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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01619696
Enrollment
3
Registered
2012-06-14
Start date
2011-03-31
Completion date
2012-12-31
Last updated
2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Adenocarcinoma

Keywords

chemotherapy, rectal adenocarcinoma, proctectomy, Fmiso TEP, MRI

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.

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.

Interventions

PROCEDUREPelvic MRI and F MISO TEP

Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.

Sponsors

Centre National de la Recherche Scientifique, France
CollaboratorOTHER
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
acceptation rate of the entire sequence by eligible patients13 weeksacceptation rate of the entire sequence by eligible patients

Secondary

MeasureTime frameDescription
radiological changes while on chimiotherapy, to tumour regression, and prognosis13 weeksradiological changes while on chimiotherapy, to tumour regression, and prognosis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026