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

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Collaborators:
France: Centre National de la Recherche Scientifique
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01619696
First received: June 12, 2012
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Rectal Adenocarcinoma
Procedure: Pelvic MRI and F MISO TEP
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • acceptation rate of the entire sequence by eligible patients [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
    acceptation rate of the entire sequence by eligible patients


Secondary Outcome Measures:
  • radiological changes while on chimiotherapy, to tumour regression, and prognosis [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
    radiological changes while on chimiotherapy, to tumour regression, and prognosis


Enrollment: 3
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619696

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

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01619696     History of Changes
Other Study ID Numbers: 0932103
Study First Received: June 12, 2012
Last Updated: January 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on October 29, 2014