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| ID | Type | Description | Link |
|---|---|---|---|
| ZHOUZHIWEI | Registry Identifier | ZZHIWEI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-1 plus Oxaliplatin | Experimental | 6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection |
|
| S-1 single | Active Comparator | S-1 40~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 plus oxaliplatin | Drug | 6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | 3 year | |
| Number of Participants with Adverse Events | 5 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiwei Zhou, PHD | SunYat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the central hospital of Chaozhou | Chaozhou | Guangdong | China | |||
| the 1st people's hospital of Foshan |
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| S-1 single | Drug | 16 courses S-1 single after d D2 resection |
|
|
| 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 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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