Preoperative Radiochemotherapy With Concurrent Deep Regional Hyperthermia for Locally Advanced Rectal Cancer. A Prospective Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Pathological complete response rate
研究概览
简要总结
The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Congestive heart failure (NYHA III/IV)
- •History of myocardial infarction within the last 6 months.
- •AV Block III
- •Total hip replacement or major metal pelvic implants
- •Cardiac pacemaker
- •Contraindications for radiochemotherapy
- •Contraindications for surgical tumor resection
- •Previous pelvic radiotherapy or chemotherapy
- •Active chronic inflammatory bowel disease
- •Collagenosis
- •Congenital diseases with increased radiosensitivity
- •Pregnancy or breastfeeding
- •Secondary malignancies other than locally controlled basalioma or in-situ carcinomas Infiltration of the anal canal
研究组 & 干预措施
RtChx + Hyperthermia
Radiotherapy: 5 x 1,8 Gy/Week, cumulative dose 50,4 Gy (ICRU) Chemotherapy: 5-fluorouracil d1-5 and d29-d33 Deep regional hyperthermia: 2x/week
干预措施: Radiotherapy (Radiation)
RtChx + Hyperthermia
Radiotherapy: 5 x 1,8 Gy/Week, cumulative dose 50,4 Gy (ICRU) Chemotherapy: 5-fluorouracil d1-5 and d29-d33 Deep regional hyperthermia: 2x/week
干预措施: Deep regional hyperthermia (Other)
RtChx + Hyperthermia
Radiotherapy: 5 x 1,8 Gy/Week, cumulative dose 50,4 Gy (ICRU) Chemotherapy: 5-fluorouracil d1-5 and d29-d33 Deep regional hyperthermia: 2x/week
干预措施: Chemotherapy (5-Fluorouracil) (Drug)
结局指标
主要结局
Pathological complete response rate
时间窗: After surgical resection (4-6 weeks after last radiotherapy fraction)
次要结局
- post operative morbidity(3 years)
- Number of hyperthermia treatments(At completion of hyperthermic radiochemotherapy)
- Locoregional progression free survival(3 years)
- Disease free survival(3 years)
- Distant metastases free survival(3 years)
- Overall survival(3 years)
- Acute and chronic treatment related toxicity, according to CTC criteria(3 years)