Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer

A Randomized, Multicentral, Controlled, Phase III Study to Compare Adjuvant Chemotherapy With S-1 Plus Oxaliplatin to S-1 Alone After Curative Distal Gastrectomy in Locally Advanced Gastric Cancer

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.

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.

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 ≥ 2*109/L, Platelets ≥ 100*109/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