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| Name | Class |
|---|---|
| Taiho Pharmaceutical Co., Ltd. | INDUSTRY |
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To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-1+oxaliplatin | Experimental | S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d oxaliplatin: 65mg/m2, D1,D8, 3weeks/cycle after 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles. |
|
| S-1+cisplatin | Active Comparator | S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d) cisplatin: 75mg/m2, D1, every 3 weeks After 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 | Drug | Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| replase free survival | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 6 months | |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shen Lin, professor | Contact | 010-88196561 | xiaotong10241@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| C103828 | titanium silicide |
| D000077150 | Oxaliplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| oxaliplatin | Drug | Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles |
|
| cisplatin | Drug | Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D017672 |
| Nitrogen Compounds |
| D017671 | Platinum Compounds |