NCT00597311Unknown3 期
Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 5 years overall and disease free survival
研究概览
简要总结
Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge
- •less than 80 years old
- •no other cancer during 5 years period
- •compensate cardiovascular, pulmonary, hepatic and renal functions.
排除标准
- •stage I or IV rectal cancer
- •other cancer in 5 years period
- •radiotherapy or chemotherapy in anamnesis
- •not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
- •pregnancy or baby feeding
研究组 & 干预措施
1
Experimental
preoperative short term radiation group 5x5 Gy and surgery after 6 weeks
干预措施: radiotherapy (Radiation)
2
Experimental
preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.
干预措施: radiotherapy (Radiation)
结局指标
主要结局
5 years overall and disease free survival
时间窗: 5 years
recurrence rate
时间窗: 5 years
次要结局
- pathological "complete response" and downstaging rates(5 years)
- Impact on sphincter sparing operation rates(5 years)
- morbidity and mortality rates(5 years)
- Impact on quality of surgical resection(5 years)
研究者
研究点 (1)
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