Positron Emission Tomography (PET) Interest in the Follow Up of Colorectal Cancer Stage II and III

Study Overview
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Brief Summary
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The follow up of colorectal cancer after curative surgery has to find loco-regional relapses or synchronous metastases, and to detect adenomas and new cancer on the rest of the colon. The increase of survival after relapse of the colorectal cancer depends on the possibility of curative action or after chemotherapy response. This is a Phase III open-labeled, multicenter, multidisciplinary, randomised study, comparing 2 arms of 188 patients (i.e. 376 total patients). Study Period (date of first inclusion/last inclusion): 3 years. Follow Up: 3 years. The primary objective is the evaluation of PET performance in the earlier relapse detection of the colorectal cancer relapse in comparison with conventional control (including carcinoembryonic [CEA] levels and other classic radiological exams).

Official Title
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PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: PET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated written informed consent Confirmed stage II or III (TNM) Patient with curative surgery for colorectal adenocarcinoma Total digestive endoscopy prior or post surgery. Age > 18 years old Normal liver ultrasound and chest X-ray or thoraco-abdomino pelvic computed tomography (CT) scan. In fertile women, efficient contraception or postmenopausal patient (amenorrhea for at least 1 year) Exclusion Criteria: Serious concomitant pathology Uncontrolled diabetes with a classical treatment (glycaemia >1.4 g/l) Other malignant tumour within the last 5 years (except for curatively treated basocellular carcinoma of the skin or in situ cervical carcinoma). Uncontrolled infection Women who are pregnant or lactating Inability to understand informed consent Psychological or geographic impossibility to follow up for three years.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PET|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to colorectal cancer relapse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of overall survival in the two groups |  | after curative resection of colorectal cancer stage II or III | 
| Evaluation of the rate of curative surgery |  | after relapse | 
| Comparison of the medical cost in the two detection strategies |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer stage II and III