Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, chemotherapy, D2 resection, S-1
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1 plus oxaliplatin Type: Drug
Name: S-1 single Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- informed consensus of patients

- be able to receive oral administration

- from 18 to 70 years old

- be proven to be primary adenocarcinoma of gastric cancer and staged II or III by pathological evidences

- without other chemotherapy and/or radiation against to the disease

- normal function of other organs including heart,liver ,kidney and so on

- Eastern Cooperative Oncology Group performance status:0~2

Exclusion Criteria:

- history of other malignancy

- allergic reaction to S-1 or oxaliplatin

- be enrolling in other clinical trials

- abnormal GI tract function

- dysfunction of other organs

- 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
Locations
the central hospital of Chaozhou
Chaozhou, Guangdong, China
Status: Recruiting
Contact: Zhaoxiong Xie - 13502633570 - xzx60111@126.com
the 1st people's hospital of Foshan
Foshan, Guangdong, China
Status: Recruiting
Contact: Wei Wang, ph.d - 18666392971 - wangwei@fsyyy.com
cancer center of Guangzhou medical college
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Haiying Liu, ph.d - 13725182319 - gzdlhy@yahoo.com.cn
cancer center of Sun yat-sen University
Guangzhou, Guangdong, China
Status: Recruiting
Contact: zhiwei zhou, PH. D - 1390222289 - zhouzhw@sysucc.org.cn
Guangdong Traditional Medical Hospital
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Jin Wan, ph.d - 13602838202 - reiqiwj@yahoo.cn
the 1st affliated hospital of Guangdong pharmacuetic college
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Weibin Zhang, ph.d - 13002033388 - zhangwb_0001@163.com
the 1St Affliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Jian Lei, ph.d - 13903070123 - drlei@21cn.com
the 6th affliated hospital of Sun-yat-sen University
Guangzhou, Guangdong, China
Status: Recruiting
Contact: junsheng peng, ph.d - 13527618858 - pengjunsheng@tom.com
the 1st hospital of Shantou University
Shantou, Guangdong, China
Status: Recruiting
Contact: Wei Li, ph.d - 13802716679 - lwmail@medmail.com.cn
the cental hospital of Shantou
Shantou, Guangdong, China
Status: Recruiting
Contact: Zhiyong Wu, ph.d - 13502953050 - stwuzy@163.com
YUE-BEI people's hospital
Shaoguan, Guangdong, China
Status: Recruiting
Contact: Tao Zhang - 13500206389 - ybyyzhangtao@126.com
the 2nd people's hospital of Shenzhen
Shenzhen, Guangdong, China
Status: Recruiting
Contact: Kai Zheng, ph.d - 13902489160 - zkzk1212@163.com
the 5th hospital of Sun-yat-sen University
Zhuhai, Guangdong, China
Status: Recruiting
Contact: Bingzong Hou, ph.d - 13172660798 - houbingzong@163.com
Start Date
September 2011
Completion Date
June 2018
Sponsors
Sun Yat-sen University
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page