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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Rectal Adenocarcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

acceptation rate of the entire sequence by eligible patients

Outcome Description:

acceptation rate of the entire sequence by eligible patients

Outcome Time Frame:

13 weeks

Safety Issue:

Yes

Principal Investigator

Guillaume Portier, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Toulouse

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

0932103

NCT ID:

NCT01619696

Start Date:

March 2011

Completion Date:

December 2012

Related Keywords:

  • Rectal Adenocarcinoma
  • chemotherapy
  • rectal adenocarcinoma
  • proctectomy
  • Fmiso TEP
  • MRI
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms

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