Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer
- Registration Number
- NCT02867839
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 29
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A: postoperative Oxaliplatin plus S-1 Oxaliplatin plus S-1 Patients in arm A will receive standard distal gastrectomy with D2 lymphadenectomy first, and 8 cycles of adjuvant Oxaliplatin plus S-1 (SOX) later. Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3W S-1: 40\~60mg bid, po, d1\~14, q3W (6 months) B: postoperative S-1 only S-1 only Patients in arm B will receive standard distal gastrectomy with D2 lymphadenectomy first, and 16 cycles of adjuvant S-1 later. S-1: 40\~60mg bid, po, d1\~14, q3W (12 months)
- Primary Outcome Measures
Name Time Method disease-free survival 5 years
- Secondary Outcome Measures
Name Time Method overall survival up to 5 years To evaluate the 1-year, 3-year and 5-year overall survival of GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX
Incidence of Treatment-Emergent Adverse Events [Safety] 1 year The incidence of chemotherapy related adverse events in GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX
Trial Locations
- Locations (15)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Xuanwu Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital Chinese Acadamy of Medical Sciences
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Daliang Medical University
🇨🇳Daliang, Liaoning, China
The Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Nanjing General Hospital
🇨🇳Nanjing, Jiangsu, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China