NCT01106066终止1 期
A Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MTD/pathologic CR
研究概览
简要总结
To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma ③ Localized gastric cancer of clinical stage (T2N(+), T3/T4)
- •ECOG performance status of 0 to 1 ⑤ Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min ⑥ Written informed consent form
排除标准
- •T1 (regardless of N stage), T2N0
- •M1 ③ Peritoneal seeding ④ Uncontrolled medical condition
研究组 & 干预措施
S-1/oxaliplatin/RT
Experimental
Radiotherapy + 4 dose levels of oxaliplatin/S-1
干预措施: Oxaliplatin, S-1, radiotherapy (Drug)
结局指标
主要结局
MTD/pathologic CR
时间窗: at the time of surgery
次要结局
未报告次要终点
研究者
Won Ki Kang
Professor
Samsung Medical Center
研究点 (1)
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