NCT00174616已完成2 期
Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- MRI staging and TME surgery
研究概览
简要总结
Primary objective:
- Pathological complete response (ypT0N0) rate
Secondary objectives:
- Histopathological R0 resection rate
- Pathological downstaging (ypT0-T2N0) rate
- One month surgical complication rate
- Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
- Safety
- Local and distant recurrence rates
- Progression-free survival
- Overall survival
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single arm
Experimental
干预措施: Oxaliplatin, capecitabine, radiotherapy (Drug)
结局指标
主要结局
MRI staging and TME surgery
时间窗: within 4 - 6 weeks after completion XELOX-RT
次要结局
- Measure safety - NCI-CTC version 2(from baseline to end of study)
研究者
研究点 (1)
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