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An Open-label Randomized Multi-center Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer (SOLAR)
The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.
Details
| Lead sponsor | Taiho Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 711 |
| Start date | 2014-12 |
| Completion | 2020-05 |
Conditions
- Gastric Cancer
Interventions
- TAS-118 plus Oxaliplatin
- S-1 plus Cisplatin
Primary outcomes
- Overall Survival — A survival follow-up was required every 12 weeks from the date of randomization to the date of death from any cause, whichever came first, assessed up to 38 months.
The primary endpoint was OS, which was defined as the time from the date of randomization to the date of death from any cause. Surviving patients were censored at the cutoff date or last contact date if lost to follow-up, or upon withdrawal of consent.
Countries
Japan, South Korea