Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Cancer of the Esophagus
- Conditions
- Esophageal Cancer
- Registration Number
- NCT00002631
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not known whether high-dose radiation therapy is more effective than standard dose radiation therapy in treating cancer of the esophagus.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus high- or standard-dose radiation therapy in treating patients with cancer of the esophagus.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 298
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CentraCare Clinic
🇺🇸Saint Cloud, Minnesota, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
Saskatchewan Cancer Agency
🇨🇦Regina, Saskatchewan, Canada
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Geisinger Clinical and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States