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The optimal regimen for adjuvant treatment has not been established in GC yet. We plan to compare TS-1, TS-1/oxaliplatin with or without RT in D2 resected gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles |
|
| Arm B | Active Comparator | {S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles |
|
| Arm C | Active Comparator | {S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 weeks} x 2 cycles → S-1 40mg BID (2weeks - 1week off - 2weeks)+ RT 45 Gy (5weeks) → Rest for 4 weeks → {S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 weeks} x 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-1, oxaliplatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the study is disease-free survival (DFS). | 3-year |
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Inclusion Criteria:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| 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 |
|---|---|
| C103828 | titanium silicide |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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