KCT0003993招募中未知
Phase III Randomized Trial of Adjuvant Chemotherapy with TS-1 vs TS-1/oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
- •11)Possible oral intake (food, drug)
排除标准
- •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
研究者
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