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

Phase 3

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00199654
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Primary Completion: 2012-11
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-08
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to colorectal cancer relapse

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Oncologie Digestive; 🇫🇷 Marseille, France

Cancérologie et Hépato-Gastro-Entérologie; 🇫🇷 Bordeaux, France

Institut François Baclesse; 🇫🇷 Caen, France

Médecine Nucléaire; 🇫🇷 Limoges, France

Oncologie Médicale; 🇫🇷 Limoges, France