KCT0003993
Recruiting
未知
Phase III Randomized Trial of Adjuvant Chemotherapy with TS-1 vs TS-1/oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samsung Medical Center
- Enrollment
- 900
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Histologically proven gastric or gastroesophageal adenocarcinoma
- •2\)\= D2 lymph node dissection, curative gastrectomy
- •3\)Stage II, III (AJCC 2010\) with any N (any stage with N0 will be excluded)
- •4\)Age \> 19
- •5\)ECOG 0\-2
- •6\)No distant metastasis
- •7\)Adequate bone marrow functions (ANC \= 1,500/ul, blood platelet \= 100,000/ul, hemoglobin \= 9\.0g/dL, transfusion allowed)
- •8\)Adequate renal functions(serum creatinine \= 1\.5mg/?)
- •9\)liver functions (serum bilirubin \= 1\.5mg/?, AST/ALT \= 3 times(normal value)
- •10\)Written informed consent
Exclusion Criteria
- •1\)Active infection requiring antibiotics
- •2\)Pregnant, lactating women
- •3\)Concurrent systemic illness not appropriate for chemotherapy
- •4\)Resection margin (\+) at permanent pathology
- •5\)Pathologic stage I or IV (Ia or Ib according to AJCC 2010\)
- •6\)Inadequate surgery including D0, D1 resection, dissected LNs less than 12
- •7\)Paraaortic lymph node (\+), pathologically proven
- •8\)women of potential childbearing not employing adequate contraception
Outcomes
Primary Outcomes
Not specified
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