Trials / Completed
CompletedNCT00002631
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Cancer of the Esophagus
A PHASE III INTERGROUP RANDOMIZED COMPARISON OF COMBINED MODALITY THERAPY FOR CARCINOMA OF THE ESOPHAGUS: HIGH-DOSE VS CONVENTIONAL-DOSE RADIATION THERAPY
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 298 (estimated)
- Sponsor
- Radiation Therapy Oncology Group · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | chemotherapy | |
| DRUG | cisplatin | |
| DRUG | fluorouracil | |
| RADIATION | low-LET electron therapy | |
| RADIATION | low-LET photon therapy |
Timeline
- Start date
- 1995-06-01
- Primary completion
- 1999-09-01
- First posted
- 2004-08-31
- Last updated
- 2013-11-19
Locations
18 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00002631. Inclusion in this directory is not an endorsement.