/>
                    <measurement group_id="O2" value="0.5454545" spread="0.6875517"/>
                    <measurement group_id="O3" value="0.8636364" spread="1.1252705"/>
                    <measurement group_id="O4" value="0.9090909" spread="0.7006490"/>
                    <measurement group_id="O5" value="0.8000000" spread="0.8618916"/>
                    <measurement group_id="O6" value="1.1666667" spread="0.7527727"/>
                    <measurement group_id="O7" value="1.0000000" spread="0.9660918"/>
                    <measurement group_id="O8" value="1.0000000" spread="1.0000000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)</title>
        <description>-The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from &quot;not at all&quot; to &quot;a lot&quot;. The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot).</description>
        <time_frame>Baseline, 12 months, and 24 months</time_frame>
        <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Baseline - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O3">
            <title>12 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O4">
            <title>12 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O5">
            <title>24 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O6">
            <title>24 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)</title>
          <description>-The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from &quot;not at all&quot; to &quot;a lot&quot;. The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot).</description>
          <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="17"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Neck or shoulder pain or discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6086957" spread="1.1175920"/>
                    <measurement group_id="O2" value="2.0909091" spread="1.2210279"/>
                    <measurement group_id="O3" value="1.4666667" spread="0.9904304"/>
                    <measurement group_id="O4" value="2.4285714" spread="1.5118579"/>
                    <measurement group_id="O5" value="1.3125000" spread="0.8732125"/>
                    <measurement group_id="O6" value="1.7500000" spread="1.2817399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neck or shoulder stiffness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4545455" spread="1.1433981"/>
                    <measurement group_id="O2" value="2.0000000" spread="1.2649111"/>
                    <measurement group_id="O3" value="1.0000000" spread="0.8451543"/>
                    <measurement group_id="O4" value="2.4285714" spread="1.5118579"/>
                    <measurement group_id="O5" value="1.1875000" spread="1.0468206"/>
                    <measurement group_id="O6" value="1.7500000" spread="1.3887301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficulty with self-care activities because of neck or shoulder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8695652" spread="0.9197009"/>
                    <measurement group_id="O2" value="1.2727273" spread="1.1037127"/>
                    <measurement group_id="O3" value="0.3333333" spread="0.8164966"/>
                    <measurement group_id="O4" value="1.0000000" spread="1.0000000"/>
                    <measurement group_id="O5" value="0.2500000" spread="0.5773503"/>
                    <measurement group_id="O6" value="0.5000000" spread="1.4142136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limited ability to life light objects because of your shoulder or neck</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6521739" spread="0.8846517"/>
                    <measurement group_id="O2" value="1.6363636" spread="1.4333686"/>
                    <measurement group_id="O3" value="0.4000000" spread="0.7367884"/>
                    <measurement group_id="O4" value="0.8571429" spread="1.0690450"/>
                    <measurement group_id="O5" value="0.2500000" spread="0.5773503"/>
                    <measurement group_id="O6" value="0.5000000" spread="0.7559289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limited ability to lift heavy objects because of your shoulder or neck</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6086957" spread="1.3395769"/>
                    <measurement group_id="O2" value="2.2727273" spread="1.4206273"/>
                    <measurement group_id="O3" value="0.5333333" spread="0.9904304"/>
                    <measurement group_id="O4" value="1.5714286" spread="1.7182494"/>
                    <measurement group_id="O5" value="0.4666667" spread="0.8338094"/>
                    <measurement group_id="O6" value="0.8750000" spread="0.9910312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limited ability to reach for objects because of your shoulder or neck</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2173913" spread="1.3802675"/>
                    <measurement group_id="O2" value="2.0909091" spread="1.5135749"/>
                    <measurement group_id="O3" value="0.5333333" spread="0.8338094"/>
                    <measurement group_id="O4" value="1.7142857" spread="1.6035675"/>
                    <measurement group_id="O5" value="0.5625000" spread="0.9639329"/>
                    <measurement group_id="O6" value="0.7500000" spread="1.0350983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall activity level because of your shoulder or neck</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0000000" spread="1.2431631"/>
                    <measurement group_id="O2" value="1.9090909" spread="1.5782614"/>
                    <measurement group_id="O3" value="0.5333333" spread="0.8338094"/>
                    <measurement group_id="O4" value="1.5714286" spread="1.5118579"/>
                    <measurement group_id="O5" value="0.3750000" spread="0.6191392"/>
                    <measurement group_id="O6" value="0.6250000" spread="0.7440238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Has the treatment of your neck affected your participation in social activities?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7391304" spread="1.1368774"/>
                    <measurement group_id="O2" value="0.9090909" spread="1.2210279"/>
                    <measurement group_id="O3" value="0.0666667" spread="0.2581989"/>
                    <measurement group_id="O4" value="0.8571429" spread="0.8997354"/>
                    <measurement group_id="O5" value="0.1875000" spread="0.4031129"/>
                    <measurement group_id="O6" value="0.5000000" spread="1.0690450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limited in ability to do leisure or recreational activities because of your neck or shoulder?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0869565" spread="1.3788349"/>
                    <measurement group_id="O2" value="1.7272727" spread="1.4893562"/>
                    <measurement group_id="O3" value="0.2000000" spread="0.5606119"/>
                    <measurement group_id="O4" value="1.4285714" spread="1.2724180"/>
                    <measurement group_id="O5" value="0.2500000" spread="0.4472136"/>
                    <measurement group_id="O6" value="0.7500000" spread="1.1649647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limited in ability to do work including work at home because of neck or shoulder discomfort or pain?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1304348" spread="1.3916749"/>
                    <measurement group_id="O2" value="1.7272727" spread="1.6180797"/>
                    <measurement group_id="O3" value="0.2666667" spread="0.5936168"/>
                    <measurement group_id="O4" value="1.2857143" spread="1.1126973"/>
                    <measurement group_id="O5" value="0.1250000" spread="0.3415650"/>
                    <measurement group_id="O6" value="0.5000000" spread="1.0690450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire</title>
        <description>It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness.&#xD;
The higher the score the worse the participant's xerostomia</description>
        <time_frame>Baseline, 1 month, 6 months, 12 months, and 24 months</time_frame>
        <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Baseline - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O3">
            <title>1 Month - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O4">
            <title>1 Month - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O5">
            <title>6 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O6">
            <title>6 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O7">
            <title>12 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O8">
            <title>12 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O9">
            <title>24 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O10">
            <title>24 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire</title>
          <description>It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness.&#xD;
The higher the score the worse the participant's xerostomia</description>
          <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="17"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="17"/>
                <count group_id="O10" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Rate your difficulty in talking due to dryness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3333333" spread="2.4788964"/>
                    <measurement group_id="O2" value="1.3636364" spread="2.2033033"/>
                    <measurement group_id="O3" value="2.8095238" spread="2.9089353"/>
                    <measurement group_id="O4" value="3.9090909" spread="2.3855626"/>
                    <measurement group_id="O5" value="3.0000000" spread="2.9612887"/>
                    <measurement group_id="O6" value="4.8571429" spread="3.2366944"/>
                    <measurement group_id="O7" value="2.5625000" spread="2.8276905"/>
                    <measurement group_id="O8" value="3.5714286" spread="3.2071349"/>
                    <measurement group_id="O9" value="3.6875000" spread="2.9825884"/>
                    <measurement group_id="O10" value="3.1250000" spread="2.7998724"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate your difficulty chewing due to dryness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3913043" spread="2.2711457"/>
                    <measurement group_id="O2" value="1.4545455" spread="2.5831623"/>
                    <measurement group_id="O3" value="3.5238095" spread="2.6947922"/>
                    <measurement group_id="O4" value="3.1818182" spread="2.8219916"/>
                    <measurement group_id="O5" value="3.0714286" spread="2.4326082"/>
                    <measurement group_id="O6" value="4.5714286" spread="3.5523299"/>
                    <measurement group_id="O7" value="2.6250000" spread="2.2766935"/>
                    <measurement group_id="O8" value="3.7142857" spread="3.8606686"/>
                    <measurement group_id="O9" value="3.6250000" spread="2.9183329"/>
                    <measurement group_id="O10" value="2.7500000" spread="2.6592158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate your difficulty in swallowing solid food due to dryness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6956522" spread="2.6532104"/>
                    <measurement group_id="O2" value="1.6363636" spread="2.8380531"/>
                    <measurement group_id="O3" value="3.4285714" spread="2.5994505"/>
                    <measurement group_id="O4" value="3.9000000" spread="2.9608557"/>
                    <measurement group_id="O5" value="3.5000000" spread="2.9807072"/>
                    <measurement group_id="O6" value="5.2857143" spread="3.5456210"/>
                    <measurement group_id="O7" value="3.3750000" spread="3.0304015"/>
                    <measurement group_id="O8" value="4.1428571" spread="3.5321651"/>
                    <measurement group_id="O9" value="4.1250000" spread="2.8722813"/>
                    <measurement group_id="O10" value="3.2500000" spread="3.0118812"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate the frequency of your sleeping problems due to dryness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7916667" spread="1.8876985"/>
                    <measurement group_id="O2" value="1.5454545" spread="2.8412545"/>
                    <measurement group_id="O3" value="3.2857143" spread="2.9179249"/>
                    <measurement group_id="O4" value="3.0000000" spread="2.8982753"/>
                    <measurement group_id="O5" value="1.7142857" spread="2.0542104"/>
                    <measurement group_id="O6" value="4.4285714" spread="2.8199966"/>
                    <measurement group_id="O7" value="2.2500000" spread="2.2656861"/>
                    <measurement group_id="O8" value="3.5714286" spread="3.1014590"/>
                    <measurement group_id="O9" value="2.6000000" spread="2.8485585"/>
                    <measurement group_id="O10" value="2.7500000" spread="2.4348658"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate your mouth or throat dryness when eating food</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2173913" spread="2.1523037"/>
                    <measurement group_id="O2" value="1.8181818" spread="3.0271499"/>
                    <measurement group_id="O3" value="3.8571429" spread="2.9203718"/>
                    <measurement group_id="O4" value="3.7272727" spread="3.2277208"/>
                    <measurement group_id="O5" value="3.5000000" spread="2.8216198"/>
                    <measurement group_id="O6" value="5.7142857" spread="3.0394235"/>
                    <measurement group_id="O7" value="3.5000000" spread="3.0767949"/>
                    <measurement group_id="O8" value="4.0000000" spread="3.6968455"/>
                    <measurement group_id="O9" value="3.8750000" spread="3.0523215"/>
                    <measurement group_id="O10" value="3.3750000" spread="3.0207615"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate your mouth or throat dryness while not eating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1250000" spread="2.1931217"/>
                    <measurement group_id="O2" value="1.5454545" spread="2.3393861"/>
                    <measurement group_id="O3" value="3.8571429" spread="2.7979584"/>
                    <measurement group_id="O4" value="3.0909091" spread="2.1191765"/>
                    <measurement group_id="O5" value="2.6428571" spread="2.8177226"/>
                    <measurement group_id="O6" value="4.7142857" spread="2.4976179"/>
                    <measurement group_id="O7" value="3.2500000" spread="2.7446918"/>
                    <measurement group_id="O8" value="3.4285714" spread="3.4572216"/>
                    <measurement group_id="O9" value="3.7500000" spread="3.1517191"/>
                    <measurement group_id="O10" value="2.6250000" spread="2.7222627"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate the frequency of sipping liquids to aid swallowing food</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1739130" spread="2.7741039"/>
                    <measurement group_id="O2" value="2.2727273" spread="3.1013194"/>
                    <measurement group_id="O3" value="5.1428571" spread="3.2293299"/>
                    <measurement group_id="O4" value="4.0000000" spread="3.4351128"/>
                    <measurement group_id="O5" value="5.0000000" spread="2.6602487"/>
                    <measurement group_id="O6" value="6.7142857" spread="2.6903708"/>
                    <measurement group_id="O7" value="5.0625000" spread="3.5864328"/>
                    <measurement group_id="O8" value="5.0000000" spread="3.6968455"/>
                    <measurement group_id="O9" value="5.3125000" spread="3.2397274"/>
                    <measurement group_id="O10" value="4.1250000" spread="3.6815175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate the frequency of sipping liquids for oral comfort when not eating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9565217" spread="2.7216015"/>
                    <measurement group_id="O2" value="2.0909091" spread="2.8090762"/>
                    <measurement group_id="O3" value="4.6190476" spread="3.3388050"/>
                    <measurement group_id="O4" value="3.3636364" spread="2.9076701"/>
                    <measurement group_id="O5" value="3.4285714" spread="3.1553199"/>
                    <measurement group_id="O6" value="5.2857143" spread="2.7516229"/>
                    <measurement group_id="O7" value="3.8750000" spread="3.4229617"/>
                    <measurement group_id="O8" value="3.7142857" spread="3.7733401"/>
                    <measurement group_id="O9" value="4.0000000" spread="3.4448028"/>
                    <measurement group_id="O10" value="2.7500000" spread="3.3273756"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hearing as Measured by Hearing Handicap Inventory - Adult</title>
        <description>11 item questionnaire to identify issues with hearing&#xD;
Answers are yes = 4, sometimes = 2, and no = 0&#xD;
The higher the score the more issues the participant has with hearing</description>
        <time_frame>Baseline, 1 month, and 12 months</time_frame>
        <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Baseline - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O3">
            <title>1 Month - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O4">
            <title>1 Month - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O5">
            <title>12 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O6">
            <title>12 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hearing as Measured by Hearing Handicap Inventory - Adult</title>
          <description>11 item questionnaire to identify issues with hearing&#xD;
Answers are yes = 4, sometimes = 2, and no = 0&#xD;
The higher the score the more issues the participant has with hearing</description>
          <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Does a hearing problem cause you to feel embarrassed when you meet new people?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2500000" spread="0.6079188"/>
                    <measurement group_id="O2" value="0.5454545" spread="0.9341987"/>
                    <measurement group_id="O3" value="0.2380952" spread="0.6248809"/>
                    <measurement group_id="O4" value="0.1818182" spread="0.6030227"/>
                    <measurement group_id="O5" value="0.1333333" spread="0.3518658"/>
                    <measurement group_id="O6" value="1.0000000" spread="1.0000000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Does a hearing problem cause you to feel frustrated when talking to members of your family?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1250000" spread="0.4484272"/>
                    <measurement group_id="O2" value="0.1818182" spread="0.6030227"/>
                    <measurement group_id="O3" value="0.5238095" spread="0.8728716"/>
                    <measurement group_id="O4" value="0.3636364" spread="0.8090398"/>
                    <measurement group_id="O5" value="0.1333333" spread="0.3518658"/>
                    <measurement group_id="O6" value="0.7142857" spread="0.9511897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you have difficulty hearing or understanding co-workers or clients or customers?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5000000" spread="0.8340577"/>
                    <measurement group_id="O2" value="1.0909091" spread="1.0444659"/>
                    <measurement group_id="O3" value="0.6666667" spread="0.9128709"/>
                    <measurement group_id="O4" value="1.0909091" spread="1.0444659"/>
                    <measurement group_id="O5" value="0.1333333" spread="0.3518658"/>
                    <measurement group_id="O6" value="1.7142857" spread="0.4879500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you feel that any difficulty with your hearing limits or hampers your personal or social life?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1666667" spread="0.4815434"/>
                    <measurement group_id="O2" value="0.6363636" spread="0.9244163"/>
                    <measurement group_id="O3" value="0.3809524" spread="0.7400129"/>
                    <measurement group_id="O4" value="0.7272727" spread="1.0090500"/>
                    <measurement group_id="O5" value="0.2000000" spread="0.5606119"/>
                    <measurement group_id="O6" value="0.7142857" spread="0.9511897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you feel handicapped by a hearing problem?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1250000" spread="0.4484272"/>
                    <measurement group_id="O2" value="0.5454545" spread="0.9341987"/>
                    <measurement group_id="O3" value="0.1428571" spread="0.4780914"/>
                    <measurement group_id="O4" value="0.3636364" spread="0.8090398"/>
                    <measurement group_id="O5" value="0.0666667" spread="0.2581989"/>
                    <measurement group_id="O6" value="0.7142857" spread="0.9511897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Does a hearing problem cause you difficulty in the movies or in the theater?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1666667" spread="0.4815434"/>
                    <measurement group_id="O2" value="0.4545455" spread="0.8201995"/>
                    <measurement group_id="O3" value="0.5238095" spread="0.8728716"/>
                    <measurement group_id="O4" value="0.2727273" spread="0.6466698"/>
                    <measurement group_id="O5" value="0.1333333" spread="0.5163978"/>
                    <measurement group_id="O6" value="0.4285714" spread="0.7867958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Does a hearing problem cause you difficulty when in a restaurant with relatives or friends?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2173913" spread="0.5997364"/>
                    <measurement group_id="O2" value="0.7272727" spread="0.9045340"/>
                    <measurement group_id="O3" value="0.6190476" spread="0.8646497"/>
                    <measurement group_id="O4" value="0.8181818" spread="0.9816498"/>
                    <measurement group_id="O5" value="0.2666667" spread="0.5936168"/>
                    <measurement group_id="O6" value="1.5714286" spread="0.7867958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Does a hearing problem cause you to attend religious services less often than you would like?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0416667" spread="0.2041241"/>
                    <measurement group_id="O2" value="0.1818182" spread="0.6030227"/>
                    <measurement group_id="O3" value="0.0000000" spread="0.0000000"/>
                    <measurement group_id="O4" value="0.0000000" spread="0.0000000"/>
                    <measurement group_id="O5" value="0.0000000" spread="0.0000000"/>
                    <measurement group_id="O6" value="0.0000000" spread="0.0000000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Does a hearing problem cause you to have argments with family members?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2500000" spread="0.6756639"/>
                    <measurement group_id="O2" value="0.1818182" spread="0.6030227"/>
                    <measurement group_id="O3" value="0.1000000" spread="0.4472136"/>
                    <measurement group_id="O4" value="0.1818182" spread="0.6030227"/>
                    <measurement group_id="O5" value="0.2666667" spread="0.7037316"/>
                    <measurement group_id="O6" value="0.1428571" spread="0.3779645"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Does a hearing problem cause you difficulty when listening to TV or radio?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3750000" spread="0.7109364"/>
                    <measurement group_id="O2" value="0.4545455" spread="0.8201995"/>
                    <measurement group_id="O3" value="0.8571429" spread="0.9636241"/>
                    <measurement group_id="O4" value="0.4545455" spread="0.8201995"/>
                    <measurement group_id="O5" value="0.4000000" spread="0.7367884"/>
                    <measurement group_id="O6" value="0.7142857" spread="0.9511897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Does a hearing problem cause you difficulty when visiting friends or relatives or neighbors?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3333333" spread="0.7019641"/>
                    <measurement group_id="O2" value="0.6363636" spread="0.9244163"/>
                    <measurement group_id="O3" value="0.1904762" spread="0.5117663"/>
                    <measurement group_id="O4" value="0.4545455" spread="0.8201995"/>
                    <measurement group_id="O5" value="0.1333333" spread="0.3518658"/>
                    <measurement group_id="O6" value="0.7142857" spread="0.9511897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity</title>
        <description>1 question that asks about taste acuity&#xD;
Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity&#xD;
The higher the score the worse the participant's taste acuity</description>
        <time_frame>Baseline, 1 month, 6 months, and 12 months</time_frame>
        <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Baseline - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O3">
            <title>1 Month - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O4">
            <title>1 Month - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O5">
            <title>6 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O6">
            <title>6 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O7">
            <title>12 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O8">
            <title>12 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity</title>
          <description>1 question that asks about taste acuity&#xD;
Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity&#xD;
The higher the score the worse the participant's taste acuity</description>
          <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="16"/>
                <count group_id="O8" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0833333" spread="1.1000659"/>
                    <measurement group_id="O2" value="0.9090909" spread="0.8312094"/>
                    <measurement group_id="O3" value="2.1363636" spread="1.0821255"/>
                    <measurement group_id="O4" value="2.9090909" spread="1.0444659"/>
                    <measurement group_id="O5" value="0.9285714" spread="0.7300459"/>
                    <measurement group_id="O6" value="2.4285714" spread="0.9759001"/>
                    <measurement group_id="O7" value="1.0000000" spread="0.7559289"/>
                    <measurement group_id="O8" value="1.5714286" spread="0.7867958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life as Measured by Speech Handicap Index</title>
        <description>31 questions regarding participant's speech and the effects of speech on his/her life&#xD;
The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4&#xD;
The higher the score the worse the participant's speech is affecting his/her life</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Baseline - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O3">
            <title>12 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O4">
            <title>12 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life as Measured by Speech Handicap Index</title>
          <description>31 questions regarding participant's speech and the effects of speech on his/her life&#xD;
The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4&#xD;
The higher the score the worse the participant's speech is affecting his/her life</description>
          <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>My speech makes it difficult for people to understand me</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9565217" spread="1.0215078"/>
                    <measurement group_id="O2" value="1.7272727" spread="0.9045340"/>
                    <measurement group_id="O3" value="1.3333333" spread="0.6172134"/>
                    <measurement group_id="O4" value="1.8333333" spread="1.3291601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I run out of air when I speak</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5000000" spread="0.7223151"/>
                    <measurement group_id="O2" value="1.4545455" spread="0.6875517"/>
                    <measurement group_id="O3" value="1.2666667" spread="0.7037316"/>
                    <measurement group_id="O4" value="1.8333333" spread="1.3291601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The intelligibility of my speech varies throughout the day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0000000" spread="1.0632191"/>
                    <measurement group_id="O2" value="1.5454545" spread="0.8201995"/>
                    <measurement group_id="O3" value="1.4000000" spread="0.7367884"/>
                    <measurement group_id="O4" value="1.8333333" spread="1.3291601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My speech makes me feel incompetent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3750000" spread="0.6468990"/>
                    <measurement group_id="O2" value="1.2727273" spread="0.6466698"/>
                    <measurement group_id="O3" value="1.1333333" spread="0.3518658"/>
                    <measurement group_id="O4" value="1.5000000" spread="0.8366600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>People ask me why I'm hard to understand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2916667" spread="0.6240935"/>
                    <measurement group_id="O2" value="1.1818182" spread="0.4045199"/>
                    <measurement group_id="O3" value="1.1333333" spread="0.3518658"/>
                    <measurement group_id="O4" value="1.3333333" spread="0.5163978"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I feel annoyed when people ask me to repeat</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3750000" spread="0.8242256"/>
                    <measurement group_id="O2" value="1.2727273" spread="0.6466698"/>
                    <measurement group_id="O3" value="1.3333333" spread="0.4879500"/>
                    <measurement group_id="O4" value="1.6666667" spread="1.0327956"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I avoid using the phone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6250000" spread="1.2091139"/>
                    <measurement group_id="O2" value="1.5454545" spread="0.9341987"/>
                    <measurement group_id="O3" value="1.1333333" spread="0.3518658"/>
                    <measurement group_id="O4" value="1.6666667" spread="1.0327956"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I'm tense when talking to others because of my speech</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4166667" spread="0.7172815"/>
                    <measurement group_id="O2" value="1.5454545" spread="0.8201995"/>
                    <measurement group_id="O3" value="1.0666667" spread="0.2581989"/>
                    <measurement group_id="O4" value="1.6666667" spread="1.0327956"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My articulation is unclear</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8333333" spread="0.9630868"/>
                    <measurement group_id="O2" value="1.8181818" spread="1.3506205"/>
                    <measurement group_id="O3" value="1.4666667" spread="0.7432234"/>
                    <measurement group_id="O4" value="1.8333333" spread="1.3291601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>People have difficulty understanding me in a noisy room</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8750000" spread="1.0347232"/>
                    <measurement group_id="O2" value="1.8181818" spread="0.9816498"/>
                    <measurement group_id="O3" value="1.6000000" spread="0.9856108"/>
                    <measurement group_id="O4" value="1.8333333" spread="0.9831921"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I tend to avoid groups of people because of my speech</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2500000" spread="0.6079188"/>
                    <measurement group_id="O2" value="1.727277" spread="0.9045340"/>
                    <measurement group_id="O3" value="1.2666667" spread="0.7988086"/>
                    <measurement group_id="O4" value="1.8333333" spread="1.3291601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>People seem irritated with my speech</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1250000" spread="0.3378320"/>
                    <measurement group_id="O2" value="1.3636364" spread="0.5045250"/>
                    <measurement group_id="O3" value="1.1333333" spread="0.3518658"/>
                    <measurement group_id="O4" value="1.5000000" spread="0.8366600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>People ask me to repeat myself when speaking face-to-face</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5416667" spread="0.7790276"/>
                    <measurement group_id="O2" value="1.7272727" spread="0.9045340"/>
                    <measurement group_id="O3" value="1.3333333" spread="0.4879500"/>
                    <measurement group_id="O4" value="1.8333333" spread="0.9831921"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I speak with friends and neighbors and relatives less often because of my speech</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4166667" spread="0.7172815"/>
                    <measurement group_id="O2" value="1.2727273" spread="0.6466698"/>
                    <measurement group_id="O3" value="1.2666667" spread="0.7988086"/>
                    <measurement group_id="O4" value="1.5000000" spread="0.8366600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I feel ask though I have to strain to speak</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.833333" spread="0.9630868"/>
                    <measurement group_id="O2" value="1.9090909" spread="1.1361818"/>
                    <measurement group_id="O3" value="1.2000000" spread="0.5606119"/>
                    <measurement group_id="O4" value="2.0000000" spread="1.2649111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I find other people don't understand my speaking problem</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1666667" spread="0.3806935"/>
                    <measurement group_id="O2" value="1.2727273" spread="0.6466698"/>
                    <measurement group_id="O3" value="1.0666667" spread="0.2581989"/>
                    <measurement group_id="O4" value="1.3333333" spread="0.5163978"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My speaking difficulties restrict my person and social life</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3750000" spread="0.6468990"/>
                    <measurement group_id="O2" value="1.2727273" spread="0.6466698"/>
                    <measurement group_id="O3" value="1.2000000" spread="0.5606119"/>
                    <measurement group_id="O4" value="1.5000000" spread="0.8366600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The intelligibility is unpredictable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5833333" spread="0.8805466"/>
                    <measurement group_id="O2" value="1.3636364" spread="0.8090398"/>
                    <measurement group_id="O3" value="1.1333333" spread="0.3518658"/>
                    <measurement group_id="O4" value="1.5000000" spread="0.8366600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I feel left out of conversations because of my speech</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2083333" spread="0.4148511"/>
                    <measurement group_id="O2" value="1.3636364" spread="0.6741999"/>
                    <measurement group_id="O3" value="1.3333333" spread="0.8164966"/>
                    <measurement group_id="O4" value="1.4285714" spread="0.7867958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I use a great deal of effort to speak</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8750000" spread="0.9469631"/>
                    <measurement group_id="O2" value="1.6363636" spread="0.9244163"/>
                    <measurement group_id="O3" value="1.2666667" spread="0.4577377"/>
                    <measurement group_id="O4" value="1.8571429" spread="1.0690450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My speech is worse in the evening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6250000" spread="0.8753881"/>
                    <measurement group_id="O2" value="1.6363636" spread="0.9244163"/>
                    <measurement group_id="O3" value="1.3333333" spread="0.7237469"/>
                    <measurement group_id="O4" value="1.8571429" spread="0.8997354"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My speech problem causes me to lose income</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2916667" spread="0.6902531"/>
                    <measurement group_id="O2" value="1.8181818" spread="1.2504545"/>
                    <measurement group_id="O3" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O4" value="1.4285714" spread="0.7867958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I try to change my speech to sound different</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2916667" spread="0.8064504"/>
                    <measurement group_id="O2" value="1.0909091" spread="0.3015113"/>
                    <measurement group_id="O3" value="1.0666667" spread="0.2581989"/>
                    <measurement group_id="O4" value="1.2857143" spread="0.7559289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My speech problem upsets me</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2083333" spread="0.4148511"/>
                    <measurement group_id="O2" value="1.5454545" spread="0.8201995"/>
                    <measurement group_id="O3" value="1.2666667" spread="0.4577377"/>
                    <measurement group_id="O4" value="1.8571429" spread="1.0690450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I am less outgoing because of my speech problem</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2500000" spread="0.5316095"/>
                    <measurement group_id="O2" value="1.4545455" spread="0.6875517"/>
                    <measurement group_id="O3" value="1.0666667" spread="0.2581989"/>
                    <measurement group_id="O4" value="1.4285714" spread="0.7867958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My family has difficulty understanding me when I call them throughout the house</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5000000" spread="0.7801895"/>
                    <measurement group_id="O2" value="1.6363636" spread="0.8090398"/>
                    <measurement group_id="O3" value="1.1333333" spread="0.5163978"/>
                    <measurement group_id="O4" value="1.5714286" spread="0.9759001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My speech makes me feel handicapped</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3333333" spread="0.7019641"/>
                    <measurement group_id="O2" value="1.4545455" spread="0.6875517"/>
                    <measurement group_id="O3" value="1.0666667" spread="0.2581989"/>
                    <measurement group_id="O4" value="1.5714286" spread="0.9759001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I have difficulties to continue a conversation because of my speech</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5000000" spread="0.7801895"/>
                    <measurement group_id="O2" value="1.5454545" spread="0.8201995"/>
                    <measurement group_id="O3" value="1.1333333" spread="0.3518658"/>
                    <measurement group_id="O4" value="1.8571429" spread="1.0690450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I feel embarrassed when people ask me to repeat</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2083333" spread="0.5089774"/>
                    <measurement group_id="O2" value="1.3636364" spread="0.9244163"/>
                    <measurement group_id="O3" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O4" value="1.2857143" spread="0.4879500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I'm ashamed of my speech problem</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0833333" spread="0.2823299"/>
                    <measurement group_id="O2" value="1.2727273" spread="0.9045340"/>
                    <measurement group_id="O3" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O4" value="1.2857143" spread="0.4879500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How do you rate your own speech at this moment?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1304348" spread="0.9678631"/>
                    <measurement group_id="O2" value="1.4545455" spread="0.5222330"/>
                    <measurement group_id="O3" value="1.3846154" spread="0.6504436"/>
                    <measurement group_id="O4" value="1.5714286" spread="0.7867958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life as Measured by EORTC QLQ-C30</title>
        <description>30 questions designed to assess the quality of life of cancer patients&#xD;
The first 28 questions have answers that range from 1=not at all to 4 = very much. The higher score indicates a worse quality of life&#xD;
The last 2 questions have answers that range from 1 = very poor to 7 = excellent. The higher score indicates a better quality of life</description>
        <time_frame>Baseline, 1 month, 6 months, 12 months, and 24 months</time_frame>
        <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
        <group_list>
          <group group_id="O1">
            <title>Baseline - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O2">
            <title>Baseline - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O3">
            <title>1 Month - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O4">
            <title>1 Month - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O5">
            <title>6 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O6">
            <title>6 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O7">
            <title>12 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O8">
            <title>12 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O9">
            <title>24 Months - Radiotherapy</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
          <group group_id="O10">
            <title>24 Months - Radiotherapy + Cisplatin</title>
            <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life as Measured by EORTC QLQ-C30</title>
          <description>30 questions designed to assess the quality of life of cancer patients&#xD;
The first 28 questions have answers that range from 1=not at all to 4 = very much. The higher score indicates a worse quality of life&#xD;
The last 2 questions have answers that range from 1 = very poor to 7 = excellent. The higher score indicates a better quality of life</description>
          <population>Some participants were not analyzed as the participants did not complete the questionnaires.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="16"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="17"/>
                <count group_id="O10" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Do you have trouble doing strenuous activities, like carrying a heavy shopping bag or a suitcase?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0000000" spread="0.9534626"/>
                    <measurement group_id="O2" value="2.0000000" spread="0.6324555"/>
                    <measurement group_id="O3" value="1.7727273" spread="0.9223065"/>
                    <measurement group_id="O4" value="1.4545455" spread="0.6875517"/>
                    <measurement group_id="O5" value="1.3571429" spread="0.6333237"/>
                    <measurement group_id="O6" value="1.7142857" spread="0.7559289"/>
                    <measurement group_id="O7" value="1.2666667" spread="0.5936168"/>
                    <measurement group_id="O8" value="1.5714286" spread="0.7867958"/>
                    <measurement group_id="O9" value="1.4375000" spread="0.6291529"/>
                    <measurement group_id="O10" value="1.6250000" spread="0.5175492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you have any trouble taking a long walk?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7500000" spread="0.9440892"/>
                    <measurement group_id="O2" value="1.0909091" spread="0.6015113"/>
                    <measurement group_id="O3" value="1.3636364" spread="0.5810872"/>
                    <measurement group_id="O4" value="1.2727273" spread="0.4670994"/>
                    <measurement group_id="O5" value="1.2142857" spread="0.4258153"/>
                    <measurement group_id="O6" value="1.1428571" spread="0.3779645"/>
                    <measurement group_id="O7" value="1.2666667" spread="0.4577377"/>
                    <measurement group_id="O8" value="1.1428571" spread="0.3779645"/>
                    <measurement group_id="O9" value="1.2500000" spread="0.4472136"/>
                    <measurement group_id="O10" value="1.2500000" spread="0.4629100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you have any trouble taking a short walk outside of the house?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0833333" spread="0.2823299"/>
                    <measurement group_id="O2" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O3" value="1.0454545" spread="0.2132007"/>
                    <measurement group_id="O4" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O5" value="1.0714286" spread="0.2672612"/>
                    <measurement group_id="O6" value="1.1428571" spread="0.3779645"/>
                    <measurement group_id="O7" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O8" value="1.1428571" spread="0.3779645"/>
                    <measurement group_id="O9" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O10" value="1.1250000" spread="0.3535534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you need to stay in bed or a chair during the day?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4583333" spread="0.8329709"/>
                    <measurement group_id="O2" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O3" value="1.2272727" spread="0.5284135"/>
                    <measurement group_id="O4" value="1.0909091" spread="0.3015113"/>
                    <measurement group_id="O5" value="1.1428571" spread="0.3631365"/>
                    <measurement group_id="O6" value="1.2857143" spread="0.4879500"/>
                    <measurement group_id="O7" value="1.2666667" spread="0.4577377"/>
                    <measurement group_id="O8" value="1.2857143" spread="0.4879500"/>
                    <measurement group_id="O9" value="1.1875000" spread="0.5439056"/>
                    <measurement group_id="O10" value="1.0000000" spread="0.0000000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you need help with eating, dressing, washing yourself or using the toilet?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0833333" spread="0.2823299"/>
                    <measurement group_id="O2" value="1.0909091" spread="0.3015113"/>
                    <measurement group_id="O3" value="1.0909091" spread="0.4264014"/>
                    <measurement group_id="O4" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O5" value="1.0714286" spread="0.2672612"/>
                    <measurement group_id="O6" value="1.1428571" spread="0.3779645"/>
                    <measurement group_id="O7" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O8" value="1.2857143" spread="0.4879500"/>
                    <measurement group_id="O9" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O10" value="1.0000000" spread="0.0000000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Were you limited in doing either your work or other daily activities?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0833333" spread="1.0179548"/>
                    <measurement group_id="O2" value="1.6363636" spread="1.0269106"/>
                    <measurement group_id="O3" value="1.4090909" spread="0.7341397"/>
                    <measurement group_id="O4" value="1.2727273" spread="0.6466698"/>
                    <measurement group_id="O5" value="1.4285714" spread="0.6462062"/>
                    <measurement group_id="O6" value="1.1428571" spread="0.3779645"/>
                    <measurement group_id="O7" value="1.2000000" spread="0.5606119"/>
                    <measurement group_id="O8" value="1.2857143" spread="0.4879500"/>
                    <measurement group_id="O9" value="1.3750000" spread="0.8062258"/>
                    <measurement group_id="O10" value="1.0000000" spread="0.0000000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Were you limited in pursuing your hobbies or other leisure time activities?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0000000" spread="1.0215078"/>
                    <measurement group_id="O2" value="1.6363636" spread="1.0269106"/>
                    <measurement group_id="O3" value="1.4545455" spread="0.7385489"/>
                    <measurement group_id="O4" value="1.4545455" spread="0.6875517"/>
                    <measurement group_id="O5" value="1.2857143" spread="0.6112498"/>
                    <measurement group_id="O6" value="1.4285714" spread="0.7867958"/>
                    <measurement group_id="O7" value="1.1333333" spread="0.5163978"/>
                    <measurement group_id="O8" value="1.4285714" spread="0.7867958"/>
                    <measurement group_id="O9" value="1.2500000" spread="0.5773503"/>
                    <measurement group_id="O10" value="1.3750000" spread="0.7440238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Were you short of breath?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2916667" spread="0.6240935"/>
                    <measurement group_id="O2" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O3" value="1.1363636" spread="0.3512501"/>
                    <measurement group_id="O4" value="1.3636364" spread="0.5045250"/>
                    <measurement group_id="O5" value="1.1428571" spread="0.3631365"/>
                    <measurement group_id="O6" value="1.4285714" spread="0.7867958"/>
                    <measurement group_id="O7" value="1.2666667" spread="0.5936168"/>
                    <measurement group_id="O8" value="1.4285714" spread="0.7867958"/>
                    <measurement group_id="O9" value="1.1875000" spread="0.5439056"/>
                    <measurement group_id="O10" value="1.3750000" spread="0.5175492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you had pain?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0000000" spread="0.7801895"/>
                    <measurement group_id="O2" value="1.7272727" spread="0.7862454"/>
                    <measurement group_id="O3" value="1.5000000" spread="0.5976143"/>
                    <measurement group_id="O4" value="1.7272727" spread="0.9045340"/>
                    <measurement group_id="O5" value="1.7142857" spread="0.8254203"/>
                    <measurement group_id="O6" value="1.8571429" spread="0.8997354"/>
                    <measurement group_id="O7" value="1.6000000" spread="0.7367884"/>
                    <measurement group_id="O8" value="1.8571429" spread="0.8997354"/>
                    <measurement group_id="O9" value="1.6875000" spread="0.7932003"/>
                    <measurement group_id="O10" value="2.0000000" spread="0.7559289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did you need to rest?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9166667" spread="0.8805466"/>
                    <measurement group_id="O2" value="1.5454545" spread="0.5222330"/>
                    <measurement group_id="O3" value="1.5909091" spread="0.7341397"/>
                    <measurement group_id="O4" value="1.6363636" spread="0.6741999"/>
                    <measurement group_id="O5" value="1.5000000" spread="0.7595545"/>
                    <measurement group_id="O6" value="1.7142857" spread="0.7559289"/>
                    <measurement group_id="O7" value="1.6000000" spread="0.7367884"/>
                    <measurement group_id="O8" value="1.8571429" spread="0.6900656"/>
                    <measurement group_id="O9" value="1.6875000" spread="0.7041543"/>
                    <measurement group_id="O10" value="1.6250000" spread="0.7440238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you had trouble sleeping?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8333333" spread="0.8681147"/>
                    <measurement group_id="O2" value="2.2727273" spread="1.1908744"/>
                    <measurement group_id="O3" value="1.5454545" spread="0.6709817"/>
                    <measurement group_id="O4" value="1.6363636" spread="0.6741999"/>
                    <measurement group_id="O5" value="1.3571429" spread="0.6333237"/>
                    <measurement group_id="O6" value="2.4285714" spread="0.9759001"/>
                    <measurement group_id="O7" value="1.9333333" spread="0.9611501"/>
                    <measurement group_id="O8" value="2.0000000" spread="0.8164966"/>
                    <measurement group_id="O9" value="1.3750000" spread="0.6191392"/>
                    <measurement group_id="O10" value="2.1250000" spread="0.6408699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you felt weak?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9166667" spread="0.9743076"/>
                    <measurement group_id="O2" value="1.8181818" spread="0.7507572"/>
                    <measurement group_id="O3" value="1.6818182" spread="0.8387271"/>
                    <measurement group_id="O4" value="1.4545455" spread="0.5222330"/>
                    <measurement group_id="O5" value="1.5384615" spread="0.8770580"/>
                    <measurement group_id="O6" value="1.4285714" spread="0.7867958"/>
                    <measurement group_id="O7" value="1.3333333" spread="0.6172134"/>
                    <measurement group_id="O8" value="1.5714286" spread="0.7867958"/>
                    <measurement group_id="O9" value="1.5625000" spread="0.7274384"/>
                    <measurement group_id="O10" value="1.3750000" spread="0.5175492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you lacked appetite?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6956522" spread="0.8756703"/>
                    <measurement group_id="O2" value="1.6363636" spread="0.9244163"/>
                    <measurement group_id="O3" value="1.6363636" spread="0.7267314"/>
                    <measurement group_id="O4" value="1.3636364" spread="0.5045250"/>
                    <measurement group_id="O5" value="1.3571429" spread="0.6333237"/>
                    <measurement group_id="O6" value="1.2857143" spread="0.4879500"/>
                    <measurement group_id="O7" value="1.2000000" spread="0.5606119"/>
                    <measurement group_id="O8" value="1.2857143" spread="0.7559289"/>
                    <measurement group_id="O9" value="1.5000000" spread="0.8944272"/>
                    <measurement group_id="O10" value="1.1250000" spread="0.3535534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you felt nauseated?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1666667" spread="0.6370221"/>
                    <measurement group_id="O2" value="1.3636364" spread="0.5045250"/>
                    <measurement group_id="O3" value="1.1818182" spread="0.5010811"/>
                    <measurement group_id="O4" value="1.1818182" spread="0.4045199"/>
                    <measurement group_id="O5" value="1.2142857" spread="0.4258153"/>
                    <measurement group_id="O6" value="1.1428571" spread="0.3779645"/>
                    <measurement group_id="O7" value="1.1333333" spread="0.5163978"/>
                    <measurement group_id="O8" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O9" value="1.1875000" spread="0.4031129"/>
                    <measurement group_id="O10" value="1.0000000" spread="0.0000000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you vomited?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0833333" spread="0.4082483"/>
                    <measurement group_id="O2" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O3" value="1.0454545" spread="0.2132007"/>
                    <measurement group_id="O4" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O5" value="1.0714286" spread="0.2672612"/>
                    <measurement group_id="O6" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O7" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O8" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O9" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O10" value="1.0000000" spread="0.0000000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you been constipated?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5000000" spread="0.7801895"/>
                    <measurement group_id="O2" value="1.8181818" spread="1.0787198"/>
                    <measurement group_id="O3" value="1.6363636" spread="0.7895420"/>
                    <measurement group_id="O4" value="1.0909091" spread="0.3015113"/>
                    <measurement group_id="O5" value="1.2142857" spread="0.4258153"/>
                    <measurement group_id="O6" value="1.1428571" spread="0.3779645"/>
                    <measurement group_id="O7" value="1.1333333" spread="0.3518658"/>
                    <measurement group_id="O8" value="1.5714286" spread="0.9759001"/>
                    <measurement group_id="O9" value="1.4000000" spread="0.8280787"/>
                    <measurement group_id="O10" value="1.7500000" spread="1.1649647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you had diarrhea?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0416667" spread="0.2041241"/>
                    <measurement group_id="O2" value="1.1818182" spread="0.4045199"/>
                    <measurement group_id="O3" value="1.1363636" spread="0.3512501"/>
                    <measurement group_id="O4" value="1.0000000" spread="0.0000000"/>
                    <measurement group_id="O5" value="1.1428571" spread="0.3631365"/>
                    <measurement group_id="O6" value="1.1428571" spread="0.3779645"/>
                    <measurement group_id="O7" value="1.2000000" spread="0.4140393"/>
                    <measurement group_id="O8" value="1.1428571" spread="0.3779645"/>
                    <measurement group_id="O9" value="1.0666667" spread="0.2581989"/>
                    <measurement group_id="O10" value="1.1250000" spread="0.3535534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Were you tired?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0000000" spread="0.8846517"/>
                    <measurement group_id="O2" value="2.0000000" spread="0.7745967"/>
                    <measurement group_id="O3" value="1.181818" spread="0.7950061"/>
                    <measurement group_id="O4" value="1.7272727" spread="0.6466698"/>
                    <measurement group_id="O5" value="1.6428571" spread="0.8418974"/>
                    <measurement group_id="O6" value="1.8571429" spread="0.6900656"/>
                    <measurement group_id="O7" value="1.7333333" spread="0.8837151"/>
                    <measurement group_id="O8" value="2.1428571" spread="0.6900656"/>
                    <measurement group_id="O9" value="1.4375000" spread="0.6291529"/>
                    <measurement group_id="O10" value="1.7500000" spread="0.4629100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did pain interfere with your daily activities?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6666667" spread="0.8164966"/>
                    <measurement group_id="O2" value="1.7272727" spread="0.6466698"/>
                    <measurement group_id="O3" value="1.2380952" spread="0.6248809"/>
                    <measurement group_id="O4" value="1.3000000" spread="0.4830459"/>
                    <measurement group_id="O5" value="1.2857143" spread="0.6112498"/>
                    <measurement group_id="O6" value="1.4285714" spread="0.7867958"/>
                    <measurement group_id="O7" value="1.3333333" spread="0.6172134"/>
                    <measurement group_id="O8" value="1.5714286" spread="0.7867958"/>
                    <measurement group_id="O9" value="1.1333333" spread="0.3518658"/>
                    <measurement group_id="O10" value="1.0000000" spread="0.0000000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you had difficulty in concentrating on things, like reading a newspaper or watching television</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4583333" spread="0.7790276"/>
                    <measurement group_id="O2" value="1.2727273" spread="0.6466698"/>
                    <measurement group_id="O3" value="1.2857143" spread="0.5606119"/>
                    <measurement group_id="O4" value="1.2727273" spread="0.6466698"/>
                    <measurement group_id="O5" value="1.3571429" spread="0.7449463"/>
                    <measurement group_id="O6" value="1.5714286" spread="0.7867958"/>
                    <measurement group_id="O7" value="1.4000000" spread="0.9102590"/>
                    <measurement group_id="O8" value="1.5714286" spread="0.7867958"/>
                    <measurement group_id="O9" value="1.3125000" spread="0.6020797"/>
                    <measurement group_id="O10" value="1.2500000" spread="0.4629100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did you feel tense?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3750000" spread="0.6468990"/>
                    <measurement group_id="O2" value="1.5454545" spread="0.6875517"/>
                    <measurement group_id="O3" value="1.4090909" spread="0.5903262"/>
                    <measurement group_id="O4" value="1.2727273" spread="0.4670994"/>
                    <measurement group_id="O5" value="1.2857143" spread="0.4688072"/>
                    <measurement group_id="O6" value="1.5714286" spread="0.7867958"/>
                    <measurement group_id="O7" value="1.4000000" spread="0.8280787"/>
                    <measurement group_id="O8" value="1.4285714" spread="0.7867958"/>
                    <measurement group_id="O9" value="1.1875000" spread="0.4031129"/>
                    <measurement group_id="O10" value="1.7500000" spread="1.0350983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did you worry?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9166667" spread="0.7755316"/>
                    <measurement group_id="O2" value="2.0000000" spread="0.6324555"/>
                    <measurement group_id="O3" value="1.4545455" spread="0.5958006"/>
                    <measurement group_id="O4" value="1.2727273" spread="0.4670994"/>
                    <measurement group_id="O5" value="1.3571429" spread="0.4972452"/>
                    <measurement group_id="O6" value="2.0000000" spread="0.8164966"/>
                    <measurement group_id="O7" value="1.4000000" spread="0.8280787"/>
                    <measurement group_id="O8" value="2.0000000" spread="0.8164966"/>
                    <measurement group_id="O9" value="1.4375000" spread="0.7274384"/>
                    <measurement group_id="O10" value="2.0000000" spread="0.7559289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did you feel irritable?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4166667" spread="0.8297022"/>
                    <measurement group_id="O2" value="1.5454545" spread="0.5222330"/>
                    <measurement group_id="O3" value="1.4090909" spread="0.6661253"/>
                    <measurement group_id="O4" value="1.2727273" spread="0.6466698"/>
                    <measurement group_id="O5" value="1.1428571" spread="0.5345225"/>
                    <measurement group_id="O6" value="1.7142857" spread="0.9511897"/>
                    <measurement group_id="O7" value="1.3333333" spread="0.8164966"/>
                    <measurement group_id="O8" value="1.8571429" spread="0.6900656"/>
                    <measurement group_id="O9" value="1.3125000" spread="0.6020797"/>
                    <measurement group_id="O10" value="1.6250000" spread="0.9161254"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did you feel depressed?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5416667" spread="0.8836272"/>
                    <measurement group_id="O2" value="1.4545455" spread="0.6875517"/>
                    <measurement group_id="O3" value="1.3181818" spread="0.5679004"/>
                    <measurement group_id="O4" value="1.1818182" spread="0.4045199"/>
                    <measurement group_id="O5" value="1.2142857" spread="0.4258153"/>
                    <measurement group_id="O6" value="1.5714286" spread="0.9759001"/>
                    <measurement group_id="O7" value="1.3333333" spread="0.8164966"/>
                    <measurement group_id="O8" value="1.7142857" spread="0.7559289"/>
                    <measurement group_id="O9" value="1.3125000" spread="0.6020797"/>
                    <measurement group_id="O10" value="1.5000000" spread="0.7559289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Have you had difficulty remembering things?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4166667" spread="0.7172815"/>
                    <measurement group_id="O2" value="1.2727273" spread="0.4670994"/>
                    <measurement group_id="O3" value="1.5454545" spread="0.8004328"/>
                    <measurement group_id="O4" value="1.6363636" spread="0.5045250"/>
                    <measurement group_id="O5" value="1.7142857" spread="0.8254203"/>
                    <measurement group_id="O6" value="1.8571429" spread="0.8997354"/>
                    <measurement group_id="O7" value="1.6000000" spread="0.6324555"/>
                    <measurement group_id="O8" value="2.1428571" spread="0.8997354"/>
                    <measurement group_id="O9" value="1.4375000" spread="0.5123475"/>
                    <measurement group_id="O10" value="1.8750000" spread="0.6408699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Has your physical condition or medical treatment interfered with your family life?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7916667" spread="0.8836272"/>
                    <measurement group_id="O2" value="1.5454545" spread="0.8201995"/>
                    <measurement group_id="O3" value="1.3181818" spread="0.7162311"/>
                    <measurement group_id="O4" value="1.3636364" spread="0.5045250"/>
                    <measurement group_id="O5" value="1.2142857" spread="0.4258153"/>
                    <measurement group_id="O6" value="1.4285714" spread="0.7867958"/>
                    <measurement group_id="O7" value="1.2000000" spread="0.4140393"/>
                    <measurement group_id="O8" value="1.5714286" spread="0.7867958"/>
                    <measurement group_id="O9" value="1.0625000" spread="0.2500000"/>
                    <measurement group_id="O10" value="1.1250000" spread="0.3535534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Has your physical condition or medical treatment interfered with your social activities?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0416667" spread="0.9990938"/>
                    <measurement group_id="O2" value="1.9090909" spread="1.0444659"/>
                    <measurement group_id="O3" value="1.5909091" spread="0.7963662"/>
                    <measurement group_id="O4" value="1.7272727" spread="0.9045340"/>
                    <measurement group_id="O5" value="1.1428571" spread="0.3631365"/>
                    <measurement group_id="O6" value="1.7142857" spread="0.7559289"/>
                    <measurement group_id="O7" value="1.3333333" spread="0.6172134"/>
                    <measurement group_id="O8" value="1.5714286" spread="0.7867958"/>
                    <measurement group_id="O9" value="1.1250000" spread="0.3415650"/>
                    <measurement group_id="O10" value="1.3750000" spread="0.5175492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Has your physical condition or medical treatment caused you financial difficulties?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5416667" spread="1.0206207"/>
                    <measurement group_id="O2" value="2.3636364" spread="1.2060454"/>
                    <measurement group_id="O3" value="1.5909091" spread="0.9591212"/>
                    <measurement group_id="O4" value="1.9090909" spread="1.0444659"/>
                    <measurement group_id="O5" value="1.7142857" spread="0.9944903"/>
                    <measurement group_id="O6" value="2.1428571" spread="1.0690450"/>
                    <measurement group_id="O7" value="1.4666667" spread="1.0600988"/>
                    <measurement group_id="O8" value="1.8571429" spread="0.8997354"/>
                    <measurement group_id="O9" value="1.4375000" spread="0.8139410"/>
                    <measurement group_id="O10" value="1.8750000" spread="0.9910312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How would you rate your overall health during the past week?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2083333" spread="1.2846643"/>
                    <measurement group_id="O2" value="5.2727273" spread="0.7862454"/>
                    <measurement group_id="O3" value="5.4090909" spread="1.1815684"/>
                    <measurement group_id="O4" value="5.5454545" spread="0.8201995"/>
                    <measurement group_id="O5" value="5.9285714" spread="1.2688145"/>
                    <measurement group_id="O6" value="5.2857143" spread="1.1126973"/>
                    <measurement group_id="O7" value="6.0666667" spread="1.0327956"/>
                    <measurement group_id="O8" value="5.5714286" spread="1.1338934"/>
                    <measurement group_id="O9" value="5.7500000" spread="1.1832160"/>
                    <measurement group_id="O10" value="5.7500000" spread="0.7071068"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How would you rate your overall quality of life during the past week?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0416667" spread="1.3666578"/>
                    <measurement group_id="O2" value="5.1818182" spread="0.7507572"/>
                    <measurement group_id="O3" value="5.6363636" spread="1.2167660"/>
                    <measurement group_id="O4" value="5.6363636" spread="0.8090398"/>
                    <measurement group_id="O5" value="6.1428571" spread="1.3506205"/>
                    <measurement group_id="O6" value="5.4285714" spread="0.7867958"/>
                    <measurement group_id="O7" value="6.1333333" spread="1.0600988"/>
                    <measurement group_id="O8" value="5.7142857" spread="1.1126973"/>
                    <measurement group_id="O9" value="6.0000000" spread="1.0954451"/>
                    <measurement group_id="O10" value="6.0000000" spread="0.5345225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were followed through 3 months following last date of study treatment (approximately 18 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Radiotherapy</title>
          <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
        </group>
        <group group_id="E2">
          <title>Radiotherapy, Cisplatin</title>
          <description>Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)&#xD;
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).&#xD;
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy &amp; cisplatin arm) pathways</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Xerostomia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hearing impaired</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Middle ear inflammation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Salivary duct inflammation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Localized edema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pain - oropharynx</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pain-chest (non-cardiac)</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hand infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oral thrush</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Dermatitis radiation</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Joint range decrease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Trismus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Anosmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dry nasal cavity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Post nasal drip</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Desquamation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lymphedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jason Rich, M.D.</name_or_title>
      <organization>Washington University School of Medicine</organization>
      <phone>314-747-3742</phone>
      <email>richj@wustl.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01687413
org study id: 201207059
nct id: NCT01687413
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: No
This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16
      positive oropharynx cancer patients, who have had all known disease removed surgically by a
      minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients
      can consent to participate in either the randomized (physician chooses radiotherapy arm or
      radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or
      radiotherapy & cisplatin arm) pathways. After the surgery, receive either radiation alone, or
      radiation and weekly cis-platinum during therapy. Patients are then followed for cancer,
      functional and quality of life outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Disease-free Survival (DFS)
time frame: 1 year
measure: Locoregional Control
time frame: Up to 2 years
description: Rate of patients with no recurrence at original oropharyngeal site or in the neck nodal basins.
measure: Rate of Distant Metastasis
time frame: Up to 2 years
description: Assessed by biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone.
measure: Disease Specific Survival
time frame: 1 year
measure: Number of Complications/Acute Toxicity by Organ Class
time frame: Approximately 18 weeks
description: -Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
measure: Change in Quality of Life as Measured by the MD Anderson Dysphagia Inventory
time frame: Baseline, 1 month, 6 months, 12 months, and 24 months
description: Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). Strongly agree = 1, Disagree = 2, No opinion = 3, Agree = 4, and Strongly Agree = 5
The lower the score the lower the quality of life
measure: Change in Cognitive Function as Measured by Cognitive Failures Questionnaire
time frame: Baseline, 1 month, 12 months, and 24 months
description: 25 questions to assess the frequency in which participants experience cognitive failures including forgetfulness, distractibility, and false triggering
Answers range from 0 = never to 4 = very often
The higher the score the worse the cognitive failures the participant has experienced
measure: Change in Quality of Life as Measured by Neck Dissection Impairment Index (NDII)
time frame: Baseline, 12 months, and 24 months
description: -The NDII consists of 10 questions; each with a 5 level ordinally scaled response option ranging from "not at all" to "a lot". The response for each item is then scored from 1 to 5, with 5 denoting higher quality of life (Not at all) and 1 being the least (A lot).
measure: Change in Quality of Life as Measured by University of Michigan Xerostomia Questionnaire
time frame: Baseline, 1 month, 6 months, 12 months, and 24 months
description: It contains 8 questions regarding dryness either during feeding or in the unstimulated state. Participants rate each item from 0 to 10, where 10 indicates the maximum dryness or discomfort due to dryness.
The higher the score the worse the participant's xerostomia
measure: Change in Hearing as Measured by Hearing Handicap Inventory - Adult
time frame: Baseline, 1 month, and 12 months
description: 11 item questionnaire to identify issues with hearing
Answers are yes = 4, sometimes = 2, and no = 0
The higher the score the more issues the participant has with hearing
measure: Change in Quality of Life as Measured by Scale of Subjective Total Taste Acuity
time frame: Baseline, 1 month, 6 months, and 12 months
description: 1 question that asks about taste acuity
Answers are 0 = same taste acuity as before treatment; 1 = mild loss of taste acuity, but not inconvenient in daily life; moderate loss of taste acuity, and sometimes inconvenient in daily life; severe loss of taste acuity, and frequently inconvenient in daily life; and 4 = almost complete or complete loss of taste acuity
The higher the score the worse the participant's taste acuity
measure: Change in Quality of Life as Measured by Speech Handicap Index
time frame: Baseline and 12 months
description: 31 questions regarding participant's speech and the effects of speech on his/her life
The answers for the first 30 questions range from 0 = never to 4 = always and the answers for the 31st question ranges from 0 = excellent to bad = 4
The higher the score the worse the participant's speech is affecting his/her life
measure: Change in Quality of Life as Measured by EORTC QLQ-C30
time frame: Baseline, 1 month, 6 months, 12 months, and 24 months
description: 30 questions designed to assess the quality of life of cancer patients
The first 28 questions have answers that range from 1=not at all to 4 = very much. The higher score indicates a worse quality of life
The last 2 questions have answers that range from 1 = very poor to 7 = excellent. The higher score indicates a better quality of life
arm group label: Radiotherapy
arm group type: Experimental
description: Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
arm group label: Radiotherapy, cisplatin
arm group type: Active Comparator
description: Patients undergo postoperative IMRT once daily, 5 days a week, for 6 weeks. The prescribed radiotherapy dose will be 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)
Patients also receive cisplatin 40 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 of radiation therapy (6 doses for a total of 240 mg/m2).
Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy & cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy & cisplatin arm) pathways
intervention type: Radiation
intervention name: Intensity-modulated radiation therapy (IMRT)
arm group label: Radiotherapy
arm group label: Radiotherapy, cisplatin
intervention type: Drug
intervention name: Cisplatin
arm group label: Radiotherapy, cisplatin
other name: CACP, CDDP, CPDD, DDP, Neoplatin
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Jason Rich, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Oropharyngeal Neoplasms
mesh term: Cisplatin
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 