Gastric Cancer Clinical Trial
Official title:
A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers
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.
OBJECTIVES:
- 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.
;
Allocation: Randomized, Primary Purpose: Treatment
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