NCT03428867已完成不适用
Phase II Studie Zur Neoadjuvanten Trimodalen Hyperthermen Radiochemotherapie Des Tief Sitzenden Rektumskarzinoms im Stadium UICC II + III
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- remission
研究概览
简要总结
goal of this study is to check the effecivity, feasibility and toxicity of the chemoradiotherapy and hyperthermia
详细描述
Radiation: 5x1,8Gy until 50,4 Gy Hyperthermia: 2x/week
Chemotherapy:
neoadjuvant= day 1-5 and day 29-33 5FU 1000mg/m2 adjuvant = 4 Cycles 5FU 500mg/m2 all 4 weeks
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •adenocarcinoma until 10 cm until ano UICC II+III 18-80 years old ECOG PS 0-2 Informed Consent
排除标准
- •cardiac insufficiency last 6 month heartattack nodal AV pressure III° hip prothesis cardiac pacemaker others contraindikations against the therapie radiation of pelvis chronic gestrointestinal desaese gestation or lactation previous radiotion pelvis previous Chemotherapie second carcinoma beside baslioma infiltation in analarea
结局指标
主要结局
remission
时间窗: 5 years
次要结局
未报告次要终点
研究者
Prof. Dr. med. Daniel Zips
Prof.Dr. med.
University Hospital Tuebingen
研究点 (1)
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