Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rectal Adenocarcinoma
- Sponsor
- University Hospital, Toulouse
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- acceptation rate of the entire sequence by eligible patients
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •locally advanced (≥T3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge.
Exclusion Criteria
- •synchonous metastatis
- •previous malignant tumour
- •previous radiotherapy/ chemotherapy
- •performance status WHO\>2
- •contraindication to 5 FU
Outcomes
Primary Outcomes
acceptation rate of the entire sequence by eligible patients
Time Frame: 13 weeks
acceptation rate of the entire sequence by eligible patients
Secondary Outcomes
- radiological changes while on chimiotherapy, to tumour regression, and prognosis(13 weeks)