Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer
A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
3 other identifiers
interventional
743
1 country
195
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 head-and-neck-cancer
Started Jul 2002
Longer than P75 for phase_3 head-and-neck-cancer
195 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 3, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedJuly 7, 2023
April 1, 2023
7.9 years
October 3, 2002
July 28, 2014
July 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (11)
Local-regional Failure (Percentage of Participants With Local-regional Failure)
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.
Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]
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.
Disease-free Survival (Percentage of Participants Alive Without Disease)
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.
Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]
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.
Percentage of Participants With Toxicity Grade 3 or Higher
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.
- +6 more secondary outcomes
Study Arms (2)
Standard fractionation RT + cisplatin
OTHERStandard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
Accelerated fractionation RT + cisplatin
EXPERIMENTALAccelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
Interventions
100 mg/m\^2 intravenously on days 1, 22
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.
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.
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.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- NRG Oncologycollaborator
Study Sites (195)
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, 85259, United States
Scottsdale Healthcare - Shea
Scottsdale, Arizona, 85260, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
Scottsdale, Arizona, 85260, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505, United States
Saint Rose Hospital
Hayward, California, 94545, United States
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, 90301, United States
Valley Memorial Hospital
Livermore, California, 94550, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, 92354, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804, United States
Providence Holy Cross Cancer Center
Mission Hills, California, 91346-9600, United States
Highland General Hospital
Oakland, California, 94602, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609, United States
Summit Medical Center
Oakland, California, 94609, United States
Pomona Valley Hospital Medical Center
Pomona, California, 91767, United States
Radiological Associates of Sacramento Medical Group, Inc.
Sacramento, California, 95815, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Naval Medical Center - San Diego
San Diego, California, 92134, United States
J.C. Robinson, M.D. Regional Cancer Center
San Pablo, California, 94806, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80217-3364, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19718, United States
St. Francis Hospital
Wilmington, Delaware, 19805, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
21st Century Oncology - Fort Myers
Fort Myers, Florida, 33901, United States
Shands Cancer Center at the University of Florida - Jacksonville
Gainesville, Florida, 32610, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
University of Florida Shands Cancer Center
Jacksonville, Florida, 32209, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, 32405, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322, United States
John B. Amos Community Cancer Center
Columbus, Georgia, 31904, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 31403, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Cancer Care Center at Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
Alexian Brothers Cancer Care Center
Elk Grove Village, Illinois, 60007, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
St. John's Cancer Center at St. John's Medical Center
Anderson, Indiana, 46016, United States
St. Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Saint Joseph Regional Medical Center - Plymouth Campus
Plymouth, Indiana, 46544, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, 52001, United States
Cancer Treatment Center at the Medical Center - Bowling Green
Bowling Green, Kentucky, 42101, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, 70806, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Cancer Center at Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, 70112, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Tulane Cancer Center
New Orleans, Louisiana, 70112, United States
New Orleans Cancer Institute at Memorial Medical Center
New Orleans, Louisiana, 70115, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Union Hospital Cancer Center at Union Hospital
Elkton, Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118, United States
Hudner Oncology Center at Saint Anne's Hospital
Fall River, Massachusetts, 02721, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
South Suburban Oncology Center
Quincy, Massachusetts, 02169, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48100, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48532, United States
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, 48532, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Seton Cancer Institute - Saginaw
Saginaw, Michigan, 48601, United States
St. John Macomb Hospital
Warren, Michigan, 48903, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Cancer Institute of Cape Girardeau
Cape Girardeau, Missouri, 63703, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
Saint Louis University Cancer Center
St Louis, Missouri, 63110, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Washoe Cancer Services at Washoe Medical Center - Reno
Reno, Nevada, 89502, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, 08103, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
South Jersey Healthcare Regional Cancer Center
Millville, New Jersey, 08332, United States
Fox Chase Virtua Health Cancer Program - Marlton
Mount Holly, New Jersey, 08060, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
Eden, North Carolina, 27288, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, 27401, United States
Annie Penn Cancer Center
Reidsville, North Carolina, 27320, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Wilson Medical Center
Wilson, North Carolina, 27893, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Trinity Cancer Care Center
Minot, North Dakota, 58701, United States
Akron City Hospital at Summa Health System
Akron, Ohio, 44304, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, 44710-1799, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428, United States
CCOP - Dayton
Dayton, Ohio, 45429, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Middletown Regional Hospital
Middletown, Ohio, 45044, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, 44460, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373, United States
Cancer Treatment Center
Wooster, Ohio, 44691, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
LaFortune Cancer Center at St. John Health System
Tulsa, Oklahoma, 74104, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Cancer Center at Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, 29621, United States
Bon Secours St. Francis Health System
Greenville, South Carolina, 29601, United States
Greenville Hospital System Cancer Center
Greenville, South Carolina, 29605, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29304, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232, United States
Harrington Cancer Center
Amarillo, Texas, 79106, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236, United States
Cottonwood Hospital Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84603, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Regional Medical Center
St. George, Utah, 84770, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Rappahannock General Hospital
Kilmarnock, Virginia, 22482, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, 23298-0037, United States
Community Memorial Health Center
South Hill, Virginia, 23970-0090, United States
North Star Lodge Cancer Center
Yakima, Washington, 98902, United States
Washington Hematology - Oncology Specialists
Yakima, Washington, 98902, United States
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, 26003, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
St. Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
Holy Family Memorial Medical Center
Manitowoc, Wisconsin, 54221, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051, United States
St. Mary's Cancer Center at Columbia St. Mary's Hospital - Milwaukee Campus
Milwaukee, Wisconsin, 53211, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295, United States
Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066-3896, United States
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, 53405, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
Related Publications (11)
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.
PMID: 22565003BACKGROUNDWuthrick 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.
RESULTAng KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.
PMID: 20530316RESULTAng 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.
RESULTGillison 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.
RESULTAng 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.
RESULTGharzai LA, Morris E, Schipper MJ, Kidwell KM, Nguyen-Tan PF, Rosenthal DI, Gillison ML, Jordan RC, Garden AS, Koyfman SA, Caudell JJ, Blakaj DM, Dunlap NE, Krempl GA, Longo JM, Jones CU, Gensheimer MF, Galloway TJ, DeMora L, Le QT, Shah JL, Suresh K, Mierzwa M. Treatment Interruption and Outcomes in Head and Neck Cancer: A Secondary Analysis of 3 Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2025 Dec 4:e254203. doi: 10.1001/jamaoto.2025.4203. Online ahead of print.
PMID: 41343184DERIVEDMell 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.
PMID: 31420360DERIVEDBeitler 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.
PMID: 30548235DERIVEDWuthrick 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.
PMID: 25488965DERIVEDNguyen-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.
PMID: 25366680DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Local-regional failure and disease-free survival were additionally analyzed with the definition of failure used in the Meta-Analysis of Radiotherapy in Carcinomas of Head and Neck (MARCH) Collaborative Group and the Meta-Analysis of Chemotherapy in Head and Neck Cancer (MACH-NC) Collaborative Group publications. These modified outcome measures are labeled "Alternate Definition".
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Phuc Felix Nguyen-Tan, MD
CHUM Hospital Notre Dame
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2002
First Posted
January 27, 2003
Study Start
July 1, 2002
Primary Completion
June 1, 2010
Study Completion
May 20, 2022
Last Updated
July 7, 2023
Results First Posted
August 15, 2014
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share