Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study
Patients will be randomized in two groups: one (PET-TDM group) including a semi-annual
systematic PET-TDM during usual follow-up (M6, M12, M18, M24, M30 and M36 after initial
surgery) and the second (control group) in which one PET-TDM will be realized only for
current indication (high isolated markers or before a metastasis curative resection) during
usual follow-up. Will be included patients with a high risk of recurrence of a colorectal
tumor N+ or M+ completely removed (R0 or R1) or tumor stage 4, no regional lymph node
metastasis, no distant metastasis (T4N0M0) operated in emergency (tumoral perforation).
Patients will be followed-up during 3 years since the date of initial surgery. Conventional
follow-up will be performed by consensual recommendations for all the patients. In the case
of detecting a recurrence, the adapted treatment (surgery or chemotherapy or both) with
curative aim will be implemented and the follow-up will be carried out in its term or death.
In the case of non curable recurrence, the follow-up will be carried out in its term or
death, and the PET-TDM will not be realised any more.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Percentage of patients with a non removable recurrence
at the end of the study
Iradj Sobhani, MD, PhD
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health