Clinical trial NCT00199654: Positron Emission Tomography (PET) Interest in the Follow Up of Colorectal Cancer Stage II and III
Official title: PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: colorectal cancer stage II and III
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Time to colorectal cancer relapse
Secondary outcomes:
measure: Evaluation of overall survival in the two groups
timeFrame: after curative resection of colorectal cancer stage II or III
measure: Evaluation of the rate of curative surgery
timeFrame: after relapse
measure: Comparison of the medical cost in the two detection strategies
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Cancérologie et Hépato-Gastro-Entérologie
city: Caen
country: France
facility: Institut François Baclesse
city: Limoges
country: France
facility: Médecine Nucléaire
city: Limoges
country: France
facility: Oncologie Médicale
city: Marseille
country: France
facility: Oncologie Digestive
Study officials:
affiliation: University Hospital, Limoges
name: Nicole TUBIANA-MATHIEU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monteil J, Le Brun-Ly V, Cachin F, Zasadny X, Seitz JF, Mundler O, Selvy M, Smith D, Rullier E, Lavau-Denes S, Lades G, Labrunie A, Lecaille C, Valli N, Leobon S, Terrebonne E, Deluche E, Tubiana-Mathieu N. Comparison of 18FDG-PET/CT and conventional follow-up methods in colorectal cancer: A randomised prospective study. Dig Liver Dis. 2021 Feb;53(2):231-237. doi: 10.1016/j.dld.2020.10.012. Epub 2020 Nov 2.