Phase II study of protracted infusional 5-fluorouracil combined with cisplatinum for advanced gastric cancer: report from the Japan Clinical Oncology Group (JCOG).

A phase II study of protracted infusional 5-fluorouracil (5FU) combined with cisplatin (CDDP) was conducted in patients with advanced gastric carcinoma. 55 previously untreated patients, including 40 patients with measurable disease, were treated with 5FU (800 mg/m2, days 1-5, protracted infusion) and CDDP (20 mg/m2, days 1-5, drip infusion). Objective tumour responses were observed in 17/40 (43%) patients with measurable disease. Median survival was 7 months. WHO grade 3 or 4 leucopenia occurred in 10/55 patients (18%) and grade 3/4 thrombocytopenia was observed in 4 patients (7%). A randomised trial including this regimen is now underway in a JCOG study.

RCT Entities:   Population Interventions Outcomes