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

NCT ID: NCT01619696

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Rectal Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Pelvic MRI and F MISO TEP

Intervention Type PROCEDURE

Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.

Interventions

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Pelvic MRI and F MISO TEP

Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Portier, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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CHU Toulouse

Toulouse, Toulouse, France

Site Status

Countries

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France

Other Identifiers

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0932103

Identifier Type: -

Identifier Source: org_study_id

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