The Effect of Electro-hyperthermia in Preoperative Radiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Single Institutional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- T stage (0 - 4), N (0 - 3) stage, tumor regression grade (0 - 4)
研究概览
简要总结
Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of complete resection and anal sphincter preservation. However, a treatment period of from 5 to 6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is confronting challenges for maximizing the therapeutic effect and minimizing the side effects. Electro-hyperthermia is appropriate treatment method to solve these kinds of problems. In this clinical trial, therapeutic effect of the high-frequency electro-hyperthermia is to be verified during preoperative radiotherapy for locally advanced rectal cancer. The ultimate goal is to establish a safe and effective treatment protocol.
详细描述
Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of complete resection and anal sphincter preservation. However, a treatment period of from 5 to 6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is confronting challenges for maximizing the therapeutic effect and minimizing the side effects. Electro-hyperthermia is appropriate treatment method to solve these kinds of problems. In this clinical trial, therapeutic effect of the high-frequency electro-hyperthermia is to be verified during preoperative radiotherapy for locally advanced rectal cancer. The endpoint of the trial is treatment safety and non-inferiority of tumor regression to conventional schedule of preoperative radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically-proven rectal adenocarcinoma within 15 cm from anal verge
- •Clinically T3-4 stage or positive lymph nodes
- •Performance status 0-2
- •Proper function of bone marrow, kidney, and liver
排除标准
- •Past disease history of rectum
- •Hereditary colorectal cancer
- •Chronic inflammatory bowel disease
- •Bower stenosis
- •Active infection
- •Myocardial infarction, uncontrolled arrhythmia, angina pectoris, or cardiac insufficiency within 6 months
- •Pregnancy, nursing
- •Unresected contemporary colon cancer
- •Thermal hypersensitivity
- •Too much subcutaneous fat in the abdominal and pelvic area
研究组 & 干预措施
Electro-hyperthermia plus radiation
External beam radiation 40 Gy with 20 fractions (4 weeks) Electro-hyperthermia twice a week, one hour for each session
干预措施: Electro-hyperthermia (Device)
结局指标
主要结局
T stage (0 - 4), N (0 - 3) stage, tumor regression grade (0 - 4)
时间窗: 3 months after curative surgery by surgical pathology report
surgical pathology report
次要结局
- Treatment toxicity (grade 0 - 5)(5 years after curative surgery by clinical assessments)