Overview
The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.
Description
The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.
Eligibility
Inclusion Criteria:
- sign written informed consent form
- age ≥ 18 years, ≤69 years
- ECOG status: 0~2
- pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version)
- negative peritoneal cytology
- underwent curative distal gastrectomy with D2 lymph node dissection
- no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
- adequate organ function as defined below: Hematologic ANC ≥ 2109/L, Platelets ≥ 100109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.
Exclusion Criteria:
- be enrolled in other clinical trials
- underwent prior antitumor treatment
- allergic reaction to S-1 or oxaliplatin
- abnormal GI tract function
- female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy
- other situation to be judged not adaptive to the study by investigators