drugset / Trial / NCT03941561
S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC）
RandomizedParallel-groupOpen-labelTreatment
Summary
The study aims to compare the efficacy and safety of S-1 for 9 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer. Hypothesis: For gastric patients after D2 resection, S-1 for 9 months shows non-inferiority to S-1 for 1 year in disease-free survival(DFS), overall survival (OS) and safety.
Timeline
- Start
- 2019-01-01
- Primary completion
- 2022-01-01
- Completion
- 2027-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S-1 | Small molecule | 80 mg | — |
| Subject | S-1 | Small molecule | 120 mg | — |