<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/NCT02258659</url>
  </required_header>
  <id_info>
    <org_study_id>IRB14-0639</org_study_id>
    <secondary_id>NCI-2014-01867</secondary_id>
    <secondary_id>IRB14-0639</secondary_id>
    <secondary_id>P30CA014599</secondary_id>
    <nct_id>NCT02258659</nct_id>
  </id_info>
  <brief_title>Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer</brief_title>
  <acronym>OPTIMA</acronym>
  <official_title>An Exploratory Pilot Study of Nab-paclitaxel Based Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Patients With Stage III and IV HPV-Related Oropharyngeal Cancer - the OPTIMA HPV Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle&#xD;
      formulation) and carboplatin followed by response-based local therapy in treating patients&#xD;
      with stage III or IV human papillomavirus (HPV)-related oropharyngeal cancer. Drugs used in&#xD;
      chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin,&#xD;
      hydroxyurea, fluorouracil, paclitaxel, and cisplatin, work in different ways to stop the&#xD;
      growth of tumor cells, either by killing the cells, by stopping them from dividing, or by&#xD;
      stopping them spreading. Radiation therapy uses high energy x rays to kill tumor cells.&#xD;
      Giving nab-paclitaxel and carboplatin before chemoradiation may make the tumor smaller and&#xD;
      reduce the amount of chemotherapy and radiation therapy needed. Assigning chemotherapy and&#xD;
      radiation therapy based on response (response-based therapy) and giving patients who are&#xD;
      responding well lower doses of treatment may help reduce the occurrence of side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the 2-year progression-free survival (PFS).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Clinical complete response rate (nab-paclitaxel based induction, compared to European&#xD;
      Prospective Investigation into Cancer and Nutrition [EPIC] induction [paclitaxel based]).&#xD;
&#xD;
      II. Response rate (nab-paclitaxel based induction, compared to EPIC induction [paclitaxel&#xD;
      based]).&#xD;
&#xD;
      III. Proportion of patients with &gt;= 50% shrinkage by Response Evaluation Criteria In Solid&#xD;
      Tumors (RECIST) (nab-paclitaxel based induction, compared to EPIC induction, paclitaxel&#xD;
      based).&#xD;
&#xD;
      IV. Toxicity (nab-paclitaxel based induction, compared to EPIC induction [paclitaxel based]).&#xD;
&#xD;
      V. To assess swallowing function and speech at 6 months (mos) and 12 mos post therapy.&#xD;
&#xD;
      VI. To determine the rates of late toxicity with chemoradiation following surgery as&#xD;
      determined by xerostomia, dental decay, osteroradionecrosis, G-tube dependency, tracheostomy&#xD;
      placement and dysphagia.&#xD;
&#xD;
      VII. 2-year overall survival (OS) in patients treated on the Low-Risk, Intermediate-Risk Arm,&#xD;
      and High-Risk Arms.&#xD;
&#xD;
      VIII. 2-year PFS in patients treated on the Low-Risk, Intermediate-Risk Arm, and High-Risk&#xD;
      Arms - early and late toxicities.&#xD;
&#xD;
      IX. Evaluate need for post radiotherapy/chemoradiotherapy (RT/CRT) surgery on low- and&#xD;
      intermediate-risk arms based on response from induction chemotherapy.&#xD;
&#xD;
      X. Evaluate in a descriptive manner the role of transoral robotic surgery (TORS)&#xD;
      resection/lymph node dissection (LND) when integrated into a de-escalation trial.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate pathologic/histologic appearance of tumor after induction chemotherapy and&#xD;
      after CRT.&#xD;
&#xD;
      II. Translational research on blood and tissue samples. III. To profile tumors genetically&#xD;
      and immunologically in order to assess in a descriptive manner genetic or immunological&#xD;
      features characteristic of clinical behavior.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      INDUCTION CHEMOTHERAPY: All patients receive paclitaxel albumin-stabilized nanoparticle&#xD;
      formulation intravenously (IV) over 60 minutes on days 1, 8, and 15 and carboplatin IV over&#xD;
      30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of&#xD;
      disease progression or unacceptable toxicity.&#xD;
&#xD;
      Patients are then assigned to 1 of 3 treatment groups based on response to induction&#xD;
      chemotherapy.&#xD;
&#xD;
      GROUP A (LOW-DOSE ARM): Patients undergo radiation therapy once daily for 5 weeks.&#xD;
&#xD;
      GROUP B (INTERMEDIATE-DOSE ARM): Patients receive hydroxyurea orally (PO) twice daily (BID)&#xD;
      on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on&#xD;
      day 1. Patients also receive low-dose radiation therapy BID on days 1-5. Treatment repeats&#xD;
      every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      GROUP C (STANDARD-DOSE ARM): Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV&#xD;
      continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive&#xD;
      standard-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for up to 5&#xD;
      courses in the absence of disease progression or unacceptable toxicity.*&#xD;
&#xD;
      *NOTE: At the discretion of the principal investigator (PI), patients may receive cisplatin&#xD;
      IV over 1-3 hours every 3 weeks during radiation therapy instead of paclitaxel and undergo&#xD;
      daily radiation therapy.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 30 days, every 3 months for&#xD;
      1 year, every 6 months for 2 years, and then annually for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 22, 2014</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1</measure>
    <time_frame>Time from enrollment until disease progression or death from any cause, assessed at 2 years</time_frame>
    <description>If all patients are followed for two years, the PFS rate and confidence interval will be determined based on the exact binomial distribution. Otherwise, PFS will be estimated using the Kaplan-Meier method and a (large-sample) one-sided 90% confidence interval will be derived for the PFS rate at two years to test the non-inferiority hypothesis. Median PFS will be estimated as described in Brookmeyer and Crowley.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1</measure>
    <time_frame>Up to 8 weeks after completion of CRT</time_frame>
    <description>Pathologic response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Complete Response by Computerized Tomography (CT) &amp; Magnetic Resonance Imaging (MRI) Only</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Clinical response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From the date of registration to the date of death or date of last patient contact if censored, assessed up to 5 years</time_frame>
    <description>Overall survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific Survival</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Overall Cancer-specific survival rate. Patients dying from non-cancer related causes will be censored at the time of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of acute (mucositis, xerostomia, anorexia, weight loss, dermatitis and G-tube placement) toxicities will be estimated along with 95% confidence intervals. Toxicity criteria of the Common Toxicity Criteria (CTC) and the Radiation Therapy Oncology Group (RTOG) will be used to determine grades. General CTC grade definitions: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. For Mucous, 3 = Confluent fibrinous, mucositis / may include severe pain requiring narcotic; 4 = Ulceration, hemorrhage or necrosis. For neutropenia, 3 = Neutrophils 0.5 - &lt; 1.0; 4 = Neutrophils &lt; 0.5 or sepsis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of late-term (xerostomia, dental decay, osteroradionecrosis, G-tube dependency, speech abnormalities, tracheostomy placement and dysphagia) toxicities will be estimated along with 95% confidence intervals.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Histologic Appearance of Post-induction Tumor Tissue</measure>
    <time_frame>Up to 3 months post-treatment</time_frame>
    <description>Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.</description>
  </other_outcome>
  <other_outcome>
    <measure>Histologic Appearance of Post-CRT Tumor Tissue</measure>
    <time_frame>Up to 3 months post-treatment</time_frame>
    <description>Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Reactive T Cells</measure>
    <time_frame>Baseline to up to 2 months after radiation therapy</time_frame>
    <description>Changes in reactive T cells over time will be assessed using mixed effects models and simple paired t-tests.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Human Papilloma Virus Infection</condition>
  <condition>Stage III Squamous Cell Carcinoma of the Oropharynx</condition>
  <condition>Stage IVA Squamous Cell Carcinoma of the Oropharynx</condition>
  <condition>Stage IVB Squamous Cell Carcinoma of the Oropharynx</condition>
  <arm_group>
    <arm_group_label>Group A (radiation therapy alone)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo radiation therapy once daily for weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (combination chemotherapy, low-dose radiation therapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive low-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C (combination chemotherapy, high-dose radiation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive standard-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.*&#xD;
*NOTE: At the discretion of the PI, patients may receive cisplatin IV over 1-3 hours every 3 weeks during radiation therapy instead of paclitaxel and undergo daily radiation therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paclitaxel albumin-stabilized nanoparticle formulation</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Group A (radiation therapy alone)</arm_group_label>
    <arm_group_label>Group B (combination chemotherapy, low-dose radiation therapy)</arm_group_label>
    <arm_group_label>Group C (combination chemotherapy, high-dose radiation)</arm_group_label>
    <other_name>ABI-007</other_name>
    <other_name>nab paclitaxel</other_name>
    <other_name>nab-paclitaxel</other_name>
    <other_name>nanoparticle albumin-bound paclitaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>carboplatin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Group A (radiation therapy alone)</arm_group_label>
    <arm_group_label>Group B (combination chemotherapy, low-dose radiation therapy)</arm_group_label>
    <arm_group_label>Group C (combination chemotherapy, high-dose radiation)</arm_group_label>
    <other_name>Carboplat</other_name>
    <other_name>CBDCA</other_name>
    <other_name>JM-8</other_name>
    <other_name>Paraplat</other_name>
    <other_name>Paraplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>radiation therapy</intervention_name>
    <description>Undergo radiation therapy</description>
    <arm_group_label>Group A (radiation therapy alone)</arm_group_label>
    <arm_group_label>Group B (combination chemotherapy, low-dose radiation therapy)</arm_group_label>
    <arm_group_label>Group C (combination chemotherapy, high-dose radiation)</arm_group_label>
    <other_name>irradiation</other_name>
    <other_name>radiotherapy</other_name>
    <other_name>therapy, radiation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paclitaxel</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Group B (combination chemotherapy, low-dose radiation therapy)</arm_group_label>
    <arm_group_label>Group C (combination chemotherapy, high-dose radiation)</arm_group_label>
    <other_name>Anzatax</other_name>
    <other_name>Asotax</other_name>
    <other_name>TAX</other_name>
    <other_name>Taxol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fluorouracil</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Group B (combination chemotherapy, low-dose radiation therapy)</arm_group_label>
    <arm_group_label>Group C (combination chemotherapy, high-dose radiation)</arm_group_label>
    <other_name>5-fluorouracil</other_name>
    <other_name>5-Fluracil</other_name>
    <other_name>5-FU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>hydroxyurea</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Group B (combination chemotherapy, low-dose radiation therapy)</arm_group_label>
    <arm_group_label>Group C (combination chemotherapy, high-dose radiation)</arm_group_label>
    <other_name>HU</other_name>
    <other_name>HYD</other_name>
    <other_name>Hydrea</other_name>
    <other_name>Hydroxycarbamide</other_name>
    <other_name>Hydurea</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Group C (combination chemotherapy, high-dose radiation)</arm_group_label>
    <other_name>CACP</other_name>
    <other_name>CDDP</other_name>
    <other_name>CPDD</other_name>
    <other_name>DDP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Group A (radiation therapy alone)</arm_group_label>
    <arm_group_label>Group B (combination chemotherapy, low-dose radiation therapy)</arm_group_label>
    <arm_group_label>Group C (combination chemotherapy, high-dose radiation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>quality-of-life assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group A (radiation therapy alone)</arm_group_label>
    <arm_group_label>Group B (combination chemotherapy, low-dose radiation therapy)</arm_group_label>
    <arm_group_label>Group C (combination chemotherapy, high-dose radiation)</arm_group_label>
    <other_name>quality of life assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have pathologically confirmed HPV-positive squamous cell carcinoma&#xD;
&#xD;
          -  HPV testing must follow the following criteria&#xD;
&#xD;
               -  HPV testing using an E6/E7 based assay is preferred, and does not require any&#xD;
                  validation (e.g. HPV in situ hybridization [ISH] or HPV E6/E7 polymerase chain&#xD;
                  reaction [PCR])&#xD;
&#xD;
               -  For oropharyngeal tumors p16 immunohistochemistry (IHC) positivity is sufficient&#xD;
                  to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by&#xD;
                  Jordan/Lingen et al 2012); it is recommended that p16 IHC positivity is validated&#xD;
                  at a later point (during or after treatment) using an E6/E7 based test at the&#xD;
                  University of Chicago and provided slides will be used&#xD;
&#xD;
               -  For non-operative (OP) tumors accurate HPV testing (i.e. ISH, or E6/E7 based&#xD;
                  testing) is required for enrollment and treatment initiation&#xD;
&#xD;
          -  Availability of &gt;= 10 unstained 5 micron slides&#xD;
&#xD;
          -  Patients with American Joint Committee on Cancer (AJCC) (7th edition, 2010) nodal&#xD;
             stage N2 or N3 or a T4 primary tumor&#xD;
&#xD;
          -  The primary and nodal involvement must be assessable on clinical exam (mucosal and&#xD;
             lymph node exam)&#xD;
&#xD;
          -  The primary and nodal involvement must have been defined bi- or uni-dimensional&#xD;
             measurements measurable by RECIST&#xD;
&#xD;
          -  No previous radiation or chemotherapy for a head and neck cancer&#xD;
&#xD;
          -  No surgical resection for a head and neck cancer within 8 weeks of enrollment&#xD;
             (although lymph node biopsy including excision of an individual node with presence of&#xD;
             residual nodal disease, or surgical biopsy of the tumor is acceptable)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky &gt;= 70%)&#xD;
&#xD;
          -  Leukocytes &gt;= 3000/mm^3&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mm^3&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1,500&#xD;
&#xD;
          -  Hemoglobin &gt; 9.0 gm/dL&#xD;
&#xD;
          -  Albumin &gt; 2.9 gm/dL&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 mg/dl&#xD;
&#xD;
          -  Creatinine clearance &gt; 45 mL/min (or serum creatinine [SCr] =&lt; 1.5 mg/dL), normal&#xD;
             within 2 weeks prior to start of treatment&#xD;
&#xD;
          -  The standard Cockcroft and Gault formula or the measured glomerular filtration rate&#xD;
             must be used to calculate creatinine clearance (CrCl) for enrollment or dosing&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =&lt; 2.5 X upper&#xD;
             limit of normal (ULN)&#xD;
&#xD;
          -  Alkaline phosphatase =&lt; 2.5 X ULN&#xD;
&#xD;
          -  Patients must sign a study-specific informed consent form prior to study entry;&#xD;
             patients should have the ability to understand and the willingness to sign a written&#xD;
             informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unequivocal demonstration of distant metastases (M1 disease)&#xD;
&#xD;
          -  Intercurrent medical illnesses which would impair patient tolerance to therapy or&#xD;
             limit survival; including but not limited to ongoing or active infection,&#xD;
             immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction,&#xD;
             cardiomyopathy, unstable angina pectoris, cardiac arrhythmia or psychiatric&#xD;
             illness/social situations that would limit compliance&#xD;
&#xD;
          -  Pregnant and nursing women are excluded; men and women of child-bearing potential are&#xD;
             eligible but must consent to using effective contraception during therapy and for at&#xD;
             least 3 months after completing therapy; women with child-bearing potential must have&#xD;
             a negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test at&#xD;
             screening&#xD;
&#xD;
          -  Other coexisting malignancies or malignancies diagnosed within the previous 3 years no&#xD;
             evidence of disease for at least 3 years; exceptions to this include non-melanoma skin&#xD;
             cancer, cervical cancer in situ, well differentiated thyroid cancer or prostate&#xD;
             cancer; other cancers that per assessment of the PI are not prognosis limiting can be&#xD;
             allowed after review by the PI&#xD;
&#xD;
          -  Prior surgical therapy other than incisional or excisional biopsy and organ-sparing&#xD;
             procedures such as debulking of airway-compromising tumors or neck dissection in a&#xD;
             patient with an unknown primary tumor; residual tumor is required for enrollment on&#xD;
             study&#xD;
&#xD;
          -  Patients receiving other investigational agents&#xD;
&#xD;
          -  Peripheral neuropathy &gt;= grade 1&#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>Everett Vokes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <results_first_submitted>December 14, 2020</results_first_submitted>
  <results_first_submitted_qc>December 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 8, 2021</results_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</mesh_term>
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Papilloma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Hydroxyurea</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>May 18, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT02258659/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Single Arm</title>
          <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Arm</title>
          <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="62"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" lower_limit="54" upper_limit="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1</title>
        <description>If all patients are followed for two years, the PFS rate and confidence interval will be determined based on the exact binomial distribution. Otherwise, PFS will be estimated using the Kaplan-Meier method and a (large-sample) one-sided 90% confidence interval will be derived for the PFS rate at two years to test the non-inferiority hypothesis. Median PFS will be estimated as described in Brookmeyer and Crowley.</description>
        <time_frame>Time from enrollment until disease progression or death from any cause, assessed at 2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1</title>
          <description>If all patients are followed for two years, the PFS rate and confidence interval will be determined based on the exact binomial distribution. Otherwise, PFS will be estimated using the Kaplan-Meier method and a (large-sample) one-sided 90% confidence interval will be derived for the PFS rate at two years to test the non-inferiority hypothesis. Median PFS will be estimated as described in Brookmeyer and Crowley.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.5" lower_limit="88" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1</title>
        <description>Pathologic response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.</description>
        <time_frame>Up to 8 weeks after completion of CRT</time_frame>
        <population>Ten missing values</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1</title>
          <description>Pathologic response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.</description>
          <population>Ten missing values</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" lower_limit="79" upper_limit="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Complete Response by Computerized Tomography (CT) &amp; Magnetic Resonance Imaging (MRI) Only</title>
        <description>Clinical response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.</description>
        <time_frame>Up to 5 years</time_frame>
        <population>one missing value</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Complete Response by Computerized Tomography (CT) &amp; Magnetic Resonance Imaging (MRI) Only</title>
          <description>Clinical response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.</description>
          <population>one missing value</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>complete response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="5.8" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="68" upper_limit="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="5.8" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival rate</description>
        <time_frame>From the date of registration to the date of death or date of last patient contact if censored, assessed up to 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival rate</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" lower_limit="66" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cancer-specific Survival</title>
        <description>Overall Cancer-specific survival rate. Patients dying from non-cancer related causes will be censored at the time of death.</description>
        <time_frame>Up to 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
          </group>
        </group_list>
        <measure>
          <title>Cancer-specific Survival</title>
          <description>Overall Cancer-specific survival rate. Patients dying from non-cancer related causes will be censored at the time of death.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95" lower_limit="85" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement</title>
        <description>Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of acute (mucositis, xerostomia, anorexia, weight loss, dermatitis and G-tube placement) toxicities will be estimated along with 95% confidence intervals. Toxicity criteria of the Common Toxicity Criteria (CTC) and the Radiation Therapy Oncology Group (RTOG) will be used to determine grades. General CTC grade definitions: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. For Mucous, 3 = Confluent fibrinous, mucositis / may include severe pain requiring narcotic; 4 = Ulceration, hemorrhage or necrosis. For neutropenia, 3 = Neutrophils 0.5 - &lt; 1.0; 4 = Neutrophils &lt; 0.5 or sepsis.</description>
        <time_frame>Up to 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
          </group>
        </group_list>
        <measure>
          <title>Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement</title>
          <description>Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of acute (mucositis, xerostomia, anorexia, weight loss, dermatitis and G-tube placement) toxicities will be estimated along with 95% confidence intervals. Toxicity criteria of the Common Toxicity Criteria (CTC) and the Radiation Therapy Oncology Group (RTOG) will be used to determine grades. General CTC grade definitions: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. For Mucous, 3 = Confluent fibrinous, mucositis / may include severe pain requiring narcotic; 4 = Ulceration, hemorrhage or necrosis. For neutropenia, 3 = Neutrophils 0.5 - &lt; 1.0; 4 = Neutrophils &lt; 0.5 or sepsis.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 3+ mucositis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3+ dermatitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>grade 3+ neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>grade 3+ Anorexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia</title>
        <description>Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of late-term (xerostomia, dental decay, osteroradionecrosis, G-tube dependency, speech abnormalities, tracheostomy placement and dysphagia) toxicities will be estimated along with 95% confidence intervals.</description>
        <time_frame>Up to 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
          </group>
        </group_list>
        <measure>
          <title>Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia</title>
          <description>Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of late-term (xerostomia, dental decay, osteroradionecrosis, G-tube dependency, speech abnormalities, tracheostomy placement and dysphagia) toxicities will be estimated along with 95% confidence intervals.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>G-tube dependence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dysphagia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Histologic Appearance of Post-induction Tumor Tissue</title>
        <description>Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.</description>
        <time_frame>Up to 3 months post-treatment</time_frame>
        <population>zero analyzed because no data was collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
          </group>
        </group_list>
        <measure>
          <title>Histologic Appearance of Post-induction Tumor Tissue</title>
          <description>Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.</description>
          <population>zero analyzed because no data was collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Histologic Appearance of Post-CRT Tumor Tissue</title>
        <description>Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.</description>
        <time_frame>Up to 3 months post-treatment</time_frame>
        <population>zero analyzed because no data was collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
          </group>
        </group_list>
        <measure>
          <title>Histologic Appearance of Post-CRT Tumor Tissue</title>
          <description>Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.</description>
          <population>zero analyzed because no data was collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Changes in Reactive T Cells</title>
        <description>Changes in reactive T cells over time will be assessed using mixed effects models and simple paired t-tests.</description>
        <time_frame>Baseline to up to 2 months after radiation therapy</time_frame>
        <population>zero analyzed because no data was collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Reactive T Cells</title>
          <description>Changes in reactive T cells over time will be assessed using mixed effects models and simple paired t-tests.</description>
          <population>zero analyzed because no data was collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 5 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Single Arm</title>
          <description>Radiation therapy alone, combination chemotherapy with low-dose radiation therapy, or combination chemotherapy with high-dose radiation</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Eye disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Esophageal pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Neck edema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Dermatitis radiation</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Injury, poisoning and procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pharyngolaryngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Postnasal drip</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorder</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Skin ulceration</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphedema</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="62"/>
              </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>Dr. Everett Vokes</name_or_title>
      <organization>University of Chicago</organization>
      <phone>773-702-9306</phone>
      <email>evokes@medicine.bsd.uchicago.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/NCT02258659
org study id: IRB14-0639
secondary id: NCI-2014-01867
secondary id: IRB14-0639
secondary id: P30CA014599
nct id: NCT02258659
lead sponsor: 
collaborator: 
has dmc: Yes
This phase II trial studies nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle
      formulation) and carboplatin followed by response-based local therapy in treating patients
      with stage III or IV human papillomavirus (HPV)-related oropharyngeal cancer. Drugs used in
      chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin,
      hydroxyurea, fluorouracil, paclitaxel, and cisplatin, work in different ways to stop the
      growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
      stopping them spreading. Radiation therapy uses high energy x rays to kill tumor cells.
      Giving nab-paclitaxel and carboplatin before chemoradiation may make the tumor smaller and
      reduce the amount of chemotherapy and radiation therapy needed. Assigning chemotherapy and
      radiation therapy based on response (response-based therapy) and giving patients who are
      responding well lower doses of treatment may help reduce the occurrence of side effects.
PRIMARY OBJECTIVES:

      I. To determine the 2-year progression-free survival (PFS).

      SECONDARY OBJECTIVES:

      I. Clinical complete response rate (nab-paclitaxel based induction, compared to European
      Prospective Investigation into Cancer and Nutrition [EPIC] induction [paclitaxel based]).

      II. Response rate (nab-paclitaxel based induction, compared to EPIC induction [paclitaxel
      based]).

      III. Proportion of patients with >= 50% shrinkage by Response Evaluation Criteria In Solid
      Tumors (RECIST) (nab-paclitaxel based induction, compared to EPIC induction, paclitaxel
      based).

      IV. Toxicity (nab-paclitaxel based induction, compared to EPIC induction [paclitaxel based]).

      V. To assess swallowing function and speech at 6 months (mos) and 12 mos post therapy.

      VI. To determine the rates of late toxicity with chemoradiation following surgery as
      determined by xerostomia, dental decay, osteroradionecrosis, G-tube dependency, tracheostomy
      placement and dysphagia.

      VII. 2-year overall survival (OS) in patients treated on the Low-Risk, Intermediate-Risk Arm,
      and High-Risk Arms.

      VIII. 2-year PFS in patients treated on the Low-Risk, Intermediate-Risk Arm, and High-Risk
      Arms - early and late toxicities.

      IX. Evaluate need for post radiotherapy/chemoradiotherapy (RT/CRT) surgery on low- and
      intermediate-risk arms based on response from induction chemotherapy.

      X. Evaluate in a descriptive manner the role of transoral robotic surgery (TORS)
      resection/lymph node dissection (LND) when integrated into a de-escalation trial.

      TERTIARY OBJECTIVES:

      I. To evaluate pathologic/histologic appearance of tumor after induction chemotherapy and
      after CRT.

      II. Translational research on blood and tissue samples. III. To profile tumors genetically
      and immunologically in order to assess in a descriptive manner genetic or immunological
      features characteristic of clinical behavior.

      OUTLINE:

      INDUCTION CHEMOTHERAPY: All patients receive paclitaxel albumin-stabilized nanoparticle
      formulation intravenously (IV) over 60 minutes on days 1, 8, and 15 and carboplatin IV over
      30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of
      disease progression or unacceptable toxicity.

      Patients are then assigned to 1 of 3 treatment groups based on response to induction
      chemotherapy.

      GROUP A (LOW-DOSE ARM): Patients undergo radiation therapy once daily for 5 weeks.

      GROUP B (INTERMEDIATE-DOSE ARM): Patients receive hydroxyurea orally (PO) twice daily (BID)
      on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on
      day 1. Patients also receive low-dose radiation therapy BID on days 1-5. Treatment repeats
      every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.

      GROUP C (STANDARD-DOSE ARM): Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV
      continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive
      standard-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for up to 5
      courses in the absence of disease progression or unacceptable toxicity.*

      *NOTE: At the discretion of the principal investigator (PI), patients may receive cisplatin
      IV over 1-3 hours every 3 weeks during radiation therapy instead of paclitaxel and undergo
      daily radiation therapy.

      After completion of study treatment, patients are followed up for 30 days, every 3 months for
      1 year, every 6 months for 2 years, and then annually for 2 years.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1
time frame: Time from enrollment until disease progression or death from any cause, assessed at 2 years
description: If all patients are followed for two years, the PFS rate and confidence interval will be determined based on the exact binomial distribution. Otherwise, PFS will be estimated using the Kaplan-Meier method and a (large-sample) one-sided 90% confidence interval will be derived for the PFS rate at two years to test the non-inferiority hypothesis. Median PFS will be estimated as described in Brookmeyer and Crowley.
measure: Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1
time frame: Up to 8 weeks after completion of CRT
description: Pathologic response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.
measure: Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only
time frame: Up to 5 years
description: Clinical response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.
measure: Overall Survival
time frame: From the date of registration to the date of death or date of last patient contact if censored, assessed up to 5 years
description: Overall survival rate
measure: Cancer-specific Survival
time frame: Up to 5 years
description: Overall Cancer-specific survival rate. Patients dying from non-cancer related causes will be censored at the time of death.
measure: Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement
time frame: Up to 5 years
description: Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of acute (mucositis, xerostomia, anorexia, weight loss, dermatitis and G-tube placement) toxicities will be estimated along with 95% confidence intervals. Toxicity criteria of the Common Toxicity Criteria (CTC) and the Radiation Therapy Oncology Group (RTOG) will be used to determine grades. General CTC grade definitions: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. For Mucous, 3 = Confluent fibrinous, mucositis / may include severe pain requiring narcotic; 4 = Ulceration, hemorrhage or necrosis. For neutropenia, 3 = Neutrophils 0.5 - < 1.0; 4 = Neutrophils < 0.5 or sepsis.
measure: Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia
time frame: Up to 5 years
description: Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of late-term (xerostomia, dental decay, osteroradionecrosis, G-tube dependency, speech abnormalities, tracheostomy placement and dysphagia) toxicities will be estimated along with 95% confidence intervals.
measure: Histologic Appearance of Post-induction Tumor Tissue
time frame: Up to 3 months post-treatment
description: Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.
measure: Histologic Appearance of Post-CRT Tumor Tissue
time frame: Up to 3 months post-treatment
description: Results of pathology/histologic review of post induction biopsy specimens will be descriptive and summarize in tabular format.
measure: Changes in Reactive T Cells
time frame: Baseline to up to 2 months after radiation therapy
description: Changes in reactive T cells over time will be assessed using mixed effects models and simple paired t-tests.
arm group label: Group A (radiation therapy alone)
arm group type: Experimental
description: Patients undergo radiation therapy once daily for weeks.
arm group label: Group B (combination chemotherapy, low-dose radiation therapy)
arm group type: Experimental
description: Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive low-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity.
arm group label: Group C (combination chemotherapy, high-dose radiation)
arm group type: Experimental
description: Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive standard-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.*
*NOTE: At the discretion of the PI, patients may receive cisplatin IV over 1-3 hours every 3 weeks during radiation therapy instead of paclitaxel and undergo daily radiation therapy.
intervention type: Drug
intervention name: paclitaxel albumin-stabilized nanoparticle formulation
description: Given IV
arm group label: Group A (radiation therapy alone)
arm group label: Group B (combination chemotherapy, low-dose radiation therapy)
arm group label: Group C (combination chemotherapy, high-dose radiation)
other name: ABI-007
other name: nab paclitaxel
other name: nab-paclitaxel
other name: nanoparticle albumin-bound paclitaxel
intervention type: Drug
intervention name: carboplatin
description: Given IV
arm group label: Group A (radiation therapy alone)
arm group label: Group B (combination chemotherapy, low-dose radiation therapy)
arm group label: Group C (combination chemotherapy, high-dose radiation)
other name: Carboplat
other name: CBDCA
other name: JM-8
other name: Paraplat
other name: Paraplatin
intervention type: Radiation
intervention name: radiation therapy
description: Undergo radiation therapy
arm group label: Group A (radiation therapy alone)
arm group label: Group B (combination chemotherapy, low-dose radiation therapy)
arm group label: Group C (combination chemotherapy, high-dose radiation)
other name: irradiation
other name: radiotherapy
other name: therapy, radiation
intervention type: Drug
intervention name: paclitaxel
description: Given IV
arm group label: Group B (combination chemotherapy, low-dose radiation therapy)
arm group label: Group C (combination chemotherapy, high-dose radiation)
other name: Anzatax
other name: Asotax
other name: TAX
other name: Taxol
intervention type: Drug
intervention name: fluorouracil
description: Given IV
arm group label: Group B (combination chemotherapy, low-dose radiation therapy)
arm group label: Group C (combination chemotherapy, high-dose radiation)
other name: 5-fluorouracil
other name: 5-Fluracil
other name: 5-FU
intervention type: Drug
intervention name: hydroxyurea
description: Given PO
arm group label: Group B (combination chemotherapy, low-dose radiation therapy)
arm group label: Group C (combination chemotherapy, high-dose radiation)
other name: HU
other name: HYD
other name: Hydrea
other name: Hydroxycarbamide
other name: Hydurea
intervention type: Drug
intervention name: cisplatin
description: Given IV
arm group label: Group C (combination chemotherapy, high-dose radiation)
other name: CACP
other name: CDDP
other name: CPDD
other name: DDP
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Group A (radiation therapy alone)
arm group label: Group B (combination chemotherapy, low-dose radiation therapy)
arm group label: Group C (combination chemotherapy, high-dose radiation)
intervention type: Procedure
intervention name: quality-of-life assessment
description: Ancillary studies
arm group label: Group A (radiation therapy alone)
arm group label: Group B (combination chemotherapy, low-dose radiation therapy)
arm group label: Group C (combination chemotherapy, high-dose radiation)
other name: quality of life assessment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Everett Vokes, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Papillomavirus Infections
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Oropharyngeal Neoplasms
mesh term: Papilloma
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Carboplatin
mesh term: Fluorouracil
mesh term: Hydroxyurea
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 