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

Primary Purpose

Rectal Adenocarcinoma

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Pelvic MRI and F MISO TEP
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Adenocarcinoma focused on measuring chemotherapy, rectal adenocarcinoma, proctectomy, Fmiso TEP, MRI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

acceptation rate of the entire sequence by eligible patients
acceptation rate of the entire sequence by eligible patients

Secondary Outcome Measures

radiological changes while on chimiotherapy, to tumour regression, and prognosis
radiological changes while on chimiotherapy, to tumour regression, and prognosis

Full Information

First Posted
June 12, 2012
Last Updated
January 22, 2013
Sponsor
University Hospital, Toulouse
Collaborators
Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01619696
Brief Title
Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas
Official Title
Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Adenocarcinoma
Keywords
chemotherapy, rectal adenocarcinoma, proctectomy, Fmiso TEP, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Pelvic MRI and F MISO TEP
Intervention Description
Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.
Primary Outcome Measure Information:
Title
acceptation rate of the entire sequence by eligible patients
Description
acceptation rate of the entire sequence by eligible patients
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
radiological changes while on chimiotherapy, to tumour regression, and prognosis
Description
radiological changes while on chimiotherapy, to tumour regression, and prognosis
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Portier, PhD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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