[Process of making a protocol for advanced gastric cancer chemotherapy--using 5'-DFUR+CDDP as an example]

The process of making a protocol for advanced gastric cancer chemotherapy was reported by using an example of 5'-DFUR+CDDP. Patient selection and eligibility criteria, treatment method (Regimen A, 5'-DFUR 1,400 mg/m2/day, p.o. day 1-day 4/w, and CDDP 80 mg/m2 i.v. day 5 q 3w, Regimen B, 5'-DFUR 1,400 mg/m2/day p.o. day 1-day 4/2w and CDDP 80 mg/m2 i.v. day 5 q 4w), Response criteria (by the Japanese Research Society for Gastric Cancer: The general rules for the Gastric Cancer Study, published in June, 1993. 12th edition), registration method (prestratification by cancer spread in patient's body: abdominal localized type, liver metastatic and/or ascitic type, distant type), proposal of potential response rate, method of analysis of results (effective rate (ER), median survival rate (MST), one and two-year survival rate), toxicity and QOL evaluation etc, were discussed. In Regimen A, ER of complete case was 40% (95% CI 20.8-59.2%) and MST was 9.1 months: responder was 9.8 months and non-responder was 9.1 months. In Regimen B, ER of complete case was 36.4% (95% CI 22.7-50.1%) and MST was 9.1 months: responder was 15.3 months and non-responder was 7.5 months. In the evaluation of toxicity and QOL, Regimen B was prominently better than Regimen A. The results indicated that after careful consideration of the above-mentioned points, good-quality clinical trials must be performed.