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

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ClinicalTrials.gov Identifier: NCT01619696
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : June 14, 2012
Last Update Posted : January 23, 2013
Sponsor:
Collaborators:
Centre National de la Recherche Scientifique, France
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rectal Adenocarcinoma Procedure: Pelvic MRI and F MISO TEP Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.
Study Start Date : March 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Intervention Procedure: 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.




Primary Outcome Measures :
  1. acceptation rate of the entire sequence by eligible patients [ Time Frame: 13 weeks ]
    acceptation rate of the entire sequence by eligible patients


Secondary Outcome Measures :
  1. radiological changes while on chimiotherapy, to tumour regression, and prognosis [ Time Frame: 13 weeks ]
    radiological changes while on chimiotherapy, to tumour regression, and prognosis



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619696


Locations
France
CHU Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Centre National de la Recherche Scientifique, France
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Guillaume Portier, PhD CHU Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01619696     History of Changes
Other Study ID Numbers: 0932103
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by University Hospital, Toulouse:
chemotherapy
rectal adenocarcinoma
proctectomy
Fmiso TEP
MRI

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases