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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1
16 cycles of adjuvant chemotherapy with S-1 only
Cancer Hospital Chinese Acadamy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
disease-free survival
Time frame: 5 years
overall survival
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
Time frame: up to 5 years
Incidence of Treatment-Emergent Adverse Events [Safety]
The incidence of chemotherapy related adverse events in GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Nanjing General Hospital
Nanjing, Jiangsu, China
...and 5 more locations