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Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cisplatin
Standard fractionation RT
Accelerated fractionation radiation therapy
Conventional surgery for select patients
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0) No metastases below the clavicle or more distant by clinical exam or radiology PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 mg/dL Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal Renal Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Calcium normal Cardiovascular No symptomatic coronary artery disease (angina) No myocardial infarction within the past 6 months Other No other invasive malignancy within the past 3 years except nonmelanoma skin cancer No simultaneous primary tumors Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the head and neck except radioactive iodine therapy Surgery No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease No radical or modified neck dissection

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • Mobile Infirmary Medical Center
  • Foundation for Cancer Research and Education
  • CCOP - Mayo Clinic Scottsdale Oncology Program
  • Scottsdale Healthcare - Shea
  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
  • Providence Saint Joseph Medical Center - Burbank
  • Saint Rose Hospital
  • Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
  • Valley Memorial Hospital
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Providence Holy Cross Cancer Center
  • Highland General Hospital
  • CCOP - Bay Area Tumor Institute
  • Summit Medical Center
  • Pomona Valley Hospital Medical Center
  • Radiological Associates of Sacramento Medical Group, Inc.
  • University of California Davis Cancer Center
  • Naval Medical Center - San Diego
  • J.C. Robinson, M.D. Regional Cancer Center
  • Memorial Hospital Cancer Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Beebe Medical Center
  • CCOP - Christiana Care Health Services
  • St. Francis Hospital
  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  • 21st Century Oncology - Fort Myers
  • Shands Cancer Center at the University of Florida - Jacksonville
  • Memorial Cancer Institute at Memorial Regional Hospital
  • Baptist Cancer Institute - Jacksonville
  • University of Florida Shands Cancer Center
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  • CCOP - Mount Sinai Medical Center
  • Gulf Coast Cancer Treatment Center
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • Georgia Cancer Center for Excellence at Grady Memorial Hospital
  • Emory University Hospital - Atlanta
  • John B. Amos Community Cancer Center
  • Northeast Georgia Medical Center
  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  • Northwest Community Hospital
  • Mount Sinai Hospital Medical Center
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Creticos Cancer Center at Advocate Illinois Masonic Medical Center
  • Cancer Care Center at Advocate Good Samaritan Hospital
  • Alexian Brothers Cancer Care Center
  • Ingalls Cancer Care Center at Ingalls Memorial Hospital
  • St. John's Cancer Center at St. John's Medical Center
  • St. Francis Hospital and Health Centers
  • Elkhart General Hospital
  • Indiana University Cancer Center
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • Saint Joseph Regional Medical Center - Plymouth Campus
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Wendt Regional Cancer Center at Finley Hospital
  • Cancer Treatment Center at the Medical Center - Bowling Green
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • James Graham Brown Cancer Center at University of Louisville
  • Baton Rouge General Regional Cancer Center
  • Mary Bird Perkins Cancer Center - Baton Rouge
  • Cancer Center at Medical Center of Louisiana - New Orleans
  • MBCCOP - LSU Health Sciences Center
  • Tulane Cancer Center
  • New Orleans Cancer Institute at Memorial Medical Center
  • DeCesaris Cancer Institute at Anne Arundel Medical Center
  • Union Hospital Cancer Center at Union Hospital
  • Massachusetts General Hospital Cancer Center
  • Cancer Research Center at Boston Medical Center
  • Hudner Oncology Center at Saint Anne's Hospital
  • Cape Cod Hospital
  • South Suburban Oncology Center
  • CCOP - Michigan Cancer Research Consortium
  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Barbara Ann Karmanos Cancer Institute
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Hurley Medical Center
  • Genesys Hurley Cancer Institute
  • Great Lakes Cancer Institute at McLaren Regional Medical Center
  • Borgess Medical Center
  • CCOP - Kalamazoo
  • Bronson Methodist Hospital
  • West Michigan Cancer Center
  • Seton Cancer Institute - Saginaw
  • St. John Macomb Hospital
  • Mayo Clinic Cancer Center
  • Cancer Institute of Cape Girardeau
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • CCOP - Kansas City
  • Saint Louis University Cancer Center
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • CCOP - Cancer Research for the Ozarks
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
  • University Medical Center of Southern Nevada
  • CCOP - Southern Nevada Cancer Research Foundation
  • Washoe Cancer Services at Washoe Medical Center - Reno
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Cancer Institute of New Jersey at the Cooper University Hospital
  • Monmouth Medical Center
  • South Jersey Healthcare Regional Cancer Center
  • Fox Chase Virtua Health Cancer Program - Marlton
  • Community Medical Center
  • New York Methodist Hospital
  • Roswell Park Cancer Institute
  • CCOP - North Shore University Hospital
  • Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
  • SUNY Upstate Medical University Hospital
  • Randolph Hospital
  • John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
  • Wayne Memorial Hospital, Incorporated
  • Wayne Radiation Oncology
  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital
  • Annie Penn Cancer Center
  • Rutherford Hospital
  • Wilson Medical Center
  • Comprehensive Cancer Center at Wake Forest University
  • Trinity Cancer Care Center
  • Akron City Hospital at Summa Health System
  • McDowell Cancer Center at Akron General Medical Center
  • Aultman Hospital Cancer Center at Aultman Health Foundation
  • Grandview Hospital
  • Good Samaritan Hospital
  • Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • Charles F. Kettering Memorial Hospital
  • St. Rita's Medical Center
  • Middletown Regional Hospital
  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Cancer Treatment Center
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • LaFortune Cancer Center at St. John Health System
  • Natalie Warren Bryant Cancer Center at St. Francis Hospital
  • Abington Memorial Hospital
  • Bryn Mawr Hospital
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Cancer Center at Paoli Memorial Hospital
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center
  • Albert Einstein Cancer Center
  • Mercy Hospital of Pittsburgh
  • Mercy Hospital Cancer Center - Scranton
  • CCOP - MainLine Health
  • Lankenau Cancer Center at Lankenau Hospital
  • Rose Ramer Cancer Clinic at Anderson Area Medical Center
  • Bon Secours St. Francis Health System
  • Greenville Hospital System Cancer Center
  • CCOP - Greenville
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • CCOP - Upstate Carolina
  • Rapid City Regional Hospital
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • Harrington Cancer Center
  • Brooke Army Medical Center
  • M.D. Anderson Cancer Center at University of Texas
  • Wilford Hall Medical Center
  • Cottonwood Hospital Medical Center
  • McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center
  • Utah Cancer Specialists at UCS Cancer Center
  • Huntsman Cancer Institute at University of Utah
  • LDS Hospital
  • Fletcher Allen Health Care - University Health Center Campus
  • Danville Regional Medical Center
  • Rappahannock General Hospital
  • Naval Medical Center - Portsmouth
  • Veterans Affairs Medical Center - Richmond
  • Massey Cancer Center at Virginia Commonwealth University
  • Community Memorial Health Center
  • North Star Lodge Cancer Center
  • Washington Hematology - Oncology Specialists
  • Schiffler Cancer Center at Wheeling Hospital
  • Green Bay Oncology, Limited at St. Vincent Hospital
  • St. Vincent Hospital
  • Green Bay Oncology, Limited at St. Mary's Hospital
  • St. Mary's Hospital Medical Center
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  • University of Wisconsin Comprehensive Cancer Center
  • Holy Family Memorial Medical Center
  • Bay Area Cancer Care Center at Bay Area Medical Center
  • Community Memorial Hospital
  • St. Mary's Cancer Center at Columbia St. Mary's Hospital - Milwaukee Campus
  • Medical College of Wisconsin Cancer Center
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)
  • Oconomowoc Memorial Hospital
  • All Saints Cancer Center at All Saints Healthcare
  • Waukesha Memorial Hospital Regional Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard fractionation RT + cisplatin

Accelerated fractionation RT + cisplatin

Arm Description

Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.

Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.

Outcomes

Primary Outcome Measures

Overall Survival (Percentage of Participants Alive)
Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.

Secondary Outcome Measures

Local-regional Failure (Percentage of Participants With Local-regional Failure)
Local-regional failure time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), death (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]
Local-regional failure time is defined as time from randomization to relapse/progression in the primary tumor or regional nodes (event), death due to study cancer or unknown causes (event), death due to other causes (competing event), distant metastasis (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Disease-free Survival (Percentage of Participants Alive Without Disease)
Disease-free survival time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), distant metastasis (event), second primary tumor (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]
Progression-free survival time is defined as time from randomization to relapse/progression in the primary site or regional nodes (event), distant metastasis (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Percentage of Participants With Toxicity Grade 3 or Higher
Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data.
Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year
The PSS-HN is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet (this outcome measure), Public Eating, and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and one year calculated by use of area under the curve (AUC).
PSS-HN Public Eating Score - AUC at One Year
The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating (this outcome measure), and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC).
PSS-HN Understandability of Speech Score - AUC at One Year
The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating, and Understandability of Speech (this outcome measure). Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC).
Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year
The HNRQ is a patient-reported questionnaire administrated through a paper format; it measures radiation-related side effects and the overall well-being of head and neck cancer patients in the past week. The overall score is the mean of the 22 questions, with a range of 1 to 7. Higher scores indicate better quality of life. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and 1 year calculated by use of area under the curve (AUC).
Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes
Correlation of COX-2 With Outcomes

Full Information

First Posted
October 3, 2002
Last Updated
July 3, 2023
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00047008
Brief Title
Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer
Official Title
A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 2002 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.
Detailed Description
OBJECTIVES: Primary Compare overall survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with conventional vs accelerated radiotherapy and concurrent cisplatin with or without surgical resection. Secondary Compare local-regional control of disease and disease-free rates in patients treated with these regimens. Compare the acute and late toxicity of these regimens in these patients. Compare quality of life, perception of side effects, and performance status of patients treated with these regimens. Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions are independent prognostic markers in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor site (larynx vs other), nodal stage (N0 vs N1 or N2a or N2b vs N2c or N3), and Zubrod performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo standard fractionation radiotherapy 5 days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 22, and 43. Arm II: Patients undergo accelerated fractionation radiotherapy 5 days a week for 3.5 weeks and then twice a day, 5 days a week, for 2.5 weeks. Patients also receive cisplatin IV on days 1 and 22. Patients with biopsy-proven relapsed disease more than 3 months after completion of therapy undergo surgical resection of the primary tumor. Quality of life is assessed at baseline, during one of the last 2 weeks of treatment, at 3 and 12 months, and then annually for 4 years. Patients are followed at 6-8 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 720 patients (360 per treatment arm) will be accrued for this study within 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
743 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard fractionation RT + cisplatin
Arm Type
Other
Arm Description
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
Arm Title
Accelerated fractionation RT + cisplatin
Arm Type
Experimental
Arm Description
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
100 mg/m^2 intravenously on days 1, 22
Intervention Type
Radiation
Intervention Name(s)
Standard fractionation RT
Intervention Description
Radiation will be delivered in 2 Gy per fraction, five fractions a week. The primary tumor and clinically/radiologically involved nodes will receive 70 Gy in 7 weeks and uninvolved nodes will receive 50 Gy in 5 weeks. The anterior lower neck field will be treated with 2 Gy per fraction at 3-cm depth to a total dose of 50 Gy.
Intervention Type
Radiation
Intervention Name(s)
Accelerated fractionation radiation therapy
Intervention Description
Radiation to the initial target volume encompassing the gross and subclinical disease sites will be delivered in 1.8 Gy per fraction, five fractions a week to 54 Gy in 30 fractions over 6 weeks. At 32.4 Gy/18 Fx (i.e., latter part of week 4), the boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation of 1.5 Gy/Fx as second daily fraction (at least 6 h interval) for a total of 12 treatment days (18 Gy total). The primary tumor and clinically/radiologically involved nodes will receive 72 Gy in 42 fractions over 6 weeks and uninvolved nodes will receive 54 Gy in 6 weeks. Clinically/radiologically negative posterior neck should receive a minimum dose of 50.4 Gy at 3 cm. The anterior lower neck field will be treated with 1.8 Gy per fraction at 3-cm depth to a total dose of 50.4 Gy in 28 fractions in 5.6 weeks.
Intervention Type
Procedure
Intervention Name(s)
Conventional surgery for select patients
Intervention Description
Surgical removal (salvage resection) of the primary tumor should be performed if biopsy-proven cancer remains more than three months after completion of therapy. The nature of the surgical resection should be dictated by the extent of tumor at the initial evaluation. The operation should be conducted using accepted criteria for primary surgical treatment of the cancer. A planned neck dissection for patients with multiple neck nodes or with lymph nodes exceeding 3 cm in diameter (N2a, N2b, N3) is mandatory, regardless of the clinical and/or radiographic response. A neck dissection is required for patients with N1 disease if a palpable or worrisome radiographic abnormality persists in the neck six weeks after completion of therapy. Surgery should be performed within 2 weeks once the decision for neck dissection is made.
Primary Outcome Measure Information:
Title
Overall Survival (Percentage of Participants Alive)
Description
Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Time Frame
From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
Secondary Outcome Measure Information:
Title
Local-regional Failure (Percentage of Participants With Local-regional Failure)
Description
Local-regional failure time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), death (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Time Frame
From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
Title
Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]
Description
Local-regional failure time is defined as time from randomization to relapse/progression in the primary tumor or regional nodes (event), death due to study cancer or unknown causes (event), death due to other causes (competing event), distant metastasis (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Time Frame
From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
Title
Disease-free Survival (Percentage of Participants Alive Without Disease)
Description
Disease-free survival time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), distant metastasis (event), second primary tumor (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Time Frame
From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
Title
Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]
Description
Progression-free survival time is defined as time from randomization to relapse/progression in the primary site or regional nodes (event), distant metastasis (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Time Frame
From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
Title
Percentage of Participants With Toxicity Grade 3 or Higher
Description
Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data.
Time Frame
From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.
Title
Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year
Description
The PSS-HN is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet (this outcome measure), Public Eating, and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and one year calculated by use of area under the curve (AUC).
Time Frame
Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.
Title
PSS-HN Public Eating Score - AUC at One Year
Description
The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating (this outcome measure), and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC).
Time Frame
Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.
Title
PSS-HN Understandability of Speech Score - AUC at One Year
Description
The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating, and Understandability of Speech (this outcome measure). Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC).
Time Frame
Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.
Title
Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year
Description
The HNRQ is a patient-reported questionnaire administrated through a paper format; it measures radiation-related side effects and the overall well-being of head and neck cancer patients in the past week. The overall score is the mean of the 22 questions, with a range of 1 to 7. Higher scores indicate better quality of life. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and 1 year calculated by use of area under the curve (AUC).
Time Frame
Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.
Title
Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes
Time Frame
From randomization to date of death or last follow-up
Title
Correlation of COX-2 With Outcomes
Time Frame
From randomization to date of death or last follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0) No metastases below the clavicle or more distant by clinical exam or radiology PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 mg/dL Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal Renal Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Calcium normal Cardiovascular No symptomatic coronary artery disease (angina) No myocardial infarction within the past 6 months Other No other invasive malignancy within the past 3 years except nonmelanoma skin cancer No simultaneous primary tumors Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the head and neck except radioactive iodine therapy Surgery No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease No radical or modified neck dissection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phuc Felix Nguyen-Tan, MD
Organizational Affiliation
CHUM Hospital Notre Dame
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
Foundation for Cancer Research and Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
CCOP - Mayo Clinic Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Scottsdale Healthcare - Shea
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Providence Saint Joseph Medical Center - Burbank
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Saint Rose Hospital
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Valley Memorial Hospital
City
Livermore
State/Province
California
ZIP/Postal Code
94550
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Providence Holy Cross Cancer Center
City
Mission Hills
State/Province
California
ZIP/Postal Code
91346-9600
Country
United States
Facility Name
Highland General Hospital
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Summit Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Pomona Valley Hospital Medical Center
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Radiological Associates of Sacramento Medical Group, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Naval Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
J.C. Robinson, M.D. Regional Cancer Center
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
Memorial Hospital Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80217-3364
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
St. Francis Hospital
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States
Facility Name
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
21st Century Oncology - Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Shands Cancer Center at the University of Florida - Jacksonville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Baptist Cancer Institute - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Gulf Coast Cancer Treatment Center
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Georgia Cancer Center for Excellence at Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
John B. Amos Community Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Northwest Community Hospital
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Mount Sinai Hospital Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Cancer Care Center at Advocate Good Samaritan Hospital
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Facility Name
Alexian Brothers Cancer Care Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Ingalls Cancer Care Center at Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
St. John's Cancer Center at St. John's Medical Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
St. Francis Hospital and Health Centers
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Saint Joseph Regional Medical Center - Plymouth Campus
City
Plymouth
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Wendt Regional Cancer Center at Finley Hospital
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
Cancer Treatment Center at the Medical Center - Bowling Green
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
James Graham Brown Cancer Center at University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Baton Rouge General Regional Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Mary Bird Perkins Cancer Center - Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Cancer Center at Medical Center of Louisiana - New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
New Orleans Cancer Institute at Memorial Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
DeCesaris Cancer Institute at Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Union Hospital Cancer Center at Union Hospital
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Cancer Research Center at Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Hudner Oncology Center at Saint Anne's Hospital
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Cape Cod Hospital
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
South Suburban Oncology Center
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48100
Country
United States
Facility Name
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Great Lakes Cancer Institute at McLaren Regional Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Seton Cancer Institute - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48903
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Cancer Institute of Cape Girardeau
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Saint Louis University Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Washoe Cancer Services at Washoe Medical Center - Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cancer Institute of New Jersey at the Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
South Jersey Healthcare Regional Cancer Center
City
Millville
State/Province
New Jersey
ZIP/Postal Code
08332
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program - Marlton
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
City
Plattsburgh
State/Province
New York
ZIP/Postal Code
12901
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Randolph Hospital
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
City
Eden
State/Province
North Carolina
ZIP/Postal Code
27288
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wayne Radiation Oncology
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Annie Penn Cancer Center
City
Reidsville
State/Province
North Carolina
ZIP/Postal Code
27320
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
Country
United States
Facility Name
Wilson Medical Center
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Trinity Cancer Care Center
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Akron City Hospital at Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Aultman Hospital Cancer Center at Aultman Health Foundation
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710-1799
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
St. Rita's Medical Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Middletown Regional Hospital
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45044
Country
United States
Facility Name
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
City
Salem
State/Province
Ohio
ZIP/Postal Code
44460
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Cancer Treatment Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
LaFortune Cancer Center at St. John Health System
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center at St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Cancer Center at Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Mercy Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Mercy Hospital Cancer Center - Scranton
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18501
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Rose Ramer Cancer Clinic at Anderson Area Medical Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Bon Secours St. Francis Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Greenville Hospital System Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29304
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Harrington Cancer Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
Cottonwood Hospital Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84603
Country
United States
Facility Name
Dixie Regional Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Utah Cancer Specialists at UCS Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Rappahannock General Hospital
City
Kilmarnock
State/Province
Virginia
ZIP/Postal Code
22482
Country
United States
Facility Name
Naval Medical Center - Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708-2197
Country
United States
Facility Name
Veterans Affairs Medical Center - Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Massey Cancer Center at Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Community Memorial Health Center
City
South Hill
State/Province
Virginia
ZIP/Postal Code
23970-0090
Country
United States
Facility Name
North Star Lodge Cancer Center
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Washington Hematology - Oncology Specialists
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Schiffler Cancer Center at Wheeling Hospital
City
Wheeling
State/Province
West Virginia
ZIP/Postal Code
26003
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Mary's Hospital Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Holy Family Memorial Medical Center
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54221
Country
United States
Facility Name
Bay Area Cancer Care Center at Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Community Memorial Hospital
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
Facility Name
St. Mary's Cancer Center at Columbia St. Mary's Hospital - Milwaukee Campus
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Oconomowoc Memorial Hospital
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066-3896
Country
United States
Facility Name
All Saints Cancer Center at All Saints Healthcare
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States
Facility Name
Waukesha Memorial Hospital Regional Cancer Center
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22565003
Citation
Gillison ML, Zhang Q, Jordan R, Xiao W, Westra WH, Trotti A, Spencer S, Harris J, Chung CH, Ang KK. Tobacco smoking and increased risk of death and progression for patients with p16-positive and p16-negative oropharyngeal cancer. J Clin Oncol. 2012 Jun 10;30(17):2102-11. doi: 10.1200/JCO.2011.38.4099. Epub 2012 May 7.
Results Reference
background
Citation
Wuthrick EJ, Zhang Q, Machtay M, et al.: The influence of institutional head and neck cancer (HNC) clinical trial accrual on overall survival (OS): An analysis of RTOG 0129. [Abstract] J Clin Oncol 30 (Suppl 15): A-5530, 2012.
Results Reference
result
PubMed Identifier
20530316
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.
Results Reference
result
Citation
Ang K, Zhang Q, Wheeler RH, et al.: A phase III trial (RTOG 0129) of two radiation-cisplatin regimens for head and neck carcinomas (HNC): impact of radiation and cisplatin intensity on outcome. [Abstract] J Clin Oncol 28 (Suppl 15): A-5507, 2010.
Results Reference
result
Citation
Gillison ML, Harris J, Westra W, et al.: Survival outcomes by tumor human papillomavirus (HPV) status in stage III-IV oropharyngeal cancer (OPC) in RTOG 0129. [Abstract] J Clin Oncol 27 (Suppl 15): A-6003, 2009.
Results Reference
result
Citation
Ang K, Pajak T, Rosenthal DI, et al.: A phase III trial to compare standard versus accelerated fractionation in combination with concurrent cisplatin for head and neck carcinomas (RTOG 0129): report of compliance and toxicity. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-21, S12-13, 2007.
Results Reference
result
PubMed Identifier
31420360
Citation
Mell LK, Shen H, Nguyen-Tan PF, Rosenthal DI, Zakeri K, Vitzthum LK, Frank SJ, Schiff PB, Trotti AM 3rd, Bonner JA, Jones CU, Yom SS, Thorstad WL, Wong SJ, Shenouda G, Ridge JA, Zhang QE, Le QT. Nomogram to Predict the Benefit of Intensive Treatment for Locoregionally Advanced Head and Neck Cancer. Clin Cancer Res. 2019 Dec 1;25(23):7078-7088. doi: 10.1158/1078-0432.CCR-19-1832. Epub 2019 Aug 16.
Results Reference
derived
PubMed Identifier
30548235
Citation
Beitler JJ, Switchenko JM, Dignam JJ, McDonald MW, Saba NF, Shin DM, Magliocca KR, Cassidy RJ, El-Deiry MW, Patel MR, Steuer CE, Xiao C, Hudgins PA, Aiken AH, Curran WJ Jr, Le QT. Smoking, age, nodal disease, T stage, p16 status, and risk of distant metastases in patients with squamous cell cancer of the oropharynx. Cancer. 2019 Mar 1;125(5):704-711. doi: 10.1002/cncr.31820. Epub 2018 Dec 11.
Results Reference
derived
PubMed Identifier
25488965
Citation
Wuthrick EJ, Zhang Q, Machtay M, Rosenthal DI, Nguyen-Tan PF, Fortin A, Silverman CL, Raben A, Kim HE, Horwitz EM, Read NE, Harris J, Wu Q, Le QT, Gillison ML. Institutional clinical trial accrual volume and survival of patients with head and neck cancer. J Clin Oncol. 2015 Jan 10;33(2):156-64. doi: 10.1200/JCO.2014.56.5218. Epub 2014 Dec 8.
Results Reference
derived
PubMed Identifier
25366680
Citation
Nguyen-Tan PF, Zhang Q, Ang KK, Weber RS, Rosenthal DI, Soulieres D, Kim H, Silverman C, Raben A, Galloway TJ, Fortin A, Gore E, Westra WH, Chung CH, Jordan RC, Gillison ML, List M, Le QT. Randomized phase III trial to test accelerated versus standard fractionation in combination with concurrent cisplatin for head and neck carcinomas in the Radiation Therapy Oncology Group 0129 trial: long-term report of efficacy and toxicity. J Clin Oncol. 2014 Dec 1;32(34):3858-66. doi: 10.1200/JCO.2014.55.3925. Epub 2014 Nov 3.
Results Reference
derived

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Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

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