<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/NCT02991456</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00076418</org_study_id>
    <nct_id>NCT02991456</nct_id>
  </id_info>
  <brief_title>Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide</brief_title>
  <official_title>Phase II Randomized Study to Evaluate Efficacy, Patient Satisfaction, and Compliance of the Oral Combination of Rolapitant (Varubi®) Plus Ondansetron vs. Ondansetron Monotherapy in Malignant Glioma Patients Receiving Radiotherapy (RT) and Concomitant Temozolomide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral&#xD;
      rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG)&#xD;
      patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a&#xD;
      randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the&#xD;
      prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT&#xD;
      and concomitant multi-dose TMZ.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All eligible subjects should receive a planned total dose of 54-60 gray (GY) of radiation and&#xD;
      75 mg/m2 of TMZ daily for a total of six weeks. Patients will be randomized to receive one of&#xD;
      two antiemetic treatment sequences: sequence A that involves administration of ondansetron&#xD;
      alone for 3 weeks followed by a single dose of rolapitant (day 22) plus daily ondansetron for&#xD;
      3 weeks or sequence B that involves a single dose of rolapitant (day 1) plus daily&#xD;
      ondansetron for 3 weeks followed by 3 weeks of daily ondansetron alone. The study has one&#xD;
      primary endpoint: complete response (CR) rate. Participation in this study may result in&#xD;
      reduced chemo-radiation induced nausea and vomiting, however, risks include the common side&#xD;
      effects of rolapitant including decreased appetite, neutropenia, dizziness, dyspepsia,&#xD;
      urinary tract infection, stomatitis, and anemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2017</start_date>
  <completion_date type="Actual">June 20, 2022</completion_date>
  <primary_completion_date type="Actual">May 9, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT)</measure>
    <time_frame>Weeks 1 and 2</time_frame>
    <description>The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes</measure>
    <time_frame>Weeks 1 and 2</time_frame>
    <description>The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone</measure>
    <time_frame>Weeks 1-6</time_frame>
    <description>The number of participants who prefer rolapitant plus ondansetron over ondansetron alone, as determined by response to the question with &quot;Which nausea medication regimen was I most satisfied with?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Week 3 Patient Satisfaction: Effectiveness</measure>
    <time_frame>Weeks 1-3</time_frame>
    <description>Mean effectiveness scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed from the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Week 3 Patient Satisfaction: Convenience</measure>
    <time_frame>Weeks 1-3</time_frame>
    <description>Mean convenience scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Week 3 Patient Satisfaction: Overall Satisfaction</measure>
    <time_frame>Weeks 1-3</time_frame>
    <description>Mean overall satisfaction scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Week 6 Patient Satisfaction: Effectiveness</measure>
    <time_frame>Weeks 4-6</time_frame>
    <description>Mean effectiveness scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed by summing the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Week 6 Patient Satisfaction: Convenience</measure>
    <time_frame>Weeks 4-6</time_frame>
    <description>Mean convenience scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Week 6 Patient Satisfaction: Overall Satisfaction</measure>
    <time_frame>Weeks 4-6</time_frame>
    <description>Mean overall satisfaction scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks</measure>
    <time_frame>Weeks 1 and 2</time_frame>
    <description>The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes</measure>
    <time_frame>Weeks 1 and 2</time_frame>
    <description>The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurses notes if MATs were missing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks</measure>
    <time_frame>Weeks 1 and 2</time_frame>
    <description>The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes</measure>
    <time_frame>Weeks 1 and 2</time_frame>
    <description>The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurse notes if MATS are missing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks</measure>
    <time_frame>Weeks 1-6</time_frame>
    <description>The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks</measure>
    <time_frame>Weeks 1-6</time_frame>
    <description>The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ondansetron Medication Compliance Weeks 1-3</measure>
    <time_frame>Weeks 1-3</time_frame>
    <description>Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 1-3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ondansetron Medication Compliance Weeks 4-6</measure>
    <time_frame>Weeks 4-6</time_frame>
    <description>Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 4-6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Grade 3, 4 or 5 Treatment-related Adverse Events</measure>
    <time_frame>8 weeks</time_frame>
    <description>The proportion of participants with grade 3, 4 or 5 adverse events (severe, life-threatening, or fatal) possibly, probably or definitely related to administration of Rolapitant or Ondansetron. Adverse events will be collected from start of treatment through the end of the two-week period following chemoradiation (or until 30 days after the last dose of rolapitant is given in Sequence A). CTCAE version 4 was used to grade adverse events.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Chemo-radiation Induced Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Sequence A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rolapitant</intervention_name>
    <description>single 180 mg dose by mouth</description>
    <arm_group_label>Sequence A</arm_group_label>
    <arm_group_label>Sequence B</arm_group_label>
    <other_name>Varubi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>8 mg by mouth daily</description>
    <arm_group_label>Sequence A</arm_group_label>
    <arm_group_label>Sequence B</arm_group_label>
    <other_name>Zofran</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically-confirmed, newly-diagnosed malignant glioma&#xD;
             (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligoastrocytoma,&#xD;
             anaplastic pleomorphic xanthoastrocytoma, or anaplastic oligodendroglioma) and are&#xD;
             scheduled to receive radiotherapy (for a total of 54-60 Gy) and concomitant daily&#xD;
             temozolomide therapy (at a dose of 75 mg/m^2 for one complete 6-week cycle).&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Karnofsky ≥ 60% or ECOG 0-2&#xD;
&#xD;
          -  Hematocrit &gt;29%, Absolute Neutrophil Count &gt;1,000 cells/mm^3, platelets &gt;100,000&#xD;
             cells/mm^3&#xD;
&#xD;
          -  Serum creatinine &lt;1.4 mg/dl, bilirubin &lt;1.5 times upper limit of normal (ULN)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) ≤ 2.5 x ULN. For subjects with known liver metastases&#xD;
             ≤ 5 x ULN, and alanine aminotransferase (ALT) ≤ 2.5 x ULN. For subjects with known&#xD;
             liver metastases ≤ 5 x ULN&#xD;
&#xD;
          -  For patients on higher than physiological level of corticosteroids, they must have&#xD;
             been on a stable dose for 1 week prior to initiating study drug, and the dose should&#xD;
             not be escalated over entry dose level, if clinically possible&#xD;
&#xD;
          -  Ability and willingness to give informed consent&#xD;
&#xD;
          -  Female patients of childbearing potential must have a negative pregnancy test at&#xD;
             Screening&#xD;
&#xD;
          -  Female patients of childbearing potential must agree to use an acceptable method of&#xD;
             birth control from the signing of informed consent and to continue its use during the&#xD;
             study and for at least 90 days after the final dose&#xD;
&#xD;
          -  Male patients must agree to use an acceptable form of birth control from study Day 1&#xD;
             through at least 90 days after the final dose&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-medications that may interact with rolapitant as reviewed by Duke Preston Robert&#xD;
             Tisch Brain Tumor investigator pharmacist.&#xD;
&#xD;
          -  Co-medications that are contraindicated in patients on rolapitant including pimozide,&#xD;
             thioridazine, carbamazepine, colchicine, dabigatran (Pradaxa), edoxaban (Savaysa),&#xD;
             fosphenytoin, metoprolol, phenobarbital, phenytoin, primidone, and warfarin&#xD;
&#xD;
          -  Inability or unwillingness to cooperate with the study procedures&#xD;
&#xD;
          -  Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to&#xD;
             the start of radiation therapy through the full course of radiation therapy is&#xD;
             prohibited, with the exception of the study drug. Corticosteroids will be allowed for&#xD;
             treatment of cerebral swelling&#xD;
&#xD;
          -  Previous participation in any clinical trial involving rolapitant&#xD;
&#xD;
          -  Any vomiting, retching, dry heaves, or clinically significant nausea (i.e., NCI Common&#xD;
             Toxicity Criteria version 4.0 grade 2-4 nausea) caused by any etiology in the 24 hrs.&#xD;
             preceding day 1 of the study intervention (ondansetron or ondansetron with rolapitant)&#xD;
             as scheduled to begin on day 1 of radiation and chemotherapy. Or a patient who has a&#xD;
             history of anticipatory nausea and vomiting.&#xD;
&#xD;
          -  Ongoing vomiting from any organic etiology&#xD;
&#xD;
          -  Received rolapitant within 21 days prior to study enrollment&#xD;
&#xD;
          -  Prior cancer chemotherapy or radiotherapy&#xD;
&#xD;
          -  Any current treatment, medical history, or uncontrolled condition, other than&#xD;
             malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or&#xD;
             psychiatric condition) that, in the opinion of the investigator, would confound the&#xD;
             results of the study or pose any unwarranted risk in administering study drug to the&#xD;
             subject&#xD;
&#xD;
          -  Patient has a known hypersensitivity to the administration of rolapitant or its&#xD;
             excipients&#xD;
&#xD;
          -  Patient has a history of severe renal or hepatic impairment, severe bone marrow&#xD;
             suppression, or systemic infection&#xD;
&#xD;
          -  Patient is a woman with a positive serum pregnancy test at Screening, is pregnant,&#xD;
             breast-feeding, or is planning to conceive children within the projected duration of&#xD;
             the study treatment&#xD;
&#xD;
          -  Patient has taken the following agents within the last 48 hours prior to the start of&#xD;
             treatment with study drug:&#xD;
&#xD;
          -  5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.).&#xD;
&#xD;
          -  Benzamides (metoclopramide, alizapride, etc.)&#xD;
&#xD;
          -  Domperidone&#xD;
&#xD;
          -  Cannabinoids&#xD;
&#xD;
          -  Natural Killer (NK)-1 antagonist (aprepitant)&#xD;
&#xD;
          -  Benzodiazepines (lorazepam, alprazolam, etc.)&#xD;
&#xD;
          -  herbal medications or preparations in doses designed to ameliorate nausea or emesis&#xD;
&#xD;
          -  Patient has taken phenothiazines (prochlorperazine, fluphenazine, perphenazine,&#xD;
             thiethylperazine, chlorpromazine, etc.) for any indication within the last 48 hours&#xD;
             prior to the start of treatment with study drug&#xD;
&#xD;
          -  Palonosetron is not permitted within 7 days prior to administration of investigational&#xD;
             product&#xD;
&#xD;
          -  Patient must not have been dosed with a test drug or blinded study drug in another&#xD;
             investigational study within 30 days or 5 half-lives of the biologic activity of the&#xD;
             test drug, whichever is longer, before the time of first study dose&#xD;
&#xD;
          -  Patient who is receiving investigational agent(s) as part of another clinical study at&#xD;
             the time of screening or who anticipates receiving investigational agent(s) during&#xD;
             their scheduled radiotherapy and concomitant daily temozolomide therapy (Any exception&#xD;
             to this criteria will be noted in a study Memo to File)&#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>Mary Lou Affronti, DNP, RN, ANP, MHSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Preston Robert Tisch Brain Tumor Center at Duke</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Preston Robert Tisch Brain Tumor Center at Duke</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cancer.duke.edu/btc/</url>
    <description>The Preston Robert Tisch Brain Tumor Center at Duke</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <results_first_submitted>May 9, 2023</results_first_submitted>
  <results_first_submitted_qc>July 10, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 11, 2023</results_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>malignant glioma</keyword>
  <keyword>temozolomide</keyword>
  <keyword>temodar</keyword>
  <keyword>radiation</keyword>
  <keyword>emesis</keyword>
  <keyword>nausea</keyword>
  <keyword>vomiting</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>Affronti</keyword>
  <keyword>Peters</keyword>
  <keyword>00076418</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</mesh_term>
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ondansetron</mesh_term>
    <mesh_term>Rolapitant</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>February 18, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT02991456/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sequence A</title>
          <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
        </group>
        <group group_id="P2">
          <title>Sequence B</title>
          <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sequence A</title>
          <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
        </group>
        <group group_id="B2">
          <title>Sequence B</title>
          <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</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="25"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.56" spread="13.99"/>
                    <measurement group_id="B2" value="52.78" spread="13.95"/>
                    <measurement group_id="B3" value="52.67" spread="13.82"/>
                  </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="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="46"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT)</title>
        <description>The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
        <time_frame>Weeks 1 and 2</time_frame>
        <population>Four participants in each group did not complete MATs for the first two weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT)</title>
          <description>The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
          <population>Four participants in each group did not complete MATs for the first two weeks.</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5717"/>
                    <measurement group_id="O2" value="0.7368"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.2734</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes</title>
        <description>The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing.</description>
        <time_frame>Weeks 1 and 2</time_frame>
        <population>Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes</title>
          <description>The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing.</description>
          <population>Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants.</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6000"/>
                    <measurement group_id="O2" value="0.6522"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.7091</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone</title>
        <description>The number of participants who prefer rolapitant plus ondansetron over ondansetron alone, as determined by response to the question with &quot;Which nausea medication regimen was I most satisfied with?&quot;</description>
        <time_frame>Weeks 1-6</time_frame>
        <population>Participants who provided treatment preference data.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A and Sequence B</title>
            <description>Sequence A: Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Sequence B: Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone</title>
          <description>The number of participants who prefer rolapitant plus ondansetron over ondansetron alone, as determined by response to the question with &quot;Which nausea medication regimen was I most satisfied with?&quot;</description>
          <population>Participants who provided treatment preference data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Rolapitant + Ondansetron</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ondansetron alone</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Preference</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>This was tested as patients who preferred rolapitant + ondansetron vs. patients who did not prefer rolapitant + ondansetron. Patients who reported no preference and preference to Ondansetron were combined.</non_inferiority_desc>
            <p_value>0.0004</p_value>
            <method>Exact Binomial</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Three outcomes tested by sequence.</non_inferiority_desc>
            <p_value>0.5207</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Week 3 Patient Satisfaction: Effectiveness</title>
        <description>Mean effectiveness scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed from the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.</description>
        <time_frame>Weeks 1-3</time_frame>
        <population>Participants who responded to at least two of the TSQM-9 questions for the effectiveness subscale at week 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Week 3 Patient Satisfaction: Effectiveness</title>
          <description>Mean effectiveness scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed from the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.</description>
          <population>Participants who responded to at least two of the TSQM-9 questions for the effectiveness subscale at week 3.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.60" spread="20.14"/>
                    <measurement group_id="O2" value="94.44" spread="11.11"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Effectiveness during weeks 1-3 between sequences.</non_inferiority_desc>
            <p_value>0.0406</p_value>
            <method>t-test, 1 sided</method>
            <method_desc>T-test using the Satterthwaite method for unequal variances.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Week 3 Patient Satisfaction: Convenience</title>
        <description>Mean convenience scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.</description>
        <time_frame>Weeks 1-3</time_frame>
        <population>Participants who responded to at least two of the TSQM-9 questions for the convenience subscale at week 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Week 3 Patient Satisfaction: Convenience</title>
          <description>Mean convenience scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.</description>
          <population>Participants who responded to at least two of the TSQM-9 questions for the convenience subscale at week 3.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.71" spread="15.57"/>
                    <measurement group_id="O2" value="94.15" spread="10.05"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Convenience during weeks 1-3 between sequences.</non_inferiority_desc>
            <p_value>0.0541</p_value>
            <method>t-test, 1 sided</method>
            <method_desc>T-test using the pooled method for equal variances.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Week 3 Patient Satisfaction: Overall Satisfaction</title>
        <description>Mean overall satisfaction scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.</description>
        <time_frame>Weeks 1-3</time_frame>
        <population>Participants who responded to at least two of the TSQM-9 questions for the overall satisfaction subscale at week 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Week 3 Patient Satisfaction: Overall Satisfaction</title>
          <description>Mean overall satisfaction scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.</description>
          <population>Participants who responded to at least two of the TSQM-9 questions for the overall satisfaction subscale at week 3.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.88" spread="17.69"/>
                    <measurement group_id="O2" value="90.94" spread="13.38"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Overall satisfaction during weeks 1-3 between sequences.</non_inferiority_desc>
            <p_value>0.0781</p_value>
            <method>t-test, 1 sided</method>
            <method_desc>T-test using the pooled method for equal variances.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Week 6 Patient Satisfaction: Effectiveness</title>
        <description>Mean effectiveness scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed by summing the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.</description>
        <time_frame>Weeks 4-6</time_frame>
        <population>Participants who responded to at least two of the TSQM-9 questions for the effectiveness subscale at week 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Week 6 Patient Satisfaction: Effectiveness</title>
          <description>Mean effectiveness scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed by summing the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.</description>
          <population>Participants who responded to at least two of the TSQM-9 questions for the effectiveness subscale at week 6.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.89" spread="17.28"/>
                    <measurement group_id="O2" value="88.27" spread="15.23"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Effectiveness during weeks 4-6 between sequences.</non_inferiority_desc>
            <p_value>0.4146</p_value>
            <method>t-test, 1 sided</method>
            <method_desc>T-test using the pooled method for equal variances.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Week 6 Patient Satisfaction: Convenience</title>
        <description>Mean convenience scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.</description>
        <time_frame>Weeks 4-6</time_frame>
        <population>Participants who responded to at least two of the TSQM-9 questions for the convenience subscale at week 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Week 6 Patient Satisfaction: Convenience</title>
          <description>Mean convenience scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.</description>
          <population>Participants who responded to at least two of the TSQM-9 questions for the convenience subscale at week 6.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.11" spread="16.07"/>
                    <measurement group_id="O2" value="91.98" spread="12.53"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Convenience during weeks 4-6 between sequences.</non_inferiority_desc>
            <p_value>0.2214</p_value>
            <method>t-test, 1 sided</method>
            <method_desc>T-test using the pooled method for equal variances.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Week 6 Patient Satisfaction: Overall Satisfaction</title>
        <description>Mean overall satisfaction scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.</description>
        <time_frame>Weeks 4-6</time_frame>
        <population>Participants who responded to at least two of the TSQM-9 questions for the overall satisfaction subscale at week 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Week 6 Patient Satisfaction: Overall Satisfaction</title>
          <description>Mean overall satisfaction scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.</description>
          <population>Participants who responded to at least two of the TSQM-9 questions for the overall satisfaction subscale at week 6.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.39" spread="21.16"/>
                    <measurement group_id="O2" value="88.58" spread="12.12"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Overall satisfaction during weeks 4-6 between sequences.</non_inferiority_desc>
            <p_value>0.2028</p_value>
            <method>t-test, 1 sided</method>
            <method_desc>T-test using the Satterthwaite method for unequal variances.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks</title>
        <description>The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
        <time_frame>Weeks 1 and 2</time_frame>
        <population>Participants who completed MATs for the first two weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks</title>
          <description>The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
          <population>Participants who completed MATs for the first two weeks.</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6160"/>
                    <measurement group_id="O2" value="0.6842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes</title>
        <description>The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurses notes if MATs were missing.</description>
        <time_frame>Weeks 1 and 2</time_frame>
        <population>Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes</title>
          <description>The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurses notes if MATs were missing.</description>
          <population>Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants.</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6000"/>
                    <measurement group_id="O2" value="0.6087"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks</title>
        <description>The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
        <time_frame>Weeks 1 and 2</time_frame>
        <population>Participants who completed MATs for the first two weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks</title>
          <description>The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
          <population>Participants who completed MATs for the first two weeks.</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8095"/>
                    <measurement group_id="O2" value="1.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes</title>
        <description>The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurse notes if MATS are missing.</description>
        <time_frame>Weeks 1 and 2</time_frame>
        <population>Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes</title>
          <description>The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurse notes if MATS are missing.</description>
          <population>Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants.</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8000"/>
                    <measurement group_id="O2" value="0.9565"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks</title>
        <description>The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
        <time_frame>Weeks 1-6</time_frame>
        <population>Participants who completed MATs for six weeks and complied with treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks</title>
          <description>The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
          <population>Participants who completed MATs for six weeks and complied with treatment.</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4737"/>
                    <measurement group_id="O2" value="0.4737"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks</title>
        <description>The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
        <time_frame>Weeks 1-6</time_frame>
        <population>Data not collected on 10 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks</title>
          <description>The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).</description>
          <population>Data not collected on 10 participants.</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7368"/>
                    <measurement group_id="O2" value="0.8947"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ondansetron Medication Compliance Weeks 1-3</title>
        <description>Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 1-3.</description>
        <time_frame>Weeks 1-3</time_frame>
        <population>Participants who remained on study and returned medication logs.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Ondansetron Medication Compliance Weeks 1-3</title>
          <description>Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 1-3.</description>
          <population>Participants who remained on study and returned medication logs.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.30"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ondansetron Medication Compliance Weeks 4-6</title>
        <description>Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 4-6.</description>
        <time_frame>Weeks 4-6</time_frame>
        <population>Participants who remained on study without schedule changes and returned medication logs.</population>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Ondansetron Medication Compliance Weeks 4-6</title>
          <description>Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 4-6.</description>
          <population>Participants who remained on study without schedule changes and returned medication logs.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="95.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Grade 3, 4 or 5 Treatment-related Adverse Events</title>
        <description>The proportion of participants with grade 3, 4 or 5 adverse events (severe, life-threatening, or fatal) possibly, probably or definitely related to administration of Rolapitant or Ondansetron. Adverse events will be collected from start of treatment through the end of the two-week period following chemoradiation (or until 30 days after the last dose of rolapitant is given in Sequence A). CTCAE version 4 was used to grade adverse events.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Sequence B</title>
            <description>Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Grade 3, 4 or 5 Treatment-related Adverse Events</title>
          <description>The proportion of participants with grade 3, 4 or 5 adverse events (severe, life-threatening, or fatal) possibly, probably or definitely related to administration of Rolapitant or Ondansetron. Adverse events will be collected from start of treatment through the end of the two-week period following chemoradiation (or until 30 days after the last dose of rolapitant is given in Sequence A). CTCAE version 4 was used to grade adverse events.</description>
          <units>proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Period 1 Rolapitant + Ondansetron</title>
          <description>Weeks 1-3&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
        </group>
        <group group_id="E2">
          <title>Period 1 Ondansetron</title>
          <description>Weeks 1-3&#xD;
Ondansetron: 8 mg by mouth daily</description>
        </group>
        <group group_id="E3">
          <title>Period 2 Rolapitant + Ondansetron</title>
          <description>Weeks 4-6&#xD;
Rolapitant: single 180 mg dose by mouth&#xD;
Ondansetron: 8 mg by mouth daily</description>
        </group>
        <group group_id="E4">
          <title>Period 2 Ondansetron</title>
          <description>Weeks 4-6&#xD;
Ondansetron: 8 mg by mouth daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal calculi</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Other, Specify: &quot;muffling&quot; in right ear</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Other, Specify: ear fullness/muffling, hard to hear in both ears</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred Vision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Other, Specify: impaired vision, right eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Other, Specify: right eye inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Floaters</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="23"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="23"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema Face</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Edema Limbs</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="23"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Other, Unspecified</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Other, Specify: constant feeling of being cold</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Injection Site Reaction</sub_title>
                <counts group_id="E1" events="7" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="6" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Neck Edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Other, Specify: oral fungal infection on tongue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Mucosal Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Otitis Externa</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Dermatitis Radiation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Other, Specify: blurred vision preventing reading, d/t radiation mask placement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Other, Specify: dermatitis radiation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Other, Specify: swollen eyelids impeding eye opening, d/t radiation mask placement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Alkaline Phosphatase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Creatinine Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Lymphocyte Count Decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="16" subjects_affected="9" subjects_at_risk="22"/>
                <counts group_id="E4" events="10" subjects_affected="7" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Neutrophil Count Decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="11" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E4" events="11" subjects_affected="5" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>White Blood Cell Decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="23"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E4" events="7" subjects_affected="4" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Other, Specify: temporomandibular joint inflammation causing nausea while chewing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Dysphasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Memory Impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pyramidal Tract Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Bullous Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Rash Maculo-Papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Other, Specify: &quot;bruising left hand from fall&quot;</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>James Herndon II, Ph.D.</name_or_title>
      <organization>Duke University</organization>
      <phone>919-668-8145</phone>
      <email>james.herndon@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02991456
org study id: Pro00076418
nct id: NCT02991456
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral
      rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG)
      patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a
      randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the
      prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT
      and concomitant multi-dose TMZ.
All eligible subjects should receive a planned total dose of 54-60 gray (GY) of radiation and
      75 mg/m2 of TMZ daily for a total of six weeks. Patients will be randomized to receive one of
      two antiemetic treatment sequences: sequence A that involves administration of ondansetron
      alone for 3 weeks followed by a single dose of rolapitant (day 22) plus daily ondansetron for
      3 weeks or sequence B that involves a single dose of rolapitant (day 1) plus daily
      ondansetron for 3 weeks followed by 3 weeks of daily ondansetron alone. The study has one
      primary endpoint: complete response (CR) rate. Participation in this study may result in
      reduced chemo-radiation induced nausea and vomiting, however, risks include the common side
      effects of rolapitant including decreased appetite, neutropenia, dizziness, dyspepsia,
      urinary tract infection, stomatitis, and anemia.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT)
time frame: Weeks 1 and 2
description: The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
measure: Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes
time frame: Weeks 1 and 2
description: The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing.
measure: Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone
time frame: Weeks 1-6
description: The number of participants who prefer rolapitant plus ondansetron over ondansetron alone, as determined by response to the question with "Which nausea medication regimen was I most satisfied with?"
measure: Week 3 Patient Satisfaction: Effectiveness
time frame: Weeks 1-3
description: Mean effectiveness scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed from the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.
measure: Week 3 Patient Satisfaction: Convenience
time frame: Weeks 1-3
description: Mean convenience scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.
measure: Week 3 Patient Satisfaction: Overall Satisfaction
time frame: Weeks 1-3
description: Mean overall satisfaction scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.
measure: Week 6 Patient Satisfaction: Effectiveness
time frame: Weeks 4-6
description: Mean effectiveness scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed by summing the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.
measure: Week 6 Patient Satisfaction: Convenience
time frame: Weeks 4-6
description: Mean convenience scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.
measure: Week 6 Patient Satisfaction: Overall Satisfaction
time frame: Weeks 4-6
description: Mean overall satisfaction scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.
measure: Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks
time frame: Weeks 1 and 2
description: The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
measure: Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes
time frame: Weeks 1 and 2
description: The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurses notes if MATs were missing.
measure: Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks
time frame: Weeks 1 and 2
description: The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
measure: Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes
time frame: Weeks 1 and 2
description: The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurse notes if MATS are missing.
measure: Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks
time frame: Weeks 1-6
description: The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
measure: Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks
time frame: Weeks 1-6
description: The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
measure: Ondansetron Medication Compliance Weeks 1-3
time frame: Weeks 1-3
description: Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 1-3.
measure: Ondansetron Medication Compliance Weeks 4-6
time frame: Weeks 4-6
description: Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 4-6.
measure: Proportion of Participants With Grade 3, 4 or 5 Treatment-related Adverse Events
time frame: 8 weeks
description: The proportion of participants with grade 3, 4 or 5 adverse events (severe, life-threatening, or fatal) possibly, probably or definitely related to administration of Rolapitant or Ondansetron. Adverse events will be collected from start of treatment through the end of the two-week period following chemoradiation (or until 30 days after the last dose of rolapitant is given in Sequence A). CTCAE version 4 was used to grade adverse events.
arm group label: Sequence A
arm group type: Active Comparator
description: Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
arm group label: Sequence B
arm group type: Active Comparator
description: Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
intervention type: Drug
intervention name: Rolapitant
description: single 180 mg dose by mouth
arm group label: Sequence A
arm group label: Sequence B
other name: Varubi
intervention type: Drug
intervention name: Ondansetron
description: 8 mg by mouth daily
arm group label: Sequence A
arm group label: Sequence B
other name: Zofran
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mary Lou Affronti, DNP, RN, ANP, MHSc
role: Principal Investigator
affiliation: The Preston Robert Tisch Brain Tumor Center at Duke
facility: 
country: United States
url: http://www.cancer.duke.edu/btc/
description: The Preston Robert Tisch Brain Tumor Center at Duke
responsible party type: Sponsor
mesh term: Glioma
mesh term: Nausea
mesh term: Vomiting
mesh term: Ondansetron
mesh term: Rolapitant
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 