Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery
RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel 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. Cisplatin and paclitaxel may make the tumor cells more sensitive to radiation therapy and may kill any tumor cells remaining after surgery.
PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and radiation therapy with or without fluorouracil in treating patients who have stage IB, stage IIB, or stage IIIB stomach cancer that has been removed during surgery.
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers|
|Study Start Date:||May 2001|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
- Compare the 2-year disease-free survival in patients with resected stage IB-IIIB gastric cancer treated with cisplatin, paclitaxel, and radiotherapy with or without fluorouracil vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116 (RTOG 90-18). (Arm I closed to accrual as of 6/18/03.)
- Compare the safety and success of these regimens vs therapy in the intergroup adjuvant study.
- Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the intergroup study.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more). Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of 6/18/03.)
- Arm I (closed to accrual as of 6/18/03): Patients receive fluorouracil IV continuously and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on days 1 and 29.
At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.
- Arm II: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on days 1 and 29.
At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011960
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|Study Chair:||David Paul Kelsen, MD||Memorial Sloan Kettering Cancer Center.|