Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas

Phase 2

Terminated

• Conditions: Rectal Adenocarcinoma
• Interventions: Procedure: Pelvic MRI and F MISO TEP

• Registration Number: NCT01619696
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-14
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Pelvic MRI and F MISO TEP	-

Primary Outcome Measures

Name	Time	Method
acceptation rate of the entire sequence by eligible patients	13 weeks	acceptation rate of the entire sequence by eligible patients

Secondary Outcome Measures

Name	Time	Method
radiological changes while on chimiotherapy, to tumour regression, and prognosis	13 weeks	radiological changes while on chimiotherapy, to tumour regression, and prognosis

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France