Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- local and systemic recurrence rate
研究概览
简要总结
The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.
详细描述
The treatment group comprises patients with locally advanced rectal cancer who were operated on in the 1st Department of General Surgery, Jagiellonian University, Cracow. The data on survival has been systematically collected using national census registry. Patients are qualified to preoperative radiotherapy 5x5 Gy and then randomly assigned to subgroups with different time interval between radiotherapy and surgery: one subgroup consists of patients operated on 7-10 days after the end of irradiation, the second subgroup consists of patients operated on after 4-5 weeks. Both should be homogenous in sex, age, cancer stage and localization, distal and circumferential resection margins, number of resected lymph nodes. 3D endorectal ultrasound and endorectal ultrasound with SonoVue are performed to assess the tumor before and after preoperative radiotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed rectal cancer
- •tumor localised in middle or lower rectum
- •age > 18 years
- •locally advanced cancer
排除标准
- •previous pelvis radiotherapy
- •lack of patient's consent
- •lack of possibility to begin radiotherapy during 14 days after inclusion to the study
研究组 & 干预措施
Short time interval
Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy.
干预措施: Preoperative radiotherapy (Radiation)
Short time interval
Patients operated on 7-10 days after completing preoperative radiotherapy 5x5Gy.
干预措施: Surgery (Procedure)
Long time interval
Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy.
干预措施: Preoperative radiotherapy (Radiation)
Long time interval
Patients operated on 4-5 weeks after completing preoperative radiotherapy 5x5Gy.
干预措施: Surgery (Procedure)
结局指标
主要结局
local and systemic recurrence rate
时间窗: 5 years
Rate of local and sytemic recurrences in patients included to the protocol.
次要结局
- overall survival(5 years)
- downstaging of rectal cancer(1 month)
- radical resections rate (R0)(1 month)
- sphincter saving (sparing) procedures(1 month)
研究者
Radoslaw Pach, MD, PhD
Assisstant Professor
Jagiellonian University