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Phase III Trial of 3-weekly vs. 5-weekly Schedule of S-1 Plus Cisplatin Combination Chemotherapy for First Line Treatment of Advanced Gastric Cancer.
The urgent need for a new effective therapy with better safety profile for the metastatic gastric cancer patients and promising results observed so far in the studies with S-1 plus cisplatin combination in advanced gastric cancer (AGC) strongly warrants the comparison of a 3-weekly schedule to a 5-weekly schedule of S-1 plus cisplatin as a standard regimen in the first-line treatment for AGC patients. The objectives of this study are to compare a 3-weekly schedule to a 5-weekly schedule of S-1 plus Cisplatin combination in terms of efficacy, quality of life and safety in patients with previously untreated advanced or recurrent unresectable gastric cancer. Primary endpoint is progression-free survival. This is an open label, randomized, multi-center, non-inferiority/superiority (of 3-weekly regimen over 3-weekly regimen) hybrid study.
Details
| Lead sponsor | Asan Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 625 |
| Start date | 2009-01 |
| Completion | 2013-05 |
Conditions
- Advanced Gastric Cancer
Interventions
- S-1 and cisplatin
- S-1 and cisplatin
Primary outcomes
- progression-free survival — accrual of patients for 36 months, followup of the last patient for 12 months
Countries
South Korea