Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

Tracking Information
First Submitted Date ICMJE	May 7, 2014
First Posted Date ICMJE	May 9, 2014
Last Update Posted Date	November 6, 2018
Study Start Date ICMJE	April 2014
Estimated Primary Completion Date	July 2021 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 29, 2016)	Overall survival (OS) (Undetectable Plasma EBV DNA Cohort Phase III) [ Time Frame: Up to 7 years ]Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test. The confidence interval approach will be used for the final analysis of OS.; Progression-free survival (PFS) (Detectable Plasma EBV DNA Cohort Phase II) [ Time Frame: Up to 7 years ]Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test. A one-sided log rank test will be used to compare the PFS at a significance level of 0.1379.
Original Primary Outcome Measures ICMJE; (submitted: May 8, 2014)	Progression-free survival (PFS) (Detectable Plasma EBV DNA Cohort Phase II) [ Time Frame: Up to 7 years ]Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test. A one-sided log rank test will be used to compare the PFS at a significance level of 0.1379.; Overall survival (OS) (Undetectable Plasma EBV DNA Cohort Phase III) [ Time Frame: Up to 7 years ]Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test. The confidence interval approach will be used for the final analysis of OS.
Change History	Complete list of historical versions of study NCT02135042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 29, 2016)	Changes in pure tone audiometry (Phase II and III) [ Time Frame: Baseline to up to 1 year ]Correlation between categorical measures will be summarized by odds ratios, chi-square tests, and associated measures. Adjusted correlation may be derived from analysis of covariance (ANCOVA) models or derived directly using nonparametric analysis of variance (ANOVA) models if normality assumption is violated. Correlations between HHIE-S PRO scores and PTA and FACT-NP hearing, and PTA will be compared as dependent statistics; Changes in QOL (hearing) as assessed by the Hearing Handicap Inventory for the Elderly-Screening version (HHIE-S) (Phase II and III) [ Time Frame: Baseline to up to 24 months ]QOL analysis including overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm. Overall and nasopharyngeal-specific QOL, hearing QOL (FACT-NP hearing domain, HHIE-S scores), peripheral neuropathy QOL over the short and long term and pure-tone audiometry (PTA) scores will be compared using a two sample independent t test and paired t test if the comparison is within the experimental arm between different time points.; Changes in QOL (peripheral neuropathy) as assessed by the FACT-Taxane (Phase II and III) [ Time Frame: Baseline to up to 24 months ]; Changes in quality of life (QOL) (general and physical well-being) assessed using the Functional Assessment of Cancer Therapy (FACT)-Nasopharyngeal (NP) (Phase II and III) [ Time Frame: Baseline to up to 24 months ]Changes in patient reported outcome (PRO) scores will be correlated to clearance or non-clearance of EBV titers. Descriptive statistics derived from FACT-NP will be used to enrich the understanding of QOL as it pertains to the 2 phase III arms of observation versus additional adjuvant chemotherapy. Univariable and multivariable analysis will be performed using the Cox proportional hazards model for OS and distant metastasis. Pearson correlation will be estimated between general and physical well-being. QOL measures and change from baseline will be correlated to EBV DNA.; Cost effectiveness as assessed by the health-related QOL (HRQOL) from the EuroQol (EQ-5D) instrument (Phase II and III) [ Time Frame: Up to 24 months ]Incremental cost effectiveness ratios will be compared to determine the probability of cost effectiveness of various interventions, with sensitivity analyses to identify model weaknesses. The expected value of perfect information will be determined to delimit the upper boundary for cost-effective future investment in this area of research.; Incidence of acute grade 3-5 adverse events (Phase II and III) [ Time Frame: Up to 7 years ]Rates of specific acute toxicity profiles and late toxicity profiles will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test between the 2 treatment arms.; Incidence of death (Phase II and III) [ Time Frame: Up to 30 days of end of protocol treatment ]; Incidence of late grade 3-5 adverse events (Phase II and III) [ Time Frame: Up to 7 years ]Rates of specific acute toxicity profiles and late toxicity profiles will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test between the 2 treatment arms.; OS (Detectable Plasma EBV DNA Cohort Phase II) [ Time Frame: Up to 7 years ]Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test.; PFS (Undetectable Plasma EBV DNA Cohort Phase III) [ Time Frame: Up to 7 years ]Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test.; Time to distant metastasis (DM) (Phase II and III) [ Time Frame: Up to 7 years ]The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model.; Time to local progression (Phase II and III) [ Time Frame: Up to 7 years ]The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model.; Time to regional progression (Phase II and III) [ Time Frame: Up to 7 years ]Defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model.
Original Secondary Outcome Measures ICMJE; (submitted: May 8, 2014)	Time to distant metastasis (DM) (Phase II and III) [ Time Frame: Up to 7 years ]The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model.; Time to local progression (Phase II and III) [ Time Frame: Up to 7 years ]The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model.; Time to regional progression (Phase II and III) [ Time Frame: Up to 7 years ]Defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. The cumulative incidence method will be used to estimate local, regional, and distant failure rates. The failure rates for the experimental treatment will be compared against the control using a failure-specific log-rank test. Multivariate analysis will be performed using the Cox proportional hazards model.; PFS (Undetectable Plasma EBV DNA Cohort Phase III) [ Time Frame: Up to 7 years ]Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test.; OS (Detectable Plasma EBV DNA Cohort Phase II) [ Time Frame: Up to 7 years ]Estimated using the Kaplan-Meier method for each arm. Their distributions will be compared between treatment arms with a 1-sided log rank test.; Incidence of acute grade 3-5 adverse events (Phase II and III) [ Time Frame: Up to 7 years ]Rates of specific acute toxicity profiles and late toxicity profiles will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test between the 2 treatment arms.; Incidence of late grade 3-5 adverse events (Phase II and III) [ Time Frame: Up to 7 years ]Rates of specific acute toxicity profiles and late toxicity profiles will be estimated using a binomial distribution along with their associated 95% confidence intervals and will be compared using Fisher's exact test between the 2 treatment arms.; Incidence of death (Phase II and III) [ Time Frame: Up to 30 days of end of protocol treatment ]; Changes in pure tone audiometry (Phase II and III) [ Time Frame: Baseline to up to 1 year ]Correlation between categorical measures will be summarized by odds ratios, chi-square tests, and associated measures. Adjusted correlation may be derived from analysis of covariance (ANCOVA) models or derived directly using nonparametric analysis of variance (ANOVA) models if normality assumption is violated. Correlations between HHIE-S PRO scores and PTA and FACT-NP hearing, and PTA will be compared as dependent statistics; Changes in quality of life (QOL) (general and physical well-being) assessed using the Functional Assessment of Cancer Therapy (FACT)-Nasopharyngeal (NP) (Phase II and III) [ Time Frame: Baseline to up to 24 months ]Changes in patient reported outcome (PRO) scores will be correlated to clearance or non-clearance of EBV titers. Descriptive statistics derived from FACT-NP will be used to enrich the understanding of QOL as it pertains to the 2 phase III arms of observation versus additional adjuvant chemotherapy. Univariable and multivariable analysis will be performed using the Cox proportional hazards model for OS and distant metastasis. Pearson correlation will be estimated between general and physical well-being. QOL measures and change from baseline will be correlated to EBV DNA.; Changes in QOL (hearing) as assessed by the Hearing Handicap Inventory for the Elderly-Screening version (HHIE-S) (Phase II and III) [ Time Frame: Baseline to up to 24 months ]QOL analysis including overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm. Overall and nasopharyngeal-specific QOL, hearing QOL (FACT-NP hearing domain, HHIE-S scores), peripheral neuropathy QOL over the short and long term and pure-tone audiometry (PTA) scores will be compared using a two sample independent t test and paired t test if the comparison is within the experimental arm between different time points.; Changes in QOL (peripheral neuropathy) as assessed by the FACT-Taxane (Phase II and III) [ Time Frame: Baseline to up to 24 months ]; Cost effectiveness as assessed by the health-related QOL (HRQOL) from the EuroQol (EQ-5D) instrument (Phase II and III) [ Time Frame: Up to 24 months ]Incremental cost effectiveness ratios will be compared to determine the probability of cost effectiveness of various interventions, with sensitivity analyses to identify model weaknesses. The expected value of perfect information will be determined to delimit the upper boundary for cost-effective future investment in this area of research.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
Official Title ICMJE	Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
Brief Summary	There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Detailed Description	PRIMARY OBJECTIVES: I. To determine whether substituting adjuvant concurrent high dose cisplatin (CDDP) and fluorouracil (5-FU) with gemcitabine (gemcitabine hydrochloride) and paclitaxel will result in superior progression-free survival. (Detectable Plasma Epstein Barr Virus [EBV] Deoxyribonucleic Acid [DNA] Cohort randomized Phase II) II. To determine whether omitting adjuvant CDDP and 5-FU (observation alone in the adjuvant setting) will result in non-inferior overall survival as compared with those patients receiving adjuvant CDDP and 5-FU chemotherapy. (Undetectable Plasma EBV DNA Cohort Phase III) SECONDARY OBJECTIVES: I. Time to distant metastasis. (Randomized Phase II and Phase III) II. Time to local progression. (Randomized Phase II and Phase III) III. Time to regional progression. (Randomized Phase II and Phase III) IV. Progression-free survival (Undetectable Cohort). V. Overall survival (Detectable Cohort). VI. Acute and late toxicity profiles based on clinician-reported Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4. (Randomized Phase II and Phase III) VII. Death during or within 30 days of end of protocol treatment. (Randomized Phase II and Phase III) VIII. Quality of life (general and physical well-being). (Randomized Phase II and Phase III) IX. Quality of life (hearing). (Randomized Phase II and Phase III) X. Quality of life (peripheral neuropathy). (Randomized Phase II and Phase III) XI. Cost effectiveness. (Randomized Phase II and Phase III) OUTLINE: Patients undergo intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6.5 weeks and receive low-dose cisplatin intravenously (IV) over 30-60 minutes once weekly during IMRT. Beginning 1 week after chemoradiation, plasma samples are collected for EBV DNA analysis. PHASE II: Patients with detectable EBV DNA from pre-treatment analysis are randomized to 1 of 2 treatment arms. ARM I: Patients receive PF regimen comprising cisplatin IV over 60-120 minutes and fluorouracil IV over 96 hours continuously beginning at least 4 weeks after completion of IMRT. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive GT regimen comprising paclitaxel IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 at least 4 weeks after completion of IMRT. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. PHASE III: Patients with undetectable EBV DNA from pre-treatment analysis are randomized to 1 of 2 treatment arms. ARM III: Patients receive PF regimen as in Arm I. ARM IV: Patients undergo clinical observation. After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study Type ICMJE	Interventional
Study Phase	Phase 2; Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Epstein-Barr Virus Infection; Stage II Nasopharyngeal Carcinoma; Stage III Nasopharyngeal Carcinoma; Stage IVA Nasopharyngeal Carcinoma; Stage IVB Nasopharyngeal Carcinoma
Intervention ICMJE	Drug: Cisplatin Given IV Other Names: Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin; Other: Clinical Observation Undergo clinical observation; Drug: Fluorouracil Given IV Other Names: 5-Fluoro-2,4(1H, 3H)-pyrimidinedione 5-Fluorouracil 5-Fluracil 5-FU AccuSite Actino-Hermal Adrucil Arumel Cytosafe Efudex Efurix Fiverocil Fluoro Uracil Fluoroplex Fluouracil Flurablastin Fluracedyl Fluracil Fluril Fluroblastin Flurox Ribofluor Ro 2-9757 Ro-2-9757 Timazin; Drug: Gemcitabine Hydrochloride Given IV Other Names: dFdCyd Difluorodeoxycytidine Hydrochloride Gemzar LY-188011; Radiation: Intensity-Modulated Radiation Therapy Undergo IMRT Other Names: IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy; Other: Laboratory Biomarker Analysis Correlative studies; Drug: Paclitaxel Given IV Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat; Other: Quality-of-Life Assessment Ancillary studies Other Name: Quality of Life Assessment
Study Arms	Active Comparator: Arm I (chemoradiation, cisplatin, fluorouracil) Patients receive PF regimen comprising cisplatin IV over 60-120 minutes and fluorouracil IV over 96 hours continuously beginning at least 4 weeks after completion of IMRT. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Interventions: Drug: Cisplatin Drug: Fluorouracil Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment; Experimental: Arm II (chemoradiation, gemcitabine hydrochloride, paclitaxel) Patients receive GT regimen comprising paclitaxel IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 at least 4 weeks after completion of IMRT. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Interventions: Drug: Cisplatin Drug: Gemcitabine Hydrochloride Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Drug: Paclitaxel Other: Quality-of-Life Assessment; Active Comparator: Arm III (chemoradiation, cisplatin, fluorouracil) Patients receive PF regimen as in Arm I of Phase II. Interventions: Drug: Cisplatin Drug: Fluorouracil Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment; Experimental: Arm IV (chemoradiation, observation) Patients undergo clinical observation. Interventions: Drug: Cisplatin Other: Clinical Observation Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: May 8, 2014)	924
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	July 2026
Estimated Primary Completion Date	July 2021 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx; Patients must have detectable pretreatment plasma EBV DNA, determined by the central lab prior to Step 2 registration; Stage II-IVB disease (American Joint Committee on Cancer [AJCC], 7th edition [ed.]) with no evidence of distant metastasis, based upon the following minimum diagnostic workup: History/physical examination by a Medical Oncologist or Clinical Oncologist or Radiation Oncologist or Ear, Nose, Throat specialist (ENT), which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past 6 months within 21 days prior to registration Evaluation of tumor extent with magnetic resonance imaging (MRI) of the nasopharynx and neck within 28 days prior to registration; if MRI is medically contraindicated, obtain computed tomography (CT) scan with =< 3 mm contiguous slices with contrast and bone windows (to evaluate base of skull involvement); Note: If a treatment planning CT scan is used, it must be with =< 3 mm contiguous slices with contrast and be read by a radiologist To rule out distant metastasis, patients must undergo the following imaging within 28 days prior to registration: A CT scan with contrast of the chest, abdomen, and/or pelvis or a total body positron emission tomography (PET)/CT scan (non-contrast PET/CT is acceptable) A bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan); Zubrod performance status 0-1 within 21 days prior to registration; Absolute neutrophil count (ANC) >= 1,500 cells/mm^3; Platelets >= 100,000 cells/mm^3; Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable); Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 1.5 x institutional ULN; Alkaline phosphatase =< 1.5 x institutional ULN; Serum creatinine =< 1.5 mg/dl or calculated creatinine clearance (CC) >= 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula; Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential; Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment; Patient must provide study specific informed consent prior to study entry, including the mandatory pre-treatment plasma EBV DNA assay Exclusion Criteria: Prior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible); Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin; Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss from tumor-related otitis media is allowed; >= Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0); Severe, active co-morbidity, defined as follows: Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy Unstable angina and/or uncontrolled congestive heart failure Myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; Prior allergic reaction to the study drug(s) involved in this protocol; Patients with undetectable pre-treatment plasma EBV DNA
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE
Listed Location Countries ICMJE	Australia, Canada, China, Hong Kong, Singapore, Taiwan, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT02135042
Other Study ID Numbers ICMJE	NRG-HN001; NCI-2014-00635 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); RTOG-1305; NRG-HN001 ( Other Identifier: NRG Oncology ); NRG-HN001 ( Other Identifier: CTEP ); U10CA180868 ( U.S. NIH Grant/Contract ); U10CA021661 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	NRG Oncology
Study Sponsor ICMJE	NRG Oncology
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: Nancy Lee NRG Oncology
PRS Account	NRG Oncology
Verification Date	November 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP