PHASE III INTERGROUP TRIAL OF SURGERY FOLLOWED BY (1) RADIOTHERAPY VS. (2) RADIOCHEMOTHERAPY FOR RESECTABLE HIGH RISK SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
OBJECTIVES: I. Evaluate locoregional control rates, patterns of first failure, and overall
and disease-free survival in patients with advanced squamous cell carcinoma of the head and
neck at high risk of locoregional recurrence who are treated postoperatively with concurrent
cisplatin and radiotherapy. II. Compare the toxicity of concurrent chemoradiotherapy vs.
radiotherapy alone in the postoperative setting.
OUTLINE: Randomized study. Arm I: Radiotherapy. Involved-field irradiation using Co60, 1-6
MV photons, or electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation
as in Arm I; plus Cisplatin, CDDP, NSC-119875.
PROJECTED ACCRUAL: 438 patients will be entered over approximately 5 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Jay S. Cooper, MD, FACR, FACRO
Study Chair
New York University School of Medicine
United States: Federal Government
CDR0000064279
NCT00002670
September 1995
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |
CCOP - Sooner State | Tulsa, Oklahoma 74136 |