A Safety and Efficacy Study in Patients With Gastric Cancer
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating
the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced
gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be
randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm).
Patients will be stratified by number of metastatic sites (one vs. more than one), locally
advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or
non-measurable disease, and center.