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The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug:S-1:80mg/m2;oxaliplatin 130mg/m2 | Experimental | Drug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy |
|
| surgery | No Intervention | Procedure/Surgery: Gastrectomy with D2 dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: S-1 and oxaliplatin | Drug | Drug:S-1:80mg/m2;oxaliplatin 130mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| response rate | 3 months |
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Inclusion Criteria:
DISEASE CHARACTERISTICS:
Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
Age:20 to 75
Performance status:ECOG 0-2
Life expectancy:Not specified
Hematopoietic:WBC 4,000-12,000/mm^3;Granulocyte count ≥ 2,000/mm^3;Platelet count ≥ 100,000/mm^3;Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L;Bilirubin ≤ 1.5 mg/dL
Adequate organ function
Able to swallow oral medication
Written informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| L Chen, MD | Contact | 86-10-66938028 | litbj301@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | 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) |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |