NCT00122291Unknown2 期
A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- safety
研究概览
简要总结
The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.
详细描述
The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal 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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy - proven rectal cancer
- •Transmural rectal wall invasion
- •Karnofsky performance status >70
- •Normal bone marrow, liver and kidney function
排除标准
- •Distant metastases
- •Prior pelvic radiation
- •Inflammatory bowel disease
- •Severe ischemic heart disease
- •Anticoagulant therapy
- •Pregnancy
结局指标
主要结局
safety
response
次要结局
未报告次要终点
研究者
研究点 (2)
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