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

Rectal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01619696
• Other study ID #: 0932103
• 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

• Adenocarcinoma
• Rectal Adenocarcinoma
• Rectal Neoplasms

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