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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199654
• Other study ID #: I03001
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: April 8, 2013
• Start date: February 2004
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: April 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• PET

Locations

Country	Name	City	State
France	Cancérologie et Hépato-Gastro-Entérologie	Bordeaux
France	Institut François Baclesse	Caen
France	Médecine Nucléaire	Limoges
France	Oncologie Médicale	Limoges
France	Oncologie Digestive	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to colorectal cancer relapse			No
Secondary	Evaluation of overall survival in the two groups		after curative resection of colorectal cancer stage II or III	No
Secondary	Evaluation of the rate of curative surgery		after relapse	No
Secondary	Comparison of the medical cost in the two detection strategies			No