<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/NCT01706939</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 12-1050</org_study_id>
    <nct_id>NCT01706939</nct_id>
  </id_info>
  <brief_title>The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer</brief_title>
  <official_title>The Quarterback Trial: A Randomized Phase III Clinical Trial Comparing Reduced and Standard Radiation Therapy Doses for Locally Advanced HPV Positive Oropharynx Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Biodesign Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This trial aims to directly compare a reduced radiation dose to the standard of care in&#xD;
      HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two&#xD;
      groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are&#xD;
      non-inferior to standard dose CRT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized Phase III study comparing two doses of definitive radiation therapy&#xD;
      given with induction and concurrent chemotherapy in HPV-positive oropharynx, unknown primary&#xD;
      or nasopharynx cancer. Eligible, consented and registered patients will receive three cycles&#xD;
      of Docetaxel Cisplatin and 5-FU (TPF) induction chemotherapy. After 3 cycles, the patients&#xD;
      will be assessed for clinical, radiographic and pathologic response to TPF. Patients with a&#xD;
      clinical or radiographic CR or PR will be randomized on the second phase of this study, where&#xD;
      patients will undergo a 2:1 randomization to reduced (5600 cGy) or standard (7000 cGy) dose&#xD;
      radiotherapy with weekly Carboplatin. Patients not meeting the response criteria will be&#xD;
      treated with standard dose CRT. Patients not completing 3 cycles TPF for reasons of toxicity,&#xD;
      progressive disease, choice, or other medical necessity will be treated with standard dose&#xD;
      CRT or surgery depending on their primary site and overall medical condition and followed for&#xD;
      survival. Toxicity will be assessed by Symptom scores, QOL and SAE monitoring. The primary&#xD;
      end point of the trial is equivalent local regional control and PFS at 3 years. Patients will&#xD;
      be followed for 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2012</start_date>
  <completion_date type="Anticipated">May 1, 2035</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Progression Free Survival (PFS)</measure>
    <time_frame>at 3 and 5 years</time_frame>
    <description>Progression free survival (PFS) at 5 years in patients with advanced HPV related oropharynx cancer, nasopharynx cancer or unknown primary treated with reduced or standard dose radiation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Local-regional Control</measure>
    <time_frame>at 3 years</time_frame>
    <description>Local-regional control (LRC) at 3 years in patients with advanced HPV related oropharynx cancer or unknown primary treated with reduced or standard dose radiation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Overall Survival at 5 Years</measure>
    <time_frame>at 5 years</time_frame>
    <description>Overall Survival (OS) 5 years treated with reduced or standard dose CRT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT)</measure>
    <time_frame>at 5 years</time_frame>
    <description>Number of participants with acute toxicity treated with reduced or standard dose CRT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers Predictive of Failure</measure>
    <time_frame>at 5 years</time_frame>
    <description>To determine biomarkers predictive of failure with either reduced or standard dose radiotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival at 15 Years</measure>
    <time_frame>at 15 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MD Anderson Dysphagia Inventory (MDADI) From Baseline</measure>
    <time_frame>Baseline and 5 years</time_frame>
    <description>MDADI is a questionnaire of 20 questions and contains a global subscale, and three other categories of questions (emotional, functional, and physical). The scores are summed and a mean score is calculated. This mean score was multiplied by 20 to obtain a score, with a range of 0 (extremely low functioning) to 100 (high functioning). Thus, a higher MDADI score represented better day-to-day functioning and better QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS)</measure>
    <time_frame>Baseline and 5 years</time_frame>
    <description>MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS) MDASI Head and Neck is a site-specific MDASI module which includes the core MDASI 13 symptom severity items (SS) and 6 symptom interference items (SI), alongside 9 items relevant to head and neck cancer. The scores are summed and a mean score is calculated on a scale of 0 (low severity or interference) to 10 (high severity or complete interference). In order to calculate the mean score, a majority of the subscale's items must have been completed.&#xD;
A lower or negative score reflects a better quality of life compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Xerostomia Questionnaire (XQ)</measure>
    <time_frame>Baseline and 5 years</time_frame>
    <description>XQ is a nine questions survey developed specifically for xerostomia symptoms. The scores are summed and a mean score is calculated on a scale of 0 (low xerostomia interference) to 10 (high xerostomia interference). A lower or negative score reflects a better quality of life compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in European Organization for Research and Treatment of Cancer Questionnaire for Head and Neck (EORTC HN)</measure>
    <time_frame>Baseline and 5 years</time_frame>
    <description>The EORTC Head and Neck module was specifically designed and validated for head and neck cancer patients. This 35-item questionnaire contains 7 symptom scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality), 6 single-item scales (difficulties of teeth, mouth opening, dry mouth, sticky saliva, coughing, and feeling ill), and 5 items about the additional use of pain medicine, nutritional supplements, and feeding tube and changes in body weight. All items were transformed to scales from 0 to 100, and divided into respective sub-scores of global health (GHS), functional (FS), and symptom scale (SS). Subscales from 0-100. A high score on global health and functional scale represents a better level of functioning, whereas a high score on a symptom scale and head and neck module indicates more severe symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Squamous Cell Carcinomas</condition>
  <arm_group>
    <arm_group_label>Reduced Dose Radiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Dose Radiation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Reduced Dose Radiation</intervention_name>
    <description>Reduced Dose Radiation (5600 cGy) dose radiotherapy</description>
    <arm_group_label>Reduced Dose Radiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Standard Dose Radiation</intervention_name>
    <description>Standard Dose Radiation (7000 cGy) dose radiotherapy</description>
    <arm_group_label>Standard Dose Radiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Day 1, every 7 days ( + 2 days)</description>
    <arm_group_label>Reduced Dose Radiation</arm_group_label>
    <arm_group_label>Standard Dose Radiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have histologically or cytologically confirmed squamous cell&#xD;
             carcinoma of the oropharynx, unknown primary, or nasopharynx that is HPV positive as&#xD;
             determined by PCR and p16 positive as determined by IHC. Tissue from the primary site&#xD;
             must be available for biomarker studies. PCR and IHC must be performed in the central&#xD;
             laboratory (Zhang, MSSM)&#xD;
&#xD;
          -  Stage 3 or 4 disease without evidence of distant metastases.&#xD;
&#xD;
          -  At least one clinically evaluable or uni- or bi-dimensionally measurable lesion by&#xD;
             RECIST 1.1 criteria.&#xD;
&#xD;
          -  Age &gt; 18 years.&#xD;
&#xD;
          -  No previous surgery, radiation therapy or chemotherapy for SSCHN (other than biopsy or&#xD;
             tonsillectomy) is allowed at time of study entry.&#xD;
&#xD;
          -  ECOG performance status of 0 or 1.&#xD;
&#xD;
          -  No active alcohol addiction (as assessed by medical caregiver and defined as at least&#xD;
             6 months without activity).&#xD;
&#xD;
          -  Participants must have adequate bone marrow, hepatic and renal functions as defined in&#xD;
             the protocol.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
          -  Patients with Gilbert's Disease and absent hepatic pathology by history and clinical&#xD;
             assessment maybe treated on study with bilirubins &gt; the ULN for the institution if&#xD;
             other liver function studies are within the normal range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding women, or women and men of childbearing potential not&#xD;
             willing to use adequate contraception while on treatment and for at least 3 months&#xD;
             thereafter.&#xD;
&#xD;
          -  Previous or current malignancies at other sites, with the exception of adequately&#xD;
             treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin,&#xD;
             thyroid cancer, or other cancer curatively treated by surgery and with no current&#xD;
             evidence of disease for at least 5 years.&#xD;
&#xD;
          -  Symptomatic peripheral neuropathy ≥ grade 2 by NCI Common Terminology Criteria&#xD;
             (NCI-CTC) version 4.&#xD;
&#xD;
          -  Symptomatic altered hearing &gt; grade 2 by NCI-CTCv4 criteria.&#xD;
&#xD;
          -  Other serious illnesses or medical conditions including but not limited to:&#xD;
&#xD;
               1. Unstable cardiac disease despite treatment, myocardial infarction within 6 months&#xD;
                  prior to study entry&#xD;
&#xD;
               2. History of significant neurologic or psychiatric disorders including dementia or&#xD;
                  seizures&#xD;
&#xD;
               3. Active clinically significant uncontrolled infection&#xD;
&#xD;
               4. Active peptic ulcer disease defined as unhealed or clinically active&#xD;
&#xD;
               5. Hypercalcemia&#xD;
&#xD;
               6. Active drug addiction including alcohol, cocaine or intravenous drug use defined&#xD;
                  as occurring within the 6 months preceding diagnosis&#xD;
&#xD;
               7. Chronic Obstructive Pulmonary Disease, defined as being associated with a&#xD;
                  hospitalization for pneumonia or respiratory decompensation within 12 months of&#xD;
                  diagnosis. This does not include obstruction from tumor&#xD;
&#xD;
               8. Autoimmune disease requiring therapy, prior organ transplant, or HIV infection&#xD;
&#xD;
               9. Interstitial lung disease&#xD;
&#xD;
              10. Hepatitis C (test required)&#xD;
&#xD;
          -  Patients that have experienced an involuntary weight loss of more than 25% of their&#xD;
             body weight in the 2 months preceding study entry.&#xD;
&#xD;
          -  Concurrent treatment with any other anticancer therapy.&#xD;
&#xD;
          -  Participation in an investigational therapeutic drug trial within 30 days of study&#xD;
             entry.&#xD;
&#xD;
          -  Active smoking within the past 20 years with a cumulative Pack Year history of &gt; 20&#xD;
             Pack Years or active smoking (Defined as &gt; 1 cigarette per day) within the last 2&#xD;
             years&#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>Marshall Posner, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chaturvedi AK, Engels EA, Pfeiffer RM, Hernandez BY, Xiao W, Kim E, Jiang B, Goodman MT, Sibug-Saber M, Cozen W, Liu L, Lynch CF, Wentzensen N, Jordan RC, Altekruse S, Anderson WF, Rosenberg PS, Gillison ML. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. J Clin Oncol. 2011 Nov 10;29(32):4294-301. doi: 10.1200/JCO.2011.36.4596. Epub 2011 Oct 3.</citation>
    <PMID>21969503</PMID>
  </reference>
  <reference>
    <citation>Chaturvedi AK, Engels EA, Anderson WF, Gillison ML. Incidence trends for human papillomavirus-related and -unrelated oral squamous cell carcinomas in the United States. J Clin Oncol. 2008 Feb 1;26(4):612-9. doi: 10.1200/JCO.2007.14.1713.</citation>
    <PMID>18235120</PMID>
  </reference>
  <reference>
    <citation>Nasman A, Attner P, Hammarstedt L, Du J, Eriksson M, Giraud G, Ahrlund-Richter S, Marklund L, Romanitan M, Lindquist D, Ramqvist T, Lindholm J, Sparen P, Ye W, Dahlstrand H, Munck-Wikland E, Dalianis T. Incidence of human papillomavirus (HPV) positive tonsillar carcinoma in Stockholm, Sweden: an epidemic of viral-induced carcinoma? Int J Cancer. 2009 Jul 15;125(2):362-6. doi: 10.1002/ijc.24339.</citation>
    <PMID>19330833</PMID>
  </reference>
  <reference>
    <citation>Andl T, Kahn T, Pfuhl A, Nicola T, Erber R, Conradt C, Klein W, Helbig M, Dietz A, Weidauer H, Bosch FX. Etiological involvement of oncogenic human papillomavirus in tonsillar squamous cell carcinomas lacking retinoblastoma cell cycle control. Cancer Res. 1998 Jan 1;58(1):5-13.</citation>
    <PMID>9426048</PMID>
  </reference>
  <reference>
    <citation>Munger K, Baldwin A, Edwards KM, Hayakawa H, Nguyen CL, Owens M, Grace M, Huh K. Mechanisms of human papillomavirus-induced oncogenesis. J Virol. 2004 Nov;78(21):11451-60. doi: 10.1128/JVI.78.21.11451-11460.2004. No abstract available.</citation>
    <PMID>15479788</PMID>
  </reference>
  <reference>
    <citation>Psyrri A, DeFilippis RA, Edwards AP, Yates KE, Manuelidis L, DiMaio D. Role of the retinoblastoma pathway in senescence triggered by repression of the human papillomavirus E7 protein in cervical carcinoma cells. Cancer Res. 2004 May 1;64(9):3079-86. doi: 10.1158/0008-5472.can-03-3739.</citation>
    <PMID>15126344</PMID>
  </reference>
  <reference>
    <citation>Weinberger PM, Yu Z, Haffty BG, Kowalski D, Harigopal M, Brandsma J, Sasaki C, Joe J, Camp RL, Rimm DL, Psyrri A. Molecular classification identifies a subset of human papillomavirus--associated oropharyngeal cancers with favorable prognosis. J Clin Oncol. 2006 Feb 10;24(5):736-47. doi: 10.1200/JCO.2004.00.3335. Epub 2006 Jan 9.</citation>
    <PMID>16401683</PMID>
  </reference>
  <reference>
    <citation>Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.</citation>
    <PMID>20530316</PMID>
  </reference>
  <reference>
    <citation>Gillison ML, Koch WM, Capone RB, Spafford M, Westra WH, Wu L, Zahurak ML, Daniel RW, Viglione M, Symer DE, Shah KV, Sidransky D. Evidence for a causal association between human papillomavirus and a subset of head and neck cancers. J Natl Cancer Inst. 2000 May 3;92(9):709-20. doi: 10.1093/jnci/92.9.709.</citation>
    <PMID>10793107</PMID>
  </reference>
  <reference>
    <citation>Gillison ML. Human papillomavirus and prognosis of oropharyngeal squamous cell carcinoma: implications for clinical research in head and neck cancers. J Clin Oncol. 2006 Dec 20;24(36):5623-5. doi: 10.1200/JCO.2006.07.1829. No abstract available.</citation>
    <PMID>17179099</PMID>
  </reference>
  <reference>
    <citation>Ringstrom E, Peters E, Hasegawa M, Posner M, Liu M, Kelsey KT. Human papillomavirus type 16 and squamous cell carcinoma of the head and neck. Clin Cancer Res. 2002 Oct;8(10):3187-92.</citation>
    <PMID>12374687</PMID>
  </reference>
  <reference>
    <citation>Lassen P, Eriksen JG, Hamilton-Dutoit S, Tramm T, Alsner J, Overgaard J. Effect of HPV-associated p16INK4A expression on response to radiotherapy and survival in squamous cell carcinoma of the head and neck. J Clin Oncol. 2009 Apr 20;27(12):1992-8. doi: 10.1200/JCO.2008.20.2853. Epub 2009 Mar 16.</citation>
    <PMID>19289615</PMID>
  </reference>
  <reference>
    <citation>Licitra L, Perrone F, Bossi P, Suardi S, Mariani L, Artusi R, Oggionni M, Rossini C, Cantu G, Squadrelli M, Quattrone P, Locati LD, Bergamini C, Olmi P, Pierotti MA, Pilotti S. High-risk human papillomavirus affects prognosis in patients with surgically treated oropharyngeal squamous cell carcinoma. J Clin Oncol. 2006 Dec 20;24(36):5630-6. doi: 10.1200/JCO.2005.04.6136.</citation>
    <PMID>17179101</PMID>
  </reference>
  <reference>
    <citation>Cmelak AJ, Li S, Goldwasser MA, Murphy B, Cannon M, Pinto H, Rosenthal DI, Gillison M, Forastiere AA. Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx: results of Eastern Cooperative Oncology Group Study E2399. J Clin Oncol. 2007 Sep 1;25(25):3971-7. doi: 10.1200/JCO.2007.10.8951.</citation>
    <PMID>17761982</PMID>
  </reference>
  <reference>
    <citation>Fakhry C, Westra WH, Li S, Cmelak A, Ridge JA, Pinto H, Forastiere A, Gillison ML. Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst. 2008 Feb 20;100(4):261-9. doi: 10.1093/jnci/djn011. Epub 2008 Feb 12.</citation>
    <PMID>18270337</PMID>
  </reference>
  <reference>
    <citation>Worden FP, Kumar B, Lee JS, Wolf GT, Cordell KG, Taylor JM, Urba SG, Eisbruch A, Teknos TN, Chepeha DB, Prince ME, Tsien CI, D'Silva NJ, Yang K, Kurnit DM, Mason HL, Miller TH, Wallace NE, Bradford CR, Carey TE. Chemoselection as a strategy for organ preservation in advanced oropharynx cancer: response and survival positively associated with HPV16 copy number. J Clin Oncol. 2008 Jul 1;26(19):3138-46. doi: 10.1200/JCO.2007.12.7597. Epub 2008 May 12.</citation>
    <PMID>18474879</PMID>
  </reference>
  <reference>
    <citation>Rischin D, Young RJ, Fisher R, Fox SB, Le QT, Peters LJ, Solomon B, Choi J, O'Sullivan B, Kenny LM, McArthur GA. Prognostic significance of p16INK4A and human papillomavirus in patients with oropharyngeal cancer treated on TROG 02.02 phase III trial. J Clin Oncol. 2010 Sep 20;28(27):4142-8. doi: 10.1200/JCO.2010.29.2904. Epub 2010 Aug 9.</citation>
    <PMID>20697079</PMID>
  </reference>
  <reference>
    <citation>Lorch JH, Goloubeva O, Haddad RI, Cullen K, Sarlis N, Tishler R, Tan M, Fasciano J, Sammartino DE, Posner MR; TAX 324 Study Group. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial. Lancet Oncol. 2011 Feb;12(2):153-9. doi: 10.1016/S1470-2045(10)70279-5. Epub 2011 Jan 11.</citation>
    <PMID>21233014</PMID>
  </reference>
  <reference>
    <citation>Posner MR, Lorch JH, Goloubeva O, Tan M, Schumaker LM, Sarlis NJ, Haddad RI, Cullen KJ. Survival and human papillomavirus in oropharynx cancer in TAX 324: a subset analysis from an international phase III trial. Ann Oncol. 2011 May;22(5):1071-1077. doi: 10.1093/annonc/mdr006. Epub 2011 Feb 11.</citation>
    <PMID>21317223</PMID>
  </reference>
  <reference>
    <citation>Machtay M, Moughan J, Trotti A, Garden AS, Weber RS, Cooper JS, Forastiere A, Ang KK. Factors associated with severe late toxicity after concurrent chemoradiation for locally advanced head and neck cancer: an RTOG analysis. J Clin Oncol. 2008 Jul 20;26(21):3582-9. doi: 10.1200/JCO.2007.14.8841. Epub 2008 Jun 16.</citation>
    <PMID>18559875</PMID>
  </reference>
  <reference>
    <citation>Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008.</citation>
    <PMID>12506176</PMID>
  </reference>
  <reference>
    <citation>Forastiere A, Maor M, Weber R, Pajak, T, Glisson B, Trotti A, Ridge J, et al. Long term results of Intergroup RTOG 91-11: A Phase III trial to preserve the larynx - Induction cisplatin/5-FU and radiation therapy versus concurrent cisplatin and radiation therapy versus radiation therapy. Proceedings of the American Society of Clinical Oncology. 2006:5517.</citation>
  </reference>
  <reference>
    <citation>Staar S, Rudat V, Stuetzer H, Dietz A, Volling P, Schroeder M, Flentje M, Eckel HE, Mueller RP. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy--results of a multicentric randomized German trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1161-71. doi: 10.1016/s0360-3016(01)01544-9. Erratum In: Int J Radiat Oncol Biol Phys 2001 Oct 1;51(2):569.</citation>
    <PMID>11483325</PMID>
  </reference>
  <reference>
    <citation>Taylor SG 4th, Murthy AK, Vannetzel JM, Colin P, Dray M, Caldarelli DD, Shott S, Vokes E, Showel JL, Hutchinson JC, et al. Randomized comparison of neoadjuvant cisplatin and fluorouracil infusion followed by radiation versus concomitant treatment in advanced head and neck cancer. J Clin Oncol. 1994 Feb;12(2):385-95. doi: 10.1200/JCO.1994.12.2.385.</citation>
    <PMID>8113846</PMID>
  </reference>
  <reference>
    <citation>Best SR, Ha PK, Blanco RG, Saunders JR Jr, Zinreich ES, Levine MA, Pai SI, Walker M, Trachta J, Ulmer K, Murakami P, Thompson R, Califano JA, Messing BP. Factors associated with pharyngoesophageal stricture in patients treated with concurrent chemotherapy and radiation therapy for oropharyngeal squamous cell carcinoma. Head Neck. 2011 Dec;33(12):1727-34. doi: 10.1002/hed.21657. Epub 2011 Jan 18.</citation>
    <PMID>21246640</PMID>
  </reference>
  <reference>
    <citation>Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. doi: 10.1016/S1470-2045(09)70311-0. Epub 2009 Nov 10. Erratum In: Lancet Oncol. 2010 Jan;11(1):14.</citation>
    <PMID>19897418</PMID>
  </reference>
  <reference>
    <citation>Agoston ES, Robinson SJ, Mehra KK, Birch C, Semmel D, Mirkovic J, Haddad RI, Posner MR, Kindelberger D, Krane JF, Brodsky J, Crum CP. Polymerase chain reaction detection of HPV in squamous carcinoma of the oropharynx. Am J Clin Pathol. 2010 Jul;134(1):36-41. doi: 10.1309/AJCP1AAWXE5JJCLZ.</citation>
    <PMID>20551264</PMID>
  </reference>
  <reference>
    <citation>Harris SL, Thorne LB, Seaman WT, Hayes DN, Couch ME, Kimple RJ. Association of p16(INK4a) overexpression with improved outcomes in young patients with squamous cell cancers of the oral tongue. Head Neck. 2011 Nov;33(11):1622-7. doi: 10.1002/hed.21650. Epub 2010 Dec 28.</citation>
    <PMID>21990227</PMID>
  </reference>
  <reference>
    <citation>Schache AG, Liloglou T, Risk JM, Filia A, Jones TM, Sheard J, Woolgar JA, Helliwell TR, Triantafyllou A, Robinson M, Sloan P, Harvey-Woodworth C, Sisson D, Shaw RJ. Evaluation of human papilloma virus diagnostic testing in oropharyngeal squamous cell carcinoma: sensitivity, specificity, and prognostic discrimination. Clin Cancer Res. 2011 Oct 1;17(19):6262-71. doi: 10.1158/1078-0432.CCR-11-0388.</citation>
    <PMID>21969383</PMID>
  </reference>
  <reference>
    <citation>Maxwell JH, Kumar B, Feng FY, Worden FP, Lee JS, Eisbruch A, Wolf GT, Prince ME, Moyer JS, Teknos TN, Chepeha DB, McHugh JB, Urba SG, Stoerker J, Walline HM, Kurnit DM, Cordell KG, Davis SJ, Ward PD, Bradford CR, Carey TE. Tobacco use in human papillomavirus-positive advanced oropharynx cancer patients related to increased risk of distant metastases and tumor recurrence. Clin Cancer Res. 2010 Feb 15;16(4):1226-35. doi: 10.1158/1078-0432.CCR-09-2350. Epub 2010 Feb 9.</citation>
    <PMID>20145161</PMID>
  </reference>
  <reference>
    <citation>Anderson KS, Wong J, D'Souza G, Riemer AB, Lorch J, Haddad R, Pai SI, Longtine J, McClean M, LaBaer J, Kelsey KT, Posner M. Serum antibodies to the HPV16 proteome as biomarkers for head and neck cancer. Br J Cancer. 2011 Jun 7;104(12):1896-905. doi: 10.1038/bjc.2011.171.</citation>
    <PMID>21654689</PMID>
  </reference>
  <reference>
    <citation>Kumar B, Cordell KG, Lee JS, Worden FP, Prince ME, Tran HH, Wolf GT, Urba SG, Chepeha DB, Teknos TN, Eisbruch A, Tsien CI, Taylor JM, D'Silva NJ, Yang K, Kurnit DM, Bauer JA, Bradford CR, Carey TE. EGFR, p16, HPV Titer, Bcl-xL and p53, sex, and smoking as indicators of response to therapy and survival in oropharyngeal cancer. J Clin Oncol. 2008 Jul 1;26(19):3128-37. doi: 10.1200/JCO.2007.12.7662. Epub 2008 May 12.</citation>
    <PMID>18474878</PMID>
  </reference>
  <reference>
    <citation>Porceddu SV, Pryor DI, Burmeister E, Burmeister BH, Poulsen MG, Foote MC, Panizza B, Coman S, McFarlane D, Coman W. Results of a prospective study of positron emission tomography-directed management of residual nodal abnormalities in node-positive head and neck cancer after definitive radiotherapy with or without systemic therapy. Head Neck. 2011 Dec;33(12):1675-82. doi: 10.1002/hed.21655. Epub 2011 Jan 14.</citation>
    <PMID>22076976</PMID>
  </reference>
  <reference>
    <citation>Riemer AB, Keskin DB, Zhang G, Handley M, Anderson KS, Brusic V, Reinhold B, Reinherz EL. A conserved E7-derived cytotoxic T lymphocyte epitope expressed on human papillomavirus 16-transformed HLA-A2+ epithelial cancers. J Biol Chem. 2010 Sep 17;285(38):29608-22. doi: 10.1074/jbc.M110.126722. Epub 2010 Jul 8.</citation>
    <PMID>20615877</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>May 25, 2022</results_first_submitted>
  <results_first_submitted_qc>August 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2022</results_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Marshall Posner, MD</investigator_full_name>
    <investigator_title>Director, Head and Neck Medical Oncology</investigator_title>
  </responsible_party>
  <keyword>Reduced radiotherapy</keyword>
  <keyword>Randomization, Phase III</keyword>
  <keyword>Reduced radiation therapy</keyword>
  <keyword>head and neck</keyword>
  <keyword>oropharynx</keyword>
  <keyword>unknown primary (cervical lymph nodes)</keyword>
  <keyword>nasopharynx primary</keyword>
  <keyword>HPV</keyword>
  <keyword>p16</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>randomized trial should not be shared until trial is over.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT01706939/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>23 participants were assessed and started in pre-randomization induction phase. Participants were not randomized until after they completed the pre-randomization phase and TPF induction.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pre-Randomization</title>
          <description>Participants received three cycles of Docetaxel, Cisplatin and 5-RU (TPF)</description>
        </group>
        <group group_id="P2">
          <title>Reduced Dose Radiation</title>
          <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
        </group>
        <group group_id="P3">
          <title>Standard Dose Radiation</title>
          <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pre Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screen Failure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ineligible for Randomization</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </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 group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Insufficient QoL survey compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progression of disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Reduced Dose Radiation</title>
          <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
        </group>
        <group group_id="B2">
          <title>Standard Dose Radiation</title>
          <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</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="12"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55" lower_limit="36" upper_limit="78"/>
                    <measurement group_id="B2" value="57" lower_limit="36" upper_limit="78"/>
                    <measurement group_id="B3" value="56.5" lower_limit="36" upper_limit="78"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="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="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor Site</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Base of Tongue (BOT)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tonsil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HPV Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>HPV 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other than HPV 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Never smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;10 pack-years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-20 pack-years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Progression Free Survival (PFS)</title>
        <description>Progression free survival (PFS) at 5 years in patients with advanced HPV related oropharynx cancer, nasopharynx cancer or unknown primary treated with reduced or standard dose radiation.</description>
        <time_frame>at 3 and 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reduced Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
          <group group_id="O2">
            <title>Standard Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Progression Free Survival (PFS)</title>
          <description>Progression free survival (PFS) at 5 years in patients with advanced HPV related oropharynx cancer, nasopharynx cancer or unknown primary treated with reduced or standard dose radiation.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>at 3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at 5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Local-regional Control</title>
        <description>Local-regional control (LRC) at 3 years in patients with advanced HPV related oropharynx cancer or unknown primary treated with reduced or standard dose radiation.</description>
        <time_frame>at 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reduced Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
          <group group_id="O2">
            <title>Standard Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Local-regional Control</title>
          <description>Local-regional control (LRC) at 3 years in patients with advanced HPV related oropharynx cancer or unknown primary treated with reduced or standard dose radiation.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Overall Survival at 5 Years</title>
        <description>Overall Survival (OS) 5 years treated with reduced or standard dose CRT.</description>
        <time_frame>at 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reduced Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
          <group group_id="O2">
            <title>Standard Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Overall Survival at 5 Years</title>
          <description>Overall Survival (OS) 5 years treated with reduced or standard dose CRT.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT)</title>
        <description>Number of participants with acute toxicity treated with reduced or standard dose CRT.</description>
        <time_frame>at 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reduced Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
          <group group_id="O2">
            <title>Standard Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT)</title>
          <description>Number of participants with acute toxicity treated with reduced or standard dose CRT.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Biomarkers Predictive of Failure</title>
        <description>To determine biomarkers predictive of failure with either reduced or standard dose radiotherapy.</description>
        <time_frame>at 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reduced Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
          <group group_id="O2">
            <title>Standard Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Biomarkers Predictive of Failure</title>
          <description>To determine biomarkers predictive of failure with either reduced or standard dose radiotherapy.</description>
          <units>biomarkers</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="8"/>
              </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>
        <type>Secondary</type>
        <title>Overall Survival at 15 Years</title>
        <time_frame>at 15 years</time_frame>
        <posting_date>05/2035</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in MD Anderson Dysphagia Inventory (MDADI) From Baseline</title>
        <description>MDADI is a questionnaire of 20 questions and contains a global subscale, and three other categories of questions (emotional, functional, and physical). The scores are summed and a mean score is calculated. This mean score was multiplied by 20 to obtain a score, with a range of 0 (extremely low functioning) to 100 (high functioning). Thus, a higher MDADI score represented better day-to-day functioning and better QOL.</description>
        <time_frame>Baseline and 5 years</time_frame>
        <population>Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
          <group group_id="O2">
            <title>Standard Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in MD Anderson Dysphagia Inventory (MDADI) From Baseline</title>
          <description>MDADI is a questionnaire of 20 questions and contains a global subscale, and three other categories of questions (emotional, functional, and physical). The scores are summed and a mean score is calculated. This mean score was multiplied by 20 to obtain a score, with a range of 0 (extremely low functioning) to 100 (high functioning). Thus, a higher MDADI score represented better day-to-day functioning and better QOL.</description>
          <population>Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance.</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="9"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.12" spread="26.21"/>
                    <measurement group_id="O2" value="-8.93" spread="18.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS)</title>
        <description>MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS) MDASI Head and Neck is a site-specific MDASI module which includes the core MDASI 13 symptom severity items (SS) and 6 symptom interference items (SI), alongside 9 items relevant to head and neck cancer. The scores are summed and a mean score is calculated on a scale of 0 (low severity or interference) to 10 (high severity or complete interference). In order to calculate the mean score, a majority of the subscale's items must have been completed.&#xD;
A lower or negative score reflects a better quality of life compared to baseline.</description>
        <time_frame>Baseline and 5 years</time_frame>
        <population>Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
          <group group_id="O2">
            <title>Standard Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS)</title>
          <description>MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS) MDASI Head and Neck is a site-specific MDASI module which includes the core MDASI 13 symptom severity items (SS) and 6 symptom interference items (SI), alongside 9 items relevant to head and neck cancer. The scores are summed and a mean score is calculated on a scale of 0 (low severity or interference) to 10 (high severity or complete interference). In order to calculate the mean score, a majority of the subscale's items must have been completed.&#xD;
A lower or negative score reflects a better quality of life compared to baseline.</description>
          <population>Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance.</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="9"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MDASI-HN SI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="4.40"/>
                    <measurement group_id="O2" value="1.56" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MDASI-HN SS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" spread="2.11"/>
                    <measurement group_id="O2" value="1.48" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Xerostomia Questionnaire (XQ)</title>
        <description>XQ is a nine questions survey developed specifically for xerostomia symptoms. The scores are summed and a mean score is calculated on a scale of 0 (low xerostomia interference) to 10 (high xerostomia interference). A lower or negative score reflects a better quality of life compared to baseline.</description>
        <time_frame>Baseline and 5 years</time_frame>
        <population>Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
          <group group_id="O2">
            <title>Standard Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Xerostomia Questionnaire (XQ)</title>
          <description>XQ is a nine questions survey developed specifically for xerostomia symptoms. The scores are summed and a mean score is calculated on a scale of 0 (low xerostomia interference) to 10 (high xerostomia interference). A lower or negative score reflects a better quality of life compared to baseline.</description>
          <population>Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance.</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="9"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.18" spread="4.07"/>
                    <measurement group_id="O2" value="4.38" spread="2.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in European Organization for Research and Treatment of Cancer Questionnaire for Head and Neck (EORTC HN)</title>
        <description>The EORTC Head and Neck module was specifically designed and validated for head and neck cancer patients. This 35-item questionnaire contains 7 symptom scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality), 6 single-item scales (difficulties of teeth, mouth opening, dry mouth, sticky saliva, coughing, and feeling ill), and 5 items about the additional use of pain medicine, nutritional supplements, and feeding tube and changes in body weight. All items were transformed to scales from 0 to 100, and divided into respective sub-scores of global health (GHS), functional (FS), and symptom scale (SS). Subscales from 0-100. A high score on global health and functional scale represents a better level of functioning, whereas a high score on a symptom scale and head and neck module indicates more severe symptoms.</description>
        <time_frame>Baseline and 5 years</time_frame>
        <population>Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
          <group group_id="O2">
            <title>Standard Dose Radiation</title>
            <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in European Organization for Research and Treatment of Cancer Questionnaire for Head and Neck (EORTC HN)</title>
          <description>The EORTC Head and Neck module was specifically designed and validated for head and neck cancer patients. This 35-item questionnaire contains 7 symptom scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality), 6 single-item scales (difficulties of teeth, mouth opening, dry mouth, sticky saliva, coughing, and feeling ill), and 5 items about the additional use of pain medicine, nutritional supplements, and feeding tube and changes in body weight. All items were transformed to scales from 0 to 100, and divided into respective sub-scores of global health (GHS), functional (FS), and symptom scale (SS). Subscales from 0-100. A high score on global health and functional scale represents a better level of functioning, whereas a high score on a symptom scale and head and neck module indicates more severe symptoms.</description>
          <population>Of the 20 participants, 3 had progression of disease, and 2 were excluded due to insufficient survey compliance.</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="9"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EORTC GHS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.95" spread="27.52"/>
                    <measurement group_id="O2" value="-30.56" spread="31.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC FS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.14" spread="30.38"/>
                    <measurement group_id="O2" value="-6.33" spread="19.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC SS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.91" spread="22.36"/>
                    <measurement group_id="O2" value="14.97" spread="20.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC HN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.80" spread="20.55"/>
                    <measurement group_id="O2" value="8.97" spread="5.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 years</time_frame>
      <desc>Adverse Events were not collected for the pre-randomization phase. Adverse events assessed for participants who were randomized.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pre-Randomization</title>
          <description>Participants received three cycles of Docetaxel, Cisplatin and 5-RU (TPF)</description>
        </group>
        <group group_id="E2">
          <title>Reduced Dose Radiation</title>
          <description>After TPF induction chemotherapy patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin&#xD;
Reduced Dose Radiation: Reduced Dose Radiation (5600 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
        </group>
        <group group_id="E3">
          <title>Standard Dose Radiation</title>
          <description>After TPF induction chemotherapy patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin&#xD;
Standard Dose Radiation: Standard Dose Radiation (7000 cGy) dose radiotherapy&#xD;
Carboplatin: Day 1, every 7 days ( + 2 days)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (Unspecified)</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="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dental failure</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal scarring and fibrosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoradionecrosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Trigone oropharyngeal squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (Unspecified)</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="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Acute hearing loss</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Mucositis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Neutropenic fever</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Opiod overdose</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </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. Marshall R Posner</name_or_title>
      <organization>Icahn School of Medicine at Mount Sinai</organization>
      <phone>(212) 659-5461</phone>
      <email>marshall.posner@mssm.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/NCT01706939
org study id: GCO 12-1050
nct id: NCT01706939
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This trial aims to directly compare a reduced radiation dose to the standard of care in
      HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two
      groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are
      non-inferior to standard dose CRT.
This is a randomized Phase III study comparing two doses of definitive radiation therapy
      given with induction and concurrent chemotherapy in HPV-positive oropharynx, unknown primary
      or nasopharynx cancer. Eligible, consented and registered patients will receive three cycles
      of Docetaxel Cisplatin and 5-FU (TPF) induction chemotherapy. After 3 cycles, the patients
      will be assessed for clinical, radiographic and pathologic response to TPF. Patients with a
      clinical or radiographic CR or PR will be randomized on the second phase of this study, where
      patients will undergo a 2:1 randomization to reduced (5600 cGy) or standard (7000 cGy) dose
      radiotherapy with weekly Carboplatin. Patients not meeting the response criteria will be
      treated with standard dose CRT. Patients not completing 3 cycles TPF for reasons of toxicity,
      progressive disease, choice, or other medical necessity will be treated with standard dose
      CRT or surgery depending on their primary site and overall medical condition and followed for
      survival. Toxicity will be assessed by Symptom scores, QOL and SAE monitoring. The primary
      end point of the trial is equivalent local regional control and PFS at 3 years. Patients will
      be followed for 5 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Progression Free Survival (PFS)
time frame: at 3 and 5 years
description: Progression free survival (PFS) at 5 years in patients with advanced HPV related oropharynx cancer, nasopharynx cancer or unknown primary treated with reduced or standard dose radiation.
measure: Number of Participants With Local-regional Control
time frame: at 3 years
description: Local-regional control (LRC) at 3 years in patients with advanced HPV related oropharynx cancer or unknown primary treated with reduced or standard dose radiation.
measure: Number of Participants With Overall Survival at 5 Years
time frame: at 5 years
description: Overall Survival (OS) 5 years treated with reduced or standard dose CRT.
measure: Number of Participants With Acute Toxicity of Chemoradiotherapy (CRT)
time frame: at 5 years
description: Number of participants with acute toxicity treated with reduced or standard dose CRT.
measure: Biomarkers Predictive of Failure
time frame: at 5 years
description: To determine biomarkers predictive of failure with either reduced or standard dose radiotherapy.
measure: Overall Survival at 15 Years
time frame: at 15 years
measure: Change in MD Anderson Dysphagia Inventory (MDADI) From Baseline
time frame: Baseline and 5 years
description: MDADI is a questionnaire of 20 questions and contains a global subscale, and three other categories of questions (emotional, functional, and physical). The scores are summed and a mean score is calculated. This mean score was multiplied by 20 to obtain a score, with a range of 0 (extremely low functioning) to 100 (high functioning). Thus, a higher MDADI score represented better day-to-day functioning and better QOL.
measure: Change in MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS)
time frame: Baseline and 5 years
description: MD Anderson Symptom Inventory Symptom Inventory and Severity (MDASI-HN SI and SS) MDASI Head and Neck is a site-specific MDASI module which includes the core MDASI 13 symptom severity items (SS) and 6 symptom interference items (SI), alongside 9 items relevant to head and neck cancer. The scores are summed and a mean score is calculated on a scale of 0 (low severity or interference) to 10 (high severity or complete interference). In order to calculate the mean score, a majority of the subscale's items must have been completed.
A lower or negative score reflects a better quality of life compared to baseline.
measure: Change in Xerostomia Questionnaire (XQ)
time frame: Baseline and 5 years
description: XQ is a nine questions survey developed specifically for xerostomia symptoms. The scores are summed and a mean score is calculated on a scale of 0 (low xerostomia interference) to 10 (high xerostomia interference). A lower or negative score reflects a better quality of life compared to baseline.
measure: Change in European Organization for Research and Treatment of Cancer Questionnaire for Head and Neck (EORTC HN)
time frame: Baseline and 5 years
description: The EORTC Head and Neck module was specifically designed and validated for head and neck cancer patients. This 35-item questionnaire contains 7 symptom scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality), 6 single-item scales (difficulties of teeth, mouth opening, dry mouth, sticky saliva, coughing, and feeling ill), and 5 items about the additional use of pain medicine, nutritional supplements, and feeding tube and changes in body weight. All items were transformed to scales from 0 to 100, and divided into respective sub-scores of global health (GHS), functional (FS), and symptom scale (SS). Subscales from 0-100. A high score on global health and functional scale represents a better level of functioning, whereas a high score on a symptom scale and head and neck module indicates more severe symptoms.
arm group label: Reduced Dose Radiation
arm group type: Experimental
description: Patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin
arm group label: Standard Dose Radiation
arm group type: Active Comparator
description: Patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin
intervention type: Radiation
intervention name: Reduced Dose Radiation
description: Reduced Dose Radiation (5600 cGy) dose radiotherapy
arm group label: Reduced Dose Radiation
intervention type: Radiation
intervention name: Standard Dose Radiation
description: Standard Dose Radiation (7000 cGy) dose radiotherapy
arm group label: Standard Dose Radiation
intervention type: Drug
intervention name: Carboplatin
description: Day 1, every 7 days ( + 2 days)
arm group label: Reduced Dose Radiation
arm group label: Standard Dose Radiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marshall Posner, M.D.
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
citation: Chaturvedi AK, Engels EA, Pfeiffer RM, Hernandez BY, Xiao W, Kim E, Jiang B, Goodman MT, Sibug-Saber M, Cozen W, Liu L, Lynch CF, Wentzensen N, Jordan RC, Altekruse S, Anderson WF, Rosenberg PS, Gillison ML. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. J Clin Oncol. 2011 Nov 10;29(32):4294-301. doi: 10.1200/JCO.2011.36.4596. Epub 2011 Oct 3.
PMID: 21969503
citation: Chaturvedi AK, Engels EA, Anderson WF, Gillison ML. Incidence trends for human papillomavirus-related and -unrelated oral squamous cell carcinomas in the United States. J Clin Oncol. 2008 Feb 1;26(4):612-9. doi: 10.1200/JCO.2007.14.1713.
PMID: 18235120
citation: Nasman A, Attner P, Hammarstedt L, Du J, Eriksson M, Giraud G, Ahrlund-Richter S, Marklund L, Romanitan M, Lindquist D, Ramqvist T, Lindholm J, Sparen P, Ye W, Dahlstrand H, Munck-Wikland E, Dalianis T. Incidence of human papillomavirus (HPV) positive tonsillar carcinoma in Stockholm, Sweden: an epidemic of viral-induced carcinoma? Int J Cancer. 2009 Jul 15;125(2):362-6. doi: 10.1002/ijc.24339.
PMID: 19330833
citation: Andl T, Kahn T, Pfuhl A, Nicola T, Erber R, Conradt C, Klein W, Helbig M, Dietz A, Weidauer H, Bosch FX. Etiological involvement of oncogenic human papillomavirus in tonsillar squamous cell carcinomas lacking retinoblastoma cell cycle control. Cancer Res. 1998 Jan 1;58(1):5-13.
PMID: 9426048
citation: Munger K, Baldwin A, Edwards KM, Hayakawa H, Nguyen CL, Owens M, Grace M, Huh K. Mechanisms of human papillomavirus-induced oncogenesis. J Virol. 2004 Nov;78(21):11451-60. doi: 10.1128/JVI.78.21.11451-11460.2004. No abstract available.
PMID: 15479788
citation: Psyrri A, DeFilippis RA, Edwards AP, Yates KE, Manuelidis L, DiMaio D. Role of the retinoblastoma pathway in senescence triggered by repression of the human papillomavirus E7 protein in cervical carcinoma cells. Cancer Res. 2004 May 1;64(9):3079-86. doi: 10.1158/0008-5472.can-03-3739.
PMID: 15126344
citation: Weinberger PM, Yu Z, Haffty BG, Kowalski D, Harigopal M, Brandsma J, Sasaki C, Joe J, Camp RL, Rimm DL, Psyrri A. Molecular classification identifies a subset of human papillomavirus--associated oropharyngeal cancers with favorable prognosis. J Clin Oncol. 2006 Feb 10;24(5):736-47. doi: 10.1200/JCO.2004.00.3335. Epub 2006 Jan 9.
PMID: 16401683
citation: Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.
PMID: 20530316
citation: Gillison ML, Koch WM, Capone RB, Spafford M, Westra WH, Wu L, Zahurak ML, Daniel RW, Viglione M, Symer DE, Shah KV, Sidransky D. Evidence for a causal association between human papillomavirus and a subset of head and neck cancers. J Natl Cancer Inst. 2000 May 3;92(9):709-20. doi: 10.1093/jnci/92.9.709.
PMID: 10793107
citation: Gillison ML. Human papillomavirus and prognosis of oropharyngeal squamous cell carcinoma: implications for clinical research in head and neck cancers. J Clin Oncol. 2006 Dec 20;24(36):5623-5. doi: 10.1200/JCO.2006.07.1829. No abstract available.
PMID: 17179099
citation: Ringstrom E, Peters E, Hasegawa M, Posner M, Liu M, Kelsey KT. Human papillomavirus type 16 and squamous cell carcinoma of the head and neck. Clin Cancer Res. 2002 Oct;8(10):3187-92.
PMID: 12374687
citation: Lassen P, Eriksen JG, Hamilton-Dutoit S, Tramm T, Alsner J, Overgaard J. Effect of HPV-associated p16INK4A expression on response to radiotherapy and survival in squamous cell carcinoma of the head and neck. J Clin Oncol. 2009 Apr 20;27(12):1992-8. doi: 10.1200/JCO.2008.20.2853. Epub 2009 Mar 16.
PMID: 19289615
citation: Licitra L, Perrone F, Bossi P, Suardi S, Mariani L, Artusi R, Oggionni M, Rossini C, Cantu G, Squadrelli M, Quattrone P, Locati LD, Bergamini C, Olmi P, Pierotti MA, Pilotti S. High-risk human papillomavirus affects prognosis in patients with surgically treated oropharyngeal squamous cell carcinoma. J Clin Oncol. 2006 Dec 20;24(36):5630-6. doi: 10.1200/JCO.2005.04.6136.
PMID: 17179101
citation: Cmelak AJ, Li S, Goldwasser MA, Murphy B, Cannon M, Pinto H, Rosenthal DI, Gillison M, Forastiere AA. Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx: results of Eastern Cooperative Oncology Group Study E2399. J Clin Oncol. 2007 Sep 1;25(25):3971-7. doi: 10.1200/JCO.2007.10.8951.
PMID: 17761982
citation: Fakhry C, Westra WH, Li S, Cmelak A, Ridge JA, Pinto H, Forastiere A, Gillison ML. Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst. 2008 Feb 20;100(4):261-9. doi: 10.1093/jnci/djn011. Epub 2008 Feb 12.
PMID: 18270337
citation: Worden FP, Kumar B, Lee JS, Wolf GT, Cordell KG, Taylor JM, Urba SG, Eisbruch A, Teknos TN, Chepeha DB, Prince ME, Tsien CI, D'Silva NJ, Yang K, Kurnit DM, Mason HL, Miller TH, Wallace NE, Bradford CR, Carey TE. Chemoselection as a strategy for organ preservation in advanced oropharynx cancer: response and survival positively associated with HPV16 copy number. J Clin Oncol. 2008 Jul 1;26(19):3138-46. doi: 10.1200/JCO.2007.12.7597. Epub 2008 May 12.
PMID: 18474879
citation: Rischin D, Young RJ, Fisher R, Fox SB, Le QT, Peters LJ, Solomon B, Choi J, O'Sullivan B, Kenny LM, McArthur GA. Prognostic significance of p16INK4A and human papillomavirus in patients with oropharyngeal cancer treated on TROG 02.02 phase III trial. J Clin Oncol. 2010 Sep 20;28(27):4142-8. doi: 10.1200/JCO.2010.29.2904. Epub 2010 Aug 9.
PMID: 20697079
citation: Lorch JH, Goloubeva O, Haddad RI, Cullen K, Sarlis N, Tishler R, Tan M, Fasciano J, Sammartino DE, Posner MR; TAX 324 Study Group. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial. Lancet Oncol. 2011 Feb;12(2):153-9. doi: 10.1016/S1470-2045(10)70279-5. Epub 2011 Jan 11.
PMID: 21233014
citation: Posner MR, Lorch JH, Goloubeva O, Tan M, Schumaker LM, Sarlis NJ, Haddad RI, Cullen KJ. Survival and human papillomavirus in oropharynx cancer in TAX 324: a subset analysis from an international phase III trial. Ann Oncol. 2011 May;22(5):1071-1077. doi: 10.1093/annonc/mdr006. Epub 2011 Feb 11.
PMID: 21317223
citation: Machtay M, Moughan J, Trotti A, Garden AS, Weber RS, Cooper JS, Forastiere A, Ang KK. Factors associated with severe late toxicity after concurrent chemoradiation for locally advanced head and neck cancer: an RTOG analysis. J Clin Oncol. 2008 Jul 20;26(21):3582-9. doi: 10.1200/JCO.2007.14.8841. Epub 2008 Jun 16.
PMID: 18559875
citation: Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008.
PMID: 12506176
citation: Forastiere A, Maor M, Weber R, Pajak, T, Glisson B, Trotti A, Ridge J, et al. Long term results of Intergroup RTOG 91-11: A Phase III trial to preserve the larynx - Induction cisplatin/5-FU and radiation therapy versus concurrent cisplatin and radiation therapy versus radiation therapy. Proceedings of the American Society of Clinical Oncology. 2006:5517.
citation: Staar S, Rudat V, Stuetzer H, Dietz A, Volling P, Schroeder M, Flentje M, Eckel HE, Mueller RP. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy--results of a multicentric randomized German trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1161-71. doi: 10.1016/s0360-3016(01)01544-9. Erratum In: Int J Radiat Oncol Biol Phys 2001 Oct 1;51(2):569.
PMID: 11483325
citation: Taylor SG 4th, Murthy AK, Vannetzel JM, Colin P, Dray M, Caldarelli DD, Shott S, Vokes E, Showel JL, Hutchinson JC, et al. Randomized comparison of neoadjuvant cisplatin and fluorouracil infusion followed by radiation versus concomitant treatment in advanced head and neck cancer. J Clin Oncol. 1994 Feb;12(2):385-95. doi: 10.1200/JCO.1994.12.2.385.
PMID: 8113846
citation: Best SR, Ha PK, Blanco RG, Saunders JR Jr, Zinreich ES, Levine MA, Pai SI, Walker M, Trachta J, Ulmer K, Murakami P, Thompson R, Califano JA, Messing BP. Factors associated with pharyngoesophageal stricture in patients treated with concurrent chemotherapy and radiation therapy for oropharyngeal squamous cell carcinoma. Head Neck. 2011 Dec;33(12):1727-34. doi: 10.1002/hed.21657. Epub 2011 Jan 18.
PMID: 21246640
citation: Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. doi: 10.1016/S1470-2045(09)70311-0. Epub 2009 Nov 10. Erratum In: Lancet Oncol. 2010 Jan;11(1):14.
PMID: 19897418
citation: Agoston ES, Robinson SJ, Mehra KK, Birch C, Semmel D, Mirkovic J, Haddad RI, Posner MR, Kindelberger D, Krane JF, Brodsky J, Crum CP. Polymerase chain reaction detection of HPV in squamous carcinoma of the oropharynx. Am J Clin Pathol. 2010 Jul;134(1):36-41. doi: 10.1309/AJCP1AAWXE5JJCLZ.
PMID: 20551264
citation: Harris SL, Thorne LB, Seaman WT, Hayes DN, Couch ME, Kimple RJ. Association of p16(INK4a) overexpression with improved outcomes in young patients with squamous cell cancers of the oral tongue. Head Neck. 2011 Nov;33(11):1622-7. doi: 10.1002/hed.21650. Epub 2010 Dec 28.
PMID: 21990227
citation: Schache AG, Liloglou T, Risk JM, Filia A, Jones TM, Sheard J, Woolgar JA, Helliwell TR, Triantafyllou A, Robinson M, Sloan P, Harvey-Woodworth C, Sisson D, Shaw RJ. Evaluation of human papilloma virus diagnostic testing in oropharyngeal squamous cell carcinoma: sensitivity, specificity, and prognostic discrimination. Clin Cancer Res. 2011 Oct 1;17(19):6262-71. doi: 10.1158/1078-0432.CCR-11-0388.
PMID: 21969383
citation: Maxwell JH, Kumar B, Feng FY, Worden FP, Lee JS, Eisbruch A, Wolf GT, Prince ME, Moyer JS, Teknos TN, Chepeha DB, McHugh JB, Urba SG, Stoerker J, Walline HM, Kurnit DM, Cordell KG, Davis SJ, Ward PD, Bradford CR, Carey TE. Tobacco use in human papillomavirus-positive advanced oropharynx cancer patients related to increased risk of distant metastases and tumor recurrence. Clin Cancer Res. 2010 Feb 15;16(4):1226-35. doi: 10.1158/1078-0432.CCR-09-2350. Epub 2010 Feb 9.
PMID: 20145161
citation: Anderson KS, Wong J, D'Souza G, Riemer AB, Lorch J, Haddad R, Pai SI, Longtine J, McClean M, LaBaer J, Kelsey KT, Posner M. Serum antibodies to the HPV16 proteome as biomarkers for head and neck cancer. Br J Cancer. 2011 Jun 7;104(12):1896-905. doi: 10.1038/bjc.2011.171.
PMID: 21654689
citation: Kumar B, Cordell KG, Lee JS, Worden FP, Prince ME, Tran HH, Wolf GT, Urba SG, Chepeha DB, Teknos TN, Eisbruch A, Tsien CI, Taylor JM, D'Silva NJ, Yang K, Kurnit DM, Bauer JA, Bradford CR, Carey TE. EGFR, p16, HPV Titer, Bcl-xL and p53, sex, and smoking as indicators of response to therapy and survival in oropharyngeal cancer. J Clin Oncol. 2008 Jul 1;26(19):3128-37. doi: 10.1200/JCO.2007.12.7662. Epub 2008 May 12.
PMID: 18474878
citation: Porceddu SV, Pryor DI, Burmeister E, Burmeister BH, Poulsen MG, Foote MC, Panizza B, Coman S, McFarlane D, Coman W. Results of a prospective study of positron emission tomography-directed management of residual nodal abnormalities in node-positive head and neck cancer after definitive radiotherapy with or without systemic therapy. Head Neck. 2011 Dec;33(12):1675-82. doi: 10.1002/hed.21655. Epub 2011 Jan 14.
PMID: 22076976
citation: Riemer AB, Keskin DB, Zhang G, Handley M, Anderson KS, Brusic V, Reinhold B, Reinherz EL. A conserved E7-derived cytotoxic T lymphocyte epitope expressed on human papillomavirus 16-transformed HLA-A2+ epithelial cancers. J Biol Chem. 2010 Sep 17;285(38):29608-22. doi: 10.1074/jbc.M110.126722. Epub 2010 Jul 8.
PMID: 20615877
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Marshall Posner, MD
investigator title: Director, Head and Neck Medical Oncology
mesh term: Oropharyngeal Neoplasms
mesh term: Carboplatin
sharing ipd: Undecided
ipd description: randomized trial should not be shared until trial is over.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 