<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/NCT02254278</url>
  </required_header>
  <id_info>
    <org_study_id>NRG-HN002</org_study_id>
    <secondary_id>NCI-2014-01279</secondary_id>
    <secondary_id>NRG-HN002</secondary_id>
    <secondary_id>NRG-HN002</secondary_id>
    <secondary_id>U10CA180868</secondary_id>
    <nct_id>NCT02254278</nct_id>
  </id_info>
  <brief_title>Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer</brief_title>
  <official_title>A Randomized Phase II Trial for Patients With p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NRG Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>NRG Oncology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized phase II trial studies the side effects and how well modestly reduced-dose&#xD;
      intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating&#xD;
      patients with oropharyngeal cancer that has spread to other places in the body (advanced).&#xD;
      Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy,&#xD;
      such as cisplatin, work in different ways to stop the growth of tumor cells, either by&#xD;
      killing the cells, by stopping them from dividing, or by stopping them from spreading. It is&#xD;
      not yet known whether IMRT is more effective with or without cisplatin in treating patients&#xD;
      with oropharyngeal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      -To select the arm(s) achieving a 2-year progression-free survival rate of &gt;= 85% without&#xD;
      unacceptable swallowing toxicity at 1 year.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
        -  To determine patterns of failure (locoregional relapse versus distant) and survival&#xD;
           -(overall and progression-free) at 6 months and 2 years.&#xD;
&#xD;
        -  To determine acute toxicity profiles at the end of radiation therapy and at 1 and 6&#xD;
           months.&#xD;
&#xD;
        -  To determine late toxicity profiles at 1 and 2 years.&#xD;
&#xD;
        -  To determine patient-reported swallowing outcomes at 6 months and 1 and 2 years.&#xD;
&#xD;
        -  To determine the predictive value of 12-14 week, post-treatment fludeoxyglucose F 18&#xD;
           (FDG)-positron emission tomography (PET)/computed tomography (CT) for locoregional&#xD;
           control and progression free survival (PFS) at 2 years.&#xD;
&#xD;
        -  To determine the predictive value of blood and tissue biomarkers for disease outcomes at&#xD;
           2 years.&#xD;
&#xD;
        -  To determine swallowing recovery per videofluoroscopy imaging at 2 years.&#xD;
&#xD;
      After completion of study treatment, patients are followed at 1 and 3 months then every 3&#xD;
      months for 2 years, every 6 months for 3 years, and then annually thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Actual">June 10, 2019</primary_completion_date>
  <phase>Phase 2</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>Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)</measure>
    <time_frame>From randomization to 2 years</time_frame>
    <description>Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Local-regional Failure</measure>
    <time_frame>From randomization to 2 years</time_frame>
    <description>Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown &gt; 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Distant Metastasis</measure>
    <time_frame>From randomization to 2 years</time_frame>
    <description>Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Alive</measure>
    <time_frame>from randomization to 2 years</time_frame>
    <description>Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Grade 3+ Adverse Events</measure>
    <time_frame>End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT</time_frame>
    <description>Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)</measure>
    <time_frame>One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2</time_frame>
    <description>The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years</measure>
    <time_frame>3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2)</time_frame>
    <description>NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown &gt; 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Detection Rate</measure>
    <time_frame>Baseline to up to 2 weeks after the completion of treatment</time_frame>
    <description>With a two-sided type error rate of 5% and based on chi-squared test for proportions, there is a greater than 99% power to detect HPV DNA detection rate of 65% and 95% between the 2 groups (n=140 in each arm). The rate of detection for each group will be summarized based on binomial distributions and a 95% confidence intervals (CI) will be provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HPV DNA Rate Decline</measure>
    <time_frame>Baseline to up to 2 weeks after the completion of treatment</time_frame>
    <description>With a two-sided type error rate of 5% and based on paired t test for means, there is 99% power to detect HPV DNA rate decline of 0.375 (effect size) within each arm (n=140). The HPV DNA rate for each group will be summarized using means and standard deviations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HPV DNA Copy Number</measure>
    <time_frame>Baseline to up to 2 weeks after the completion of treatment</time_frame>
    <description>Correlation between HPV DNA copy number and the nodal metabolic volume will be calculated using Spearman's correlation coefficient and R2, and the corresponding 95% CI will be provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variance for HPV DNA</measure>
    <time_frame>Baseline to up to 2 weeks after the completion of treatment</time_frame>
    <description>Univariable and multivariable cause specific analysis will be performed using the Cox proportional hazards model for rate of relapse.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">316</enrollment>
  <condition>Stage III Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVA Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVB Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Stage IVC Oropharyngeal Squamous Cell Carcinoma</condition>
  <condition>Tongue Carcinoma</condition>
  <arm_group>
    <arm_group_label>IMRT 6 weeks + cisplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMRT 6 weeks with concurrent cisplatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IMRT 5 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMRT 5 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>40 mg/m2 IV (intravenously) weekly for 6 weeks</description>
    <arm_group_label>IMRT 6 weeks + cisplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IMRT 6 weeks</intervention_name>
    <description>Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
    <arm_group_label>IMRT 6 weeks + cisplatin</arm_group_label>
    <other_name>Intensity-Modulated Radiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>IMRT 5 weeks</intervention_name>
    <description>Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
    <arm_group_label>IMRT 5 weeks</arm_group_label>
    <other_name>Intensity-Modulated Radiotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Step 1: Registration:&#xD;
&#xD;
          1. Pathologically (histologically or cytologically) proven diagnosis of squamous cell&#xD;
             carcinoma (including the histological variants papillary squamous cell carcinoma and&#xD;
             basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft&#xD;
             palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is&#xD;
             sufficient in the presence of clinical evidence of a primary tumor in the oropharynx.&#xD;
             Clinical evidence should be documented, may consist of palpation, imaging, or&#xD;
             endoscopic evaluation, and should be sufficient to estimate the size of the primary&#xD;
             (for T stage).&#xD;
&#xD;
          2. Patients must have clinically or radiographically evident measurable disease at the&#xD;
             primary site or at nodal stations. Tonsillectomy or local excision of the primary&#xD;
             without removal of nodal disease is permitted, as is excision removing gross nodal&#xD;
             disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes&#xD;
             are permitted and considered as non-therapeutic nodal excisions.&#xD;
&#xD;
          3. Immunohistochemical staining for p16 must be performed on tissue, and this tissue must&#xD;
             be submitted for central review. Fine needle aspiration (FNA) biopsy specimens may be&#xD;
             used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block&#xD;
             material is available for p16 immunohistochemistry. FNA specimens prepared with&#xD;
             adequate p16 testing in this manner are acceptable to submit for central review. If&#xD;
             the p16 preparation is not adequate, additional specimens will be required to&#xD;
             establish p16 status. Centers are encouraged to contact the pathology chairs for&#xD;
             clarification.&#xD;
&#xD;
          4. Clinical stage T1-T2, N1-N2b or T3, N0-N2b (AJCC, 7th ed.) including no distant&#xD;
             metastases based on the following diagnostic workup:&#xD;
&#xD;
               -  General history and physical examination within 56 days prior to registration;&#xD;
&#xD;
               -  Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct&#xD;
                  procedure) within 70 days prior to registration;&#xD;
&#xD;
               -  One of the following combinations of imaging is required within 56 days prior to&#xD;
                  registration:&#xD;
&#xD;
                    1. A computed tomography (CT) scan of the neck (with contrast) and a chest CT&#xD;
                       scan (with or without contrast);&#xD;
&#xD;
                    2. or an MRI of the neck (with contrast) and a chest CT scan (with or without&#xD;
                       contrast);&#xD;
&#xD;
                    3. or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or&#xD;
                       without contrast);&#xD;
&#xD;
                    4. or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with&#xD;
                       or without contrast).&#xD;
&#xD;
             Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation&#xD;
             planning may serve as both staging and planning tools.&#xD;
&#xD;
          5. Patients must provide their personal smoking history prior to registration. The&#xD;
             lifetime cumulative history cannot exceed 10 pack-years. The following formula is used&#xD;
             to calculate the pack-years during the periods of smoking in the patient's life; the&#xD;
             cumulative total of the number of pack-years during each period of active smoking is&#xD;
             the lifetime cumulative history.&#xD;
&#xD;
             Number of pack-years = [Frequency of smoking (number of cigarettes per day) × duration&#xD;
             of cigarette smoking (years)] / 20&#xD;
&#xD;
             Note: Twenty cigarettes is considered equivalent to one pack. The effect of&#xD;
             non-cigarette tobacco products on the survival of patients with p16-positive&#xD;
             oropharyngeal cancers is undefined. While there are reportedly increased risks of head&#xD;
             and neck cancer associated with sustained heavy cigar and pipe use (Wyss 2013), such&#xD;
             sustained use of non-cigarette products is unusual and does not appear to convey added&#xD;
             risk with synchronous cigarette smoking. Cigar and pipe tobacco consumption is&#xD;
             therefore not included in calculating the lifetime pack-years. Marijuana consumption&#xD;
             is likewise not considered in this calculation. There is no clear scientific evidence&#xD;
             regarding the role of chewing tobacco-containing products in this disease, although&#xD;
             this is possibly more concerning given the proximity of the oral cavity and&#xD;
             oropharynx. In any case, investigators are discouraged from enrolling patients with a&#xD;
             history of very sustained use (such as several years or more) of non-cigarette tobacco&#xD;
             products alone.&#xD;
&#xD;
          6. Zubrod Performance Status of 0-1 within 56 days prior to registration;&#xD;
&#xD;
          7. Age ≥ 18;&#xD;
&#xD;
          8. The trial is open to both genders;&#xD;
&#xD;
          9. Adequate hematologic function within 14 days prior to registration, defined as&#xD;
             follows:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;&#xD;
&#xD;
               -  Platelets ≥ 100,000 cells/mm3;&#xD;
&#xD;
               -  Hemoglobin (Hgb) ≥ 8.0 g/dl; Note: The use of transfusion or other intervention&#xD;
                  to achieve Hgb ≥ 8.0 g/dl is acceptable.&#xD;
&#xD;
         10. Adequate renal function within 14 days prior to registration, defined as follows:&#xD;
&#xD;
             • Serum creatinine (Cr) &lt; 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min&#xD;
             determined by 24-hour collection or estimated by Cockcroft-Gault formula:&#xD;
&#xD;
               -  CC male = [(140 - age) x (wt in kg)] / [(Serum Cr mg/dl) x (72)]&#xD;
&#xD;
               -  CC female = 0.85 x (CC male)&#xD;
&#xD;
         11. Adequate hepatic function within 14 days prior to registration defined as follows:&#xD;
&#xD;
               -  Bilirubin &lt; 2 mg/dl;&#xD;
&#xD;
               -  Aspartate transaminase (AST) or alanine transaminase (ALT) &lt; 3 x the upper limit&#xD;
                  of normal.&#xD;
&#xD;
         12. Negative serum pregnancy test within 14 days prior to registration for women of&#xD;
             childbearing potential;&#xD;
&#xD;
         13. Patients who are HIV positive but have no prior Acquired Immune Deficiency Syndrome&#xD;
             (AIDS) -defining illness and have CD4 cells of at least 350/mm3 are eligible.&#xD;
             HIV-positive patients must not have multi-drug resistant HIV infection or other&#xD;
             concurrent AIDS-defining conditions. Patients must not be sero-positive for Hepatitis&#xD;
             B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or&#xD;
             sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients&#xD;
             who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are&#xD;
             eligible (e.g. patients immunized against hepatitis B).&#xD;
&#xD;
         14. The patient must provide study-specific informed consent prior to study entry,&#xD;
             including consent for mandatory submission of tissue for required, central p16 review.&#xD;
&#xD;
         15. Patients who speak English (or read one of the languages for which a translation is&#xD;
             available (see Section 10.2) must consent to complete the mandatory dysphagia-related&#xD;
             patient reported instrument (MDADI). If the patient cannot understand spoken English&#xD;
             and reads only languages not available in the MDADI translations, the patient can&#xD;
             still participate in the trial, as this has been factored into the trial statistics.&#xD;
             For all other patients, the MDADI is mandatory as it is included in the primary&#xD;
             endpoint to be studied.&#xD;
&#xD;
             Step 2: Randomization:&#xD;
&#xD;
         16. p16 positive by immunohistochemistry (defined as greater than 70% strong nuclear or&#xD;
             nuclear and cytoplasmic staining of tumor cells), confirmed by central pathology&#xD;
             review; (see Section 10.1 for details).&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Step 1: Registration:&#xD;
&#xD;
          1. Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar&#xD;
             ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16&#xD;
             positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas;&#xD;
&#xD;
          2. Carcinoma of the neck of unknown primary site origin (even if p16 positive);&#xD;
&#xD;
          3. Radiographically matted nodes, defined as 3 abutting nodes with loss of the&#xD;
             intervening fat plane;&#xD;
&#xD;
          4. Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as&#xD;
             the clavicle;&#xD;
&#xD;
          5. Definitive clinical or radiologic evidence of metastatic disease or adenopathy below&#xD;
             the clavicles;&#xD;
&#xD;
          6. Gross total excision of both primary and nodal disease with curative intent; this&#xD;
             includes tonsillectomy, local excision of primary site, and nodal excision that&#xD;
             removes all clinically and radiographically evident disease. In other words, to&#xD;
             participate in this protocol, the patient must have clinically or radiographically&#xD;
             evident gross disease for which disease response can be assessed.&#xD;
&#xD;
          7. Patients with simultaneous primary cancers or separate bilateral primary tumor sites&#xD;
             are excluded with the exception of patients with bilateral tonsil cancers;&#xD;
&#xD;
          8. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free&#xD;
             for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast,&#xD;
             oral cavity, or cervix are all permissible);&#xD;
&#xD;
          9. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a&#xD;
             different cancer is allowable;&#xD;
&#xD;
         10. Prior radiotherapy to the region of the study cancer that would result in overlap of&#xD;
             radiation therapy fields;&#xD;
&#xD;
         11. Severe, active co-morbidity defined as follows:&#xD;
&#xD;
               -  Unstable angina and/or congestive heart failure requiring hospitalization within&#xD;
                  the last 6 months;&#xD;
&#xD;
               -  Transmural myocardial infarction within the last 6 months;&#xD;
&#xD;
               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time&#xD;
                  of registration;&#xD;
&#xD;
               -  Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness&#xD;
                  requiring hospitalization or precluding study therapy within 30 days of&#xD;
                  registration;&#xD;
&#xD;
               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;&#xD;
                  note, however, that laboratory tests for liver function and coagulation&#xD;
                  parameters are not required for entry into this protocol other than those&#xD;
                  requested in Section 3.2.10.&#xD;
&#xD;
               -  Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease&#xD;
                  Control and Prevention (CDC) definition with immune compromise greater than that&#xD;
                  noted in Inclusion Criterion 13; note, however, that HIV testing is not required&#xD;
                  for entry into this protocol. The need to exclude patients with AIDS from this&#xD;
                  protocol is necessary because the treatments involved in this protocol may be&#xD;
                  significantly immunosuppressive. Protocol-specific requirements may also exclude&#xD;
                  immuno-compromised patients.&#xD;
&#xD;
         12. Pregnancy; this exclusion is necessary because the treatment involved in this study&#xD;
             may be significantly teratogenic.&#xD;
&#xD;
         13. Prior allergic reaction to cisplatin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sue Yom</last_name>
    <role>Principal Investigator</role>
    <affiliation>NRG Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham Cancer Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Center - Tucson</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alta Bates Summit Medical Center-Herrick Campus</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>94704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mills-Peninsula Medical Center</name>
      <address>
        <city>Burlingame</city>
        <state>California</state>
        <zip>94010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Cancer Centers Radiation Oncology Services-Cameron Park</name>
      <address>
        <city>Cameron Park</city>
        <state>California</state>
        <zip>95682</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marin General Hospital</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Los Angeles Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center</name>
      <address>
        <city>Modesto</city>
        <state>California</state>
        <zip>95355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Oakland-Broadway</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Irvine Health/Chao Family Comprehensive Cancer Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation Health Care</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Institute Palo Alto</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Rancho Cordova Cancer Center</name>
      <address>
        <city>Rancho Cordova</city>
        <state>California</state>
        <zip>95670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rohnert Park Cancer Center</name>
      <address>
        <city>Rohnert Park</city>
        <state>California</state>
        <zip>94928</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Cancer Centers Radiation Oncology Services-Roseville</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Permanente Medical Group-Roseville Radiation Oncology</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95678</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Medical Center Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Sacramento Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Helena Hospital</name>
      <address>
        <city>Saint Helena</city>
        <state>California</state>
        <zip>94574</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naval Medical Center -San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Medical Center-Mount Zion</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Center South Bay</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center - Santa Clara</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope South Pasadena</name>
      <address>
        <city>South Pasadena</city>
        <state>California</state>
        <zip>91030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Cancer Treatment Center</name>
      <address>
        <city>South San Francisco</city>
        <state>California</state>
        <zip>94080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation-Sunnyvale</name>
      <address>
        <city>Sunnyvale</city>
        <state>California</state>
        <zip>94086</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gene Upshaw Memorial Tahoe Forest Cancer Center</name>
      <address>
        <city>Truckee</city>
        <state>California</state>
        <zip>96161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Muir Medical Center-Walnut Creek</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Boulder</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penrose-Saint Francis Healthcare</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poudre Valley Hospital</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80524</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Colorado Medical Center</name>
      <address>
        <city>Greeley</city>
        <state>Colorado</state>
        <zip>80631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parker Adventist Hospital</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Health System-Christiana Hospital</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beebe Health Campus</name>
      <address>
        <city>Rehoboth Beach</city>
        <state>Delaware</state>
        <zip>19971</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Regional Hospital/Joe DiMaggio Children's Hospital</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine-Sylvester Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital West</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic-Weston</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grady Health System</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Saint Joseph's Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lewis Cancer and Research Pavilion at Saint Joseph's/Candler</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Center of Hawaii-Liliha</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John H Stroger Jr Hospital of Cook County</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Decatur Memorial Hospital</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem-Evanston Hospital</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem-Glenbrook Hospital</name>
      <address>
        <city>Glenview</city>
        <state>Illinois</state>
        <zip>60026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem-Highland Park Hospital</name>
      <address>
        <city>Highland Park</city>
        <state>Illinois</state>
        <zip>60035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Associates PC</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Hospital Randallia</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital of South Bend</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence Memorial Hospital</name>
      <address>
        <city>Lawrence</city>
        <state>Kansas</state>
        <zip>66044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olathe Medical Center</name>
      <address>
        <city>Olathe</city>
        <state>Kansas</state>
        <zip>66061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center-Overland Park</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Via Christi Hospitals Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The James Graham Brown Cancer Center at University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish Hospital Medical Center Northeast</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Baltimore Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Hospital and Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Cancer Institute-Downriver</name>
      <address>
        <city>Brownstown</city>
        <state>Michigan</state>
        <zip>48183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Macomb Hospital-Clinton Township</name>
      <address>
        <city>Clinton Township</city>
        <state>Michigan</state>
        <zip>48038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health Saint Mary's</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary Mercy Hospital</name>
      <address>
        <city>Livonia</city>
        <state>Michigan</state>
        <zip>48154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health Mercy Campus</name>
      <address>
        <city>Muskegon</city>
        <state>Michigan</state>
        <zip>49444</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeland Medical Center Saint Joseph</name>
      <address>
        <city>Saint Joseph</city>
        <state>Michigan</state>
        <zip>49085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford West Bloomfield Hospital</name>
      <address>
        <city>West Bloomfield</city>
        <state>Michigan</state>
        <zip>48322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coborn Cancer Center at Saint Cloud Hospital</name>
      <address>
        <city>Saint Cloud</city>
        <state>Minnesota</state>
        <zip>56303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Clinic - Saint Louis Park</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Regional Medical Center</name>
      <address>
        <city>Shakopee</city>
        <state>Minnesota</state>
        <zip>55379</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at West County Hospital</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Kansas City Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center-South</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center-North</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center-Lee's Summit</name>
      <address>
        <city>Lee's Summit</city>
        <state>Missouri</state>
        <zip>64064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delbert Day Cancer Institute at PCRMC</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</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>
    <facility>
      <name>Mercy Hospital Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Saint Peters Hospital</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63376</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CoxHealth South Hospital</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benefis Healthcare- Sletten Cancer Institute</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Medical Hospital</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Health Saint Francis</name>
      <address>
        <city>Grand Island</city>
        <state>Nebraska</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Bergan Mercy Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Lakeside Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Centers of Nevada Central</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renown Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wentworth-Douglass Hospital</name>
      <address>
        <city>Dover</city>
        <state>New Hampshire</state>
        <zip>03820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Barnabas Medical Center</name>
      <address>
        <city>Livingston</city>
        <state>New Jersey</state>
        <zip>07039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Memorial</name>
      <address>
        <city>Mount Holly</city>
        <state>New Jersey</state>
        <zip>08060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Voorhees</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Cancer Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dickstein Cancer Treatment Center</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Hospital Inc-Memorial Campus</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vidant Oncology-Kinston</name>
      <address>
        <city>Kinston</city>
        <state>North Carolina</state>
        <zip>28501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHRMC Radiation Oncology - Supply</name>
      <address>
        <city>Supply</city>
        <state>North Carolina</state>
        <zip>28462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHRMC Radiation Oncology - 16th Street</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UHHS-Chagrin Highlands Medical Center</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geauga Hospital</name>
      <address>
        <city>Chardon</city>
        <state>Ohio</state>
        <zip>44024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati/Barrett Cancer Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Cancer Center/Fairview Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Cancer Center-Elyria</name>
      <address>
        <city>Elyria</city>
        <state>Ohio</state>
        <zip>44035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Cancer Center Independence</name>
      <address>
        <city>Independence</city>
        <state>Ohio</state>
        <zip>44131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillcrest Hospital Cancer Center</name>
      <address>
        <city>Mayfield Heights</city>
        <state>Ohio</state>
        <zip>44124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UH Seidman Cancer Center at Lake Health Mentor Campus</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UH Seidman Cancer Center at Southwest General Hospital</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Parma Medical Center</name>
      <address>
        <city>Parma</city>
        <state>Ohio</state>
        <zip>44129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Coast Cancer Care</name>
      <address>
        <city>Sandusky</city>
        <state>Ohio</state>
        <zip>44870</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UH Seidman Cancer Center at Firelands Regional Medical Center</name>
      <address>
        <city>Sandusky</city>
        <state>Ohio</state>
        <zip>44870</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Cancer Center Strongsville</name>
      <address>
        <city>Strongsville</city>
        <state>Ohio</state>
        <zip>44136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProMedica Flower Hospital</name>
      <address>
        <city>Sylvania</city>
        <state>Ohio</state>
        <zip>43560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Pointe</name>
      <address>
        <city>West Chester</city>
        <state>Ohio</state>
        <zip>45069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UHHS-Westlake Medical Center</name>
      <address>
        <city>Westlake</city>
        <state>Ohio</state>
        <zip>44145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Wooster Family Health and Surgery Center</name>
      <address>
        <city>Wooster</city>
        <state>Ohio</state>
        <zip>44691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Oklahoma City</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Mount Hood Medical Center</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Memorial Hospital</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC-Heritage Valley Health System Beaver</name>
      <address>
        <city>Beaver</city>
        <state>Pennsylvania</state>
        <zip>15009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Cancer Centers - Arnold Palmer Pavilion</name>
      <address>
        <city>Greensburg</city>
        <state>Pennsylvania</state>
        <zip>15601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033-0850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC-Johnstown/John P. Murtha Regional Cancer Center</name>
      <address>
        <city>Johnstown</city>
        <state>Pennsylvania</state>
        <zip>15901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Cancer Center at UPMC McKeesport</name>
      <address>
        <city>McKeesport</city>
        <state>Pennsylvania</state>
        <zip>15132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC-Coraopolis/Heritage Valley Radiation Oncology</name>
      <address>
        <city>Moon</city>
        <state>Pennsylvania</state>
        <zip>15108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC-Saint Margaret</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC-Shadyside Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC-Passavant Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Cancer Center at UPMC Northwest</name>
      <address>
        <city>Seneca</city>
        <state>Pennsylvania</state>
        <zip>16346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Uniontown Hospital Radiation Oncology</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Washington Hospital Radiation Oncology</name>
      <address>
        <city>Washington</city>
        <state>Pennsylvania</state>
        <zip>15301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reading Hospital</name>
      <address>
        <city>West Reading</city>
        <state>Pennsylvania</state>
        <zip>19611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Health System Cancer Institute-Faris</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Health System Cancer Institute-Eastside</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Health System Cancer Institute-Greer</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Health System Cancer Institute-Seneca</name>
      <address>
        <city>Seneca</city>
        <state>South Carolina</state>
        <zip>29672</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spartanburg Medical Center</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Health System Cancer Institute-Spartanburg</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Cancer Specialists-Dowell Springs</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555-0565</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson in Katy</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77094</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UTMB Cancer Center at Victory Lakes</name>
      <address>
        <city>League City</city>
        <state>Texas</state>
        <zip>77573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson League City</name>
      <address>
        <city>Nassau Bay</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson in The Woodlands</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McKay-Dee Hospital Center</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Cancer Specialists-Salt Lake City</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute/University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norris Cotton Cancer Center-North</name>
      <address>
        <city>Saint Johnsbury</city>
        <state>Vermont</state>
        <zip>05819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Cancer Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tacoma/Valley Radiation Oncology Centers-Gig Harbor</name>
      <address>
        <city>Gig Harbor</city>
        <state>Washington</state>
        <zip>98332</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tacoma/Valley Radiation Oncology Centers-Jackson Hall</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>97405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Tacoma General Hospital</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tacoma/Valley Radiation Oncology Centers-Saint Joe's</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Salmon Creek Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center Green Bay</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center at Saint Mary's</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UW Cancer Center Johnson Creek</name>
      <address>
        <city>Johnson Creek</city>
        <state>Wisconsin</state>
        <zip>53038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gundersen Lutheran Medical Center</name>
      <address>
        <city>La Crosse</city>
        <state>Wisconsin</state>
        <zip>54601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Hospital and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Memorial Hospital</name>
      <address>
        <city>Menomonee Falls</city>
        <state>Wisconsin</state>
        <zip>53051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension All Saints Hospital</name>
      <address>
        <city>Racine</city>
        <state>Wisconsin</state>
        <zip>53405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HSHS Saint Nicholas Hospital</name>
      <address>
        <city>Sheboygan</city>
        <state>Wisconsin</state>
        <zip>53081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alyce and Elmore Kraemer Cancer Care Center</name>
      <address>
        <city>West Bend</city>
        <state>Wisconsin</state>
        <zip>53095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus UW Cancer Center</name>
      <address>
        <city>Wisconsin Rapids</city>
        <state>Wisconsin</state>
        <zip>54494</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA-Vancouver Island Cancer Centre</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R 6V5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre at Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingston Health Sciences Centre</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odette Cancer Centre- Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network-Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Windsor Regional Cancer Centre</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 2X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM - Hopital Notre-Dame</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Department of Oncology</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2W 1S6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allan Blair Cancer Centre</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4T 7T1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saskatoon Cancer Centre</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 4H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Lukes Hospital</name>
      <address>
        <city>Dublin</city>
        <state>Co Dublin</state>
        <zip>6</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Faisal Specialist Hospital and Research Centre</name>
      <address>
        <city>Riyadh</city>
        <zip>11211</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Ireland</country>
    <country>Saudi Arabia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>June 25, 2020</results_first_submitted>
  <results_first_submitted_qc>July 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 12, 2020</results_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</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>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_browse>
  <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>December 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT02254278/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT02254278/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>After first step registration and prior to randomization, patients were tested for p16. Only patients with p16-positive tumors continued on to randomization. In total, 316 patients were enrolled and 308 were randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>IMRT 6 Weeks + Cisplatin</title>
          <description>Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks&#xD;
IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
        </group>
        <group group_id="P2">
          <title>IMRT 5 Weeks</title>
          <description>IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="158"/>
                <participants group_id="P2" count="150"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Eligible</title>
              <participants_list>
                <participants group_id="P1" count="157"/>
                <participants group_id="P2" count="149"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Started Study Treatment</title>
              <participants_list>
                <participants group_id="P1" count="152"/>
                <participants group_id="P2" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Negative Post-treatment PET</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="157"/>
                <participants group_id="P2" count="149"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized and eligible patients</population>
      <group_list>
        <group group_id="B1">
          <title>IMRT 6 Weeks + Cisplatin</title>
          <description>Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks&#xD;
IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
        </group>
        <group group_id="B2">
          <title>IMRT 5 Weeks</title>
          <description>IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</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="157"/>
            <count group_id="B2" value="149"/>
            <count group_id="B3" value="306"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>≤ 49</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50 - 59</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60 - 69</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 70</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="47"/>
                  </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="24"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="257"/>
                  </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="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="130"/>
                    <measurement group_id="B3" value="273"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </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="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="151"/>
                    <measurement group_id="B2" value="130"/>
                    <measurement group_id="B3" value="281"/>
                  </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="4"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Zubrod performance status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0: Asymptomatic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1: Symptomatic but completely ambulatory</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking history (pack years)</title>
          <description>Smoking history as measured in pack-years, calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="213"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;0 - &lt;5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 - 10</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary tumor site</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Oropharynx NOS (not otherwise specified)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Tonsillar fossa, tonsil</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Base of tongue</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="126"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pharyngeal oropharynx</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>Posterior pharyngeal wall</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>T stage, clinical</title>
          <description>Tumor stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>T1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>T2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
                <category>
                  <title>T3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>N stage, clinical</title>
          <description>Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 7th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. The higher the number after the N, the greater the involvement of regional lymph nodes.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>N0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N2a</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N2b</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Radiation Therapy (RT) planning (as stratified)</title>
          <description>Radiation therapy plan included unilateral or bilateral radiation to the neck, as provided by the treating site at stratification.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Unilateral</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bilateral</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>RT planning (per central review)</title>
          <description>Radiation therapy plan included unilateral or bilateral radiation to the neck, as provided by central review by the study radiation oncologist.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Unilateral</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bilateral</title>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="261"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)</title>
        <description>Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.</description>
        <time_frame>From randomization to 2 years</time_frame>
        <population>Two-year data was available for 147/157 (Arm 1) and 145/149 (Arm 2) randomized and eligible participants.</population>
        <group_list>
          <group group_id="O1">
            <title>IMRT 6 Weeks + Cisplatin (Arm 1)</title>
            <description>Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks&#xD;
IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
          <group group_id="O2">
            <title>IMRT 5 Weeks (Arm 2)</title>
            <description>IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)</title>
          <description>Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.</description>
          <population>Two-year data was available for 147/157 (Arm 1) and 145/149 (Arm 2) randomized and eligible participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="147"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" lower_limit="86.6" upper_limit="NA">one-side confidence interval</measurement>
                    <measurement group_id="O2" value="87.6" lower_limit="83.3" upper_limit="NA">one-side confidence interval</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year progression-free survival (PFS) rate ≤ 85% against the alternative hypothesis of &gt; 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.04</p_value>
            <method>binomial</method>
            <method_desc>One-sided significance level=0.10</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year PFS rate ≤ 85% against the alternative hypothesis of &gt; 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.23</p_value>
            <method>bionmial</method>
            <method_desc>One-sided significance level = 0.10</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Local-regional Failure</title>
        <description>Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown &gt; 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.</description>
        <time_frame>From randomization to 2 years</time_frame>
        <population>Randomized and eligible participants</population>
        <group_list>
          <group group_id="O1">
            <title>IMRT 6 Weeks + Cisplatin</title>
            <description>Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks&#xD;
IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
          <group group_id="O2">
            <title>IMRT 5 Weeks</title>
            <description>IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Local-regional Failure</title>
          <description>Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown &gt; 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.</description>
          <population>Randomized and eligible participants</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Six months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="0.1" upper_limit="3.3"/>
                    <measurement group_id="O2" value="2.0" lower_limit="0.6" upper_limit="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="1.2" upper_limit="7.1"/>
                    <measurement group_id="O2" value="9.5" lower_limit="5.5" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Log Rank</method>
            <method_desc>Two-sided significance level = 0.05</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.17</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
            <estimate_desc>Reference level = IMRT 5 weeks</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Distant Metastasis</title>
        <description>Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.</description>
        <time_frame>From randomization to 2 years</time_frame>
        <population>Randomized and eligible participants</population>
        <group_list>
          <group group_id="O1">
            <title>IMRT 6 Weeks + Cisplatin</title>
            <description>Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks&#xD;
IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
          <group group_id="O2">
            <title>IMRT 5 Weeks</title>
            <description>IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Distant Metastasis</title>
          <description>Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.</description>
          <population>Randomized and eligible participants</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Six months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="1.6" upper_limit="8.0"/>
                    <measurement group_id="O2" value="2.1" lower_limit="0.6" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.58</p_value>
            <method>Log Rank</method>
            <method_desc>Two-sided significance level = 0.05</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>5.08</ci_upper_limit>
            <estimate_desc>Reference level = IMRT 5 weeks</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Alive</title>
        <description>Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.</description>
        <time_frame>from randomization to 2 years</time_frame>
        <population>Randomized and eligible participants</population>
        <group_list>
          <group group_id="O1">
            <title>IMRT 6 Weeks + Cisplatin</title>
            <description>Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks&#xD;
IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
          <group group_id="O2">
            <title>IMRT 5 Weeks</title>
            <description>IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Alive</title>
          <description>Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.</description>
          <population>Randomized and eligible participants</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Six months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="98.1" upper_limit="100"/>
                    <measurement group_id="O2" value="98.0" lower_limit="95.7" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.7" lower_limit="93.9" upper_limit="99.5"/>
                    <measurement group_id="O2" value="97.3" lower_limit="94.6" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.93</p_value>
            <p_value_desc>Two-side significance level = 0.05</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>2.95</ci_upper_limit>
            <estimate_desc>Reference level = IMRT 5 weeks</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Grade 3+ Adverse Events</title>
        <description>Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.</description>
        <time_frame>End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT</time_frame>
        <population>Randomized and eligible participants who started study treatment. Adverse event data was not available for all participants at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>IMRT 6 Weeks + Cisplatin (Arm 1)</title>
            <description>Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks&#xD;
IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
          <group group_id="O2">
            <title>IMRT 5 Weeks (Arm 2)</title>
            <description>IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Grade 3+ Adverse Events</title>
          <description>Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.</description>
          <population>Randomized and eligible participants who started study treatment. Adverse event data was not available for all participants at each time point.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>End of RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.7" lower_limit="65.9" upper_limit="80.5"/>
                    <measurement group_id="O2" value="46.3" lower_limit="38.0" upper_limit="54.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1" lower_limit="28.3" upper_limit="44.5"/>
                    <measurement group_id="O2" value="28.2" lower_limit="21.0" upper_limit="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="140"/>
                    <count group_id="O2" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9" lower_limit="11.9" upper_limit="25.2"/>
                    <measurement group_id="O2" value="11.1" lower_limit="6.2" upper_limit="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="8.8" upper_limit="20.8"/>
                    <measurement group_id="O2" value="9.0" lower_limit="4.7" upper_limit="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 years post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" lower_limit="4.4" upper_limit="14.9"/>
                    <measurement group_id="O2" value="7.4" lower_limit="3.4" upper_limit="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>End of RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Fisher Exact</method>
            <method_desc>Two-sided significance level = 0.05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>One month after end of RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.17</p_value>
            <method>Fisher Exact</method>
            <method_desc>Two-sided significance level = 0.05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Six months after end of RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.16</p_value>
            <method>Fisher Exact</method>
            <method_desc>Two-side significance level = 0.05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>One year after end of RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.26</p_value>
            <method>Fisher Exact</method>
            <method_desc>Two-side significance level = 0.05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Two years after the end of RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.82</p_value>
            <method>Fisher Exact</method>
            <method_desc>Two-side significance level = 0.05</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)</title>
        <description>The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia.</description>
        <time_frame>One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2</time_frame>
        <population>Randomized and eligible participants. Questionnaires were not completed by all participants. 121 Arm 1 and 106 Arm 2 participants had one year post-RT data.</population>
        <group_list>
          <group group_id="O1">
            <title>IMRT 6 Weeks + Cisplatin (Arm 1)</title>
            <description>Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks&#xD;
IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
          <group group_id="O2">
            <title>IMRT 5 Weeks (Arm 2)</title>
            <description>IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)</title>
          <description>The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia.</description>
          <population>Randomized and eligible participants. Questionnaires were not completed by all participants. 121 Arm 1 and 106 Arm 2 participants had one year post-RT data.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.3" lower_limit="82.5" upper_limit="88.1"/>
                    <measurement group_id="O2" value="81.8" lower_limit="79.0" upper_limit="84.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years</title>
        <description>NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown &gt; 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis.</description>
        <time_frame>3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2)</time_frame>
        <population>Randomized and eligible participants with negative post-treatment PET</population>
        <group_list>
          <group group_id="O1">
            <title>Both Arms Combined</title>
            <description>IMRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy.&#xD;
IMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years</title>
          <description>NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown &gt; 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis.</description>
          <population>Randomized and eligible participants with negative post-treatment PET</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Progression-free Survival</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.0" lower_limit="87.7" upper_limit="NA">One-sided interval</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Local-regional failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.5" lower_limit="90.6" upper_limit="NA">One-side interval</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Progression-free survival: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of &gt; 90% with a 1-sided binomial test at the 0.10 level.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3</p_value>
            <method>binomial test</method>
            <method_desc>One-sided significance level = 0.10</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Local-regional control: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of &gt; 90% with a 1-sided binomial test at the 0.10 level.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.07</p_value>
            <method>binomial test</method>
            <method_desc>One-sided significance level = 0.10</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Detection Rate</title>
        <description>With a two-sided type error rate of 5% and based on chi-squared test for proportions, there is a greater than 99% power to detect HPV DNA detection rate of 65% and 95% between the 2 groups (n=140 in each arm). The rate of detection for each group will be summarized based on binomial distributions and a 95% confidence intervals (CI) will be provided.</description>
        <time_frame>Baseline to up to 2 weeks after the completion of treatment</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HPV DNA Rate Decline</title>
        <description>With a two-sided type error rate of 5% and based on paired t test for means, there is 99% power to detect HPV DNA rate decline of 0.375 (effect size) within each arm (n=140). The HPV DNA rate for each group will be summarized using means and standard deviations.</description>
        <time_frame>Baseline to up to 2 weeks after the completion of treatment</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HPV DNA Copy Number</title>
        <description>Correlation between HPV DNA copy number and the nodal metabolic volume will be calculated using Spearman's correlation coefficient and R2, and the corresponding 95% CI will be provided.</description>
        <time_frame>Baseline to up to 2 weeks after the completion of treatment</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Variance for HPV DNA</title>
        <description>Univariable and multivariable cause specific analysis will be performed using the Cox proportional hazards model for rate of relapse.</description>
        <time_frame>Baseline to up to 2 weeks after the completion of treatment</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Weekly during treatment, at 1 and 3 months after end of treatment, then every 3 months from end of treatment for 2 years, every 6 months from end of treatment for 3 years, then annually until study completion. Maximum follow-up at time of reporting was 4.1 years.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>IMRT 6 Weeks + Cisplatin</title>
          <description>Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks&#xD;
IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
        </group>
        <group group_id="E2">
          <title>IMRT 5 Weeks</title>
          <description>IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-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="6" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Heart failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Esophagitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Enterocolitis infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck soft tissue necrosis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Pharyngeal mucositis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Pharyngolaryngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-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="152" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="147" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="147"/>
              </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="8" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hearing impaired</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="150" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="142" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="124" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="119" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="131" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="121" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="109" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="138" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="117" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions - Other</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Neck edema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="115" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="121" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations - Other</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Dermatitis radiation</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="113" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="109" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="118" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="87" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="119" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="101" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="81" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="69" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Trismus</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="142" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="132" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Pharyngeal mucositis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Voice alteration</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="147"/>
              </event>
              <event>
                <sub_title>Lymphedema</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="147"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Wendy Seiferheld</name_or_title>
      <organization>NRG Oncology</organization>
      <phone>215-574-3208</phone>
      <email>seiferheldw@gmail.com</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/NCT02254278
org study id: NRG-HN002
secondary id: NCI-2014-01279
secondary id: NRG-HN002
secondary id: NRG-HN002
secondary id: U10CA180868
nct id: NCT02254278
lead sponsor: 
collaborator: 
has dmc: Yes
This randomized phase II trial studies the side effects and how well modestly reduced-dose
      intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating
      patients with oropharyngeal cancer that has spread to other places in the body (advanced).
      Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy,
      such as cisplatin, work in different ways to stop the growth of tumor cells, either by
      killing the cells, by stopping them from dividing, or by stopping them from spreading. It is
      not yet known whether IMRT is more effective with or without cisplatin in treating patients
      with oropharyngeal cancer.
PRIMARY OBJECTIVES:

      -To select the arm(s) achieving a 2-year progression-free survival rate of >= 85% without
      unacceptable swallowing toxicity at 1 year.

      SECONDARY OBJECTIVES:

        -  To determine patterns of failure (locoregional relapse versus distant) and survival
           -(overall and progression-free) at 6 months and 2 years.

        -  To determine acute toxicity profiles at the end of radiation therapy and at 1 and 6
           months.

        -  To determine late toxicity profiles at 1 and 2 years.

        -  To determine patient-reported swallowing outcomes at 6 months and 1 and 2 years.

        -  To determine the predictive value of 12-14 week, post-treatment fludeoxyglucose F 18
           (FDG)-positron emission tomography (PET)/computed tomography (CT) for locoregional
           control and progression free survival (PFS) at 2 years.

        -  To determine the predictive value of blood and tissue biomarkers for disease outcomes at
           2 years.

        -  To determine swallowing recovery per videofluoroscopy imaging at 2 years.

      After completion of study treatment, patients are followed at 1 and 3 months then every 3
      months for 2 years, every 6 months for 3 years, and then annually thereafter.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)
time frame: From randomization to 2 years
description: Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.
measure: Percentage of Participants With Local-regional Failure
time frame: From randomization to 2 years
description: Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown > 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.
measure: Percentage of Participants With Distant Metastasis
time frame: From randomization to 2 years
description: Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.
measure: Percentage of Participants Alive
time frame: from randomization to 2 years
description: Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.
measure: Percentage of Participants With Grade 3+ Adverse Events
time frame: End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT
description: Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
measure: Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)
time frame: One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2
description: The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia.
measure: Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years
time frame: 3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2)
description: NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown > 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis.
measure: Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Detection Rate
time frame: Baseline to up to 2 weeks after the completion of treatment
description: With a two-sided type error rate of 5% and based on chi-squared test for proportions, there is a greater than 99% power to detect HPV DNA detection rate of 65% and 95% between the 2 groups (n=140 in each arm). The rate of detection for each group will be summarized based on binomial distributions and a 95% confidence intervals (CI) will be provided.
measure: HPV DNA Rate Decline
time frame: Baseline to up to 2 weeks after the completion of treatment
description: With a two-sided type error rate of 5% and based on paired t test for means, there is 99% power to detect HPV DNA rate decline of 0.375 (effect size) within each arm (n=140). The HPV DNA rate for each group will be summarized using means and standard deviations.
measure: HPV DNA Copy Number
time frame: Baseline to up to 2 weeks after the completion of treatment
description: Correlation between HPV DNA copy number and the nodal metabolic volume will be calculated using Spearman's correlation coefficient and R2, and the corresponding 95% CI will be provided.
measure: Variance for HPV DNA
time frame: Baseline to up to 2 weeks after the completion of treatment
description: Univariable and multivariable cause specific analysis will be performed using the Cox proportional hazards model for rate of relapse.
arm group label: IMRT 6 weeks + cisplatin
arm group type: Experimental
description: IMRT 6 weeks with concurrent cisplatin
arm group label: IMRT 5 weeks
arm group type: Experimental
description: IMRT 5 weeks
intervention type: Drug
intervention name: Cisplatin
description: 40 mg/m2 IV (intravenously) weekly for 6 weeks
arm group label: IMRT 6 weeks + cisplatin
intervention type: Radiation
intervention name: IMRT 6 weeks
description: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
arm group label: IMRT 6 weeks + cisplatin
other name: Intensity-Modulated Radiotherapy
intervention type: Radiation
intervention name: IMRT 5 weeks
description: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
arm group label: IMRT 5 weeks
other name: Intensity-Modulated Radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sue Yom
role: Principal Investigator
affiliation: NRG Oncology
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country: Canada
country: Ireland
country: Saudi Arabia
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Oropharyngeal Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Cisplatin
provided document: 
provided document: 
participant flow: 
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reported events: 
certain agreements: 
point of contact: 