A PHASE III INTERGROUP RANDOMIZED COMPARISON OF COMBINED MODALITY THERAPY FOR CARCINOMA OF THE ESOPHAGUS: HIGH-DOSE VS CONVENTIONAL-DOSE RADIATION THERAPY
OBJECTIVES: I. Compare, using a prospective controlled randomized study design, the survival
and failure patterns associated with conventional-dose radiotherapy and
fluorouracil/cisplatin (5-FU/CDDP) vs. high-dose radiotherapy and 5-FU/CDDP in patients with
esophageal cancer. II. Compare the tolerance and quality of life of patients receiving these
therapies.
OUTLINE: Randomized study. Arm I: Radiotherapy plus 2-Drug Combination
Chemotherapy/Radiosensitization. Tumor irradiation using megavoltage photons of at least 6
MV (electrons may be used if required to boost supraclavicular fossa dose); plus Cisplatin,
CDDP, NSC-119875; Fluorouracil, 5-FU, NSC-19893. High-dose radiotherapy. Arm II:
Radiotherapy plus 2-Drug Combination Chemotherapy/Radiosensitization. Tumor irradiation as
in Arm I; plus CDDP/5-FU. Conventional-dose radiotherapy.
PROJECTED ACCRUAL: Up to 298 patients will be entered over 4 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Bruce D. Minsky, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000064043
NCT00002631
June 1995
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
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 - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |