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Brief Title: Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
Official Title: A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
Study ID: NCT01795027
Brief Summary: Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as adjuvant chemotherapy after D2 resection in patients with gastric cancer. Patients and methods: In this study , patients with histologically confirmed gastric cancer who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized 1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40\~60mg twice everyday for 14 days in a 21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end of the 1st year postoperatively(SOX) , or TS-1 single 40\~60mg twice everyday for 14 days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is overall survival (OS), and secondary end point is disease free survival(DFS) and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
the central hospital of Chaozhou, Chaozhou, Guangdong, China
the 1st people's hospital of Foshan, Foshan, Guangdong, China
cancer center of Guangzhou medical college, Guangzhou, Guangdong, China
cancer center of Sun yat-sen University, Guangzhou, Guangdong, China
Guangdong Traditional Medical Hospital, Guangzhou, Guangdong, China
the 1st affliated hospital of Guangdong pharmacuetic college, Guangzhou, Guangdong, China
the 1St Affliated Hospital of Guangzhou Medical College, Guangzhou, Guangdong, China
the 6th affliated hospital of Sun-yat-sen University, Guangzhou, Guangdong, China
the 1st hospital of Shantou University, Shantou, Guangdong, China
the cental hospital of Shantou, Shantou, Guangdong, China
YUE-BEI people's hospital, Shaoguan, Guangdong, China
the 2nd people's hospital of Shenzhen, Shenzhen, Guangdong, China
the 5th hospital of Sun-yat-sen University, Zhuhai, Guangdong, China
Name: Zhiwei Zhou, PHD
Affiliation: SunYat-sen University
Role: STUDY_CHAIR