Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 547
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is disease-free survival (DFS).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven gastric or gastroesophageal adenocarcinoma
- •≥ D2 lymph node dissection, curative gastrectomy
- •Stage II, III (AJCC 2010) with any N (any stage with N0 will be excluded)
- •No distant metastasis
- •Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl, transfusion allowed)
- •Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
- •liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
- •Written informed consent
- •Possible oral intake (food, drug)
排除标准
- •Subjects presenting with any of the following will not be included in the study
- •Active infection requiring antibiotics
- •Pregnant, lactating women
- •Concurrent systemic illness not appropriate for chemotherapy
- •Resection margin (+) at permanent pathology
- •Pathologic stage I or IV (Ia or Ib according to AJCC 2010)
- •Inadequate surgery including D0, D1 resection, dissected LNs less than 12
- •Paraaortic lymph node (+), pathologically proven
- •women of potential childbearing not employing adequate contraception
研究组 & 干预措施
Arm A
S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles
干预措施: TS-1, oxaliplatin (Drug)
Arm B
{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles
干预措施: TS-1, oxaliplatin (Drug)
Arm C
{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
干预措施: TS-1, oxaliplatin (Drug)
结局指标
主要结局
The primary endpoint of the study is disease-free survival (DFS).
时间窗: 3-year
次要结局
未报告次要终点
研究者
Won Ki Kang
Professor
Samsung Medical Center