Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- acceptation rate of the entire sequence by eligible patients
研究概览
简要总结
The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.
详细描述
The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.
It is based on a structured clinical and radiological pathway for patients, using diffusion MRI and F misonidazole PET.
Validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •locally advanced (≥T3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge.
排除标准
- •synchonous metastatis
- •previous malignant tumour
- •previous radiotherapy/ chemotherapy
- •performance status WHO>2
- •contraindication to 5 FU
结局指标
主要结局
acceptation rate of the entire sequence by eligible patients
时间窗: 13 weeks
acceptation rate of the entire sequence by eligible patients
次要结局
- radiological changes while on chimiotherapy, to tumour regression, and prognosis(13 weeks)