Gastric Cancer Clinical Trial
Official title:
RANDOMIZED PHASE II STUDY OF A WEEKLY 24H-INFUSION OF HIGH-DOSE 5-FU PLUS OR MINUS FOLINIC ACID (HD-FU/FA) VERSUS HD-FU/FA PLUS BIWEEKLY CISPLATIN VERSUS FAMTX (5-FU/ADRIAMYCIN/METHOTREXATE) IN ADVANCED GASTRIC CANCER, AN EORTC/AIO INTERGROUP TRIAL
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug and giving higher doses may kill
more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of high-dose chemotherapy in
treating patients with advanced stomach cancer.
OBJECTIVES: I. Determine the response rates in patients with advanced gastric cancer treated
with high-dose fluorouracil (5-FU) with vs without high-dose leucovorin (CF) vs high-dose
5-FU/CF/cisplatin. II. Determine the toxic effects of these regimens in these patients. III.
Assess the symptomatic improvement in these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, WHO performance status (0 or 1 vs 2), and disease stage (metastatic vs
locally advanced). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive
fluorouracil (5-FU) IV over 24 hours weekly for 6 weeks. Arm II: Patients receive leucovorin
calcium (CF) IV over 2 hours followed by 5-FU IV over 24 hours weekly for 6 weeks. Arm III:
Patients receive CF and 5-FU as in arm II and cisplatin IV over 1 hour on days 1, 15, and
29. Treatment repeats every 7 weeks for a maximum of 4 courses in the absence of
unacceptable toxicity or disease progression. Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 65-135 patients (21-45 per arm) will be accrued for this
study.
;
Allocation: Randomized, Primary Purpose: Treatment
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