Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating
the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared
with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with
chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A),
S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced
distribution of patients to each arm according to following stratifications, performance
status (0, 1, or 2), the number of metastatic sites (1 vs >1), prior gastrectomy, and center.