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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01619696
Other study ID # 0932103
Secondary ID
Status Terminated
Phase Phase 2
First received June 12, 2012
Last updated January 22, 2013
Start date March 2011
Est. completion date December 2012

Study information

Verified date January 2013
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


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.

Locations

Country Name City State
France CHU Toulouse Toulouse

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Toulouse France: Centre National de la Recherche Scientifique, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary acceptation rate of the entire sequence by eligible patients acceptation rate of the entire sequence by eligible patients 13 weeks Yes
Secondary radiological changes while on chimiotherapy, to tumour regression, and prognosis radiological changes while on chimiotherapy, to tumour regression, and prognosis 13 weeks Yes
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