Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Cancer of the Esophagus
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|ClinicalTrials.gov Identifier: NCT00002631|
Recruitment Status : Completed
First Posted : August 31, 2004
Last Update Posted : November 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: chemotherapy Drug: cisplatin Drug: fluorouracil Radiation: low-LET electron therapy Radiation: low-LET photon therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||298 participants|
|Official Title:||A PHASE III INTERGROUP RANDOMIZED COMPARISON OF COMBINED MODALITY THERAPY FOR CARCINOMA OF THE ESOPHAGUS: HIGH-DOSE VS CONVENTIONAL-DOSE RADIATION THERAPY|
|Study Start Date :||June 1995|
|Actual Primary Completion Date :||September 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002631
|Study Chair:||Bruce D. Minsky, MD||Memorial Sloan Kettering Cancer Center|
|Study Chair:||Thomas M. Pisansky, MD||Mayo Clinic|
|Study Chair:||James A. Martenson, MD||Mayo Clinic|