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
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
Allocation: Randomized, Primary Purpose: Treatment
Hansjochen Wilke, MD
United States: Federal Government