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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199654

Enrollment

376

Registered

2005-09-20

Start date

2004-02-29

Completion date

2013-04-30

Last updated

2013-04-09

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

Conditions

Colorectal Cancer

Keywords

colorectal cancer stage II and III

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).

Interventions

PROCEDUREPET

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Time to colorectal cancer relapse	—

Secondary

Measure	Time frame
Comparison of the medical cost in the two detection strategies	—
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

Countries

France

Outcome results

None listed

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