Preoperative Short-course Radiotherapy With Local Boost Versus Conventional Preoperative Short-course Radiotherapy for Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- pathological complete remission rate
研究概览
简要总结
A randomized trial comparing weather preoperative short-course radiotherapy with local boost is better than conventional preoperative short-course radiotherapy for local advanced rectal cancer.
详细描述
The study plans to recruit 100 patients,randomized into study group and control group,patients in study group are given the dose of PTV(planned target volume)-CTV(clinical target volume) 25Gy/5F with a local boost of PTV-GTV(gross tumour volume) 30Gy/5F；patients in control group are given the dose of PTV-CTV 25Gy/5F without a local boost. The other inventions are the same during the whole treatment,after the radiotherapy,they will receive a surgery under TME((total mesorectal excision) principal.Comparing the toxicity of radiotherapy, R0 resection rate,pathological complete remission rate, complications of operation and sphincter retention rate of these two groups to find out weather local boost bringing benefits to patients with local advanced rectal cancer.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Local advanced rectal cancer (TNM Stage ：T3-4NxM0 )diagnosed by biopsy and MRI or Endoscopic ultrasonography .
- •distance between tumour and anal edge ≤12cm.
- •PS（(Performance Status） score 0-2 or Karnofsky score≥
- •liver and kidney functions are normal.
- •without any treatment before inclusion.
排除标准
- •metastasis
- •combined with other severe diseases，such as other kind of cancer ,COPD,myocardial infarction,ect.
- •include in other clinical trails.
结局指标
主要结局
pathological complete remission rate
时间窗: 4 weeks after the surgery
次要结局
- disease free survival(From date of randomization until the date of first documented progression，assessed up to 60 months)
- sphincter retention rate(4 weeks after the surgery)
- toxicity of radiotherapy based on the CTCAE v3.0 (common terminology criteria for adverse events，CTCAE v3.0)(up to 60 months)
研究者
Zhou Fuxiang
professor
Zhongnan Hospital