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.

Inclusion criteria

• Patients with a removed colorectal adenocarcinoma since less than 6 months, in total remission and for whom a monitoring is necessary to detect recurrences precociously.
• Patients with a removed colorectal tumour which is histologically proved and classified N+ and/or M+ (stage III or IV). Hepatic and/or pulmonary metastasis would have been totally removed since less 6 months before inclusion.
• Patients with a T4N0M0 tumour and operated in emergency (because of a tumoral perforation) can be included. (suppressed by amendment 1)
• 2 before criteria have been replaced by : Patients with colorectal adenocarcinoma which is histologically proved and classified stage II perforated, III or IV, totally removed, in total remission,
• if no metastatic, removed surgery must have been done since less 6 months;
• if metastatic, all metastasis would have been removed, the last surgery dating less 6 months.(amendment 1)
• Casual extension check-up would have been realized before initial surgery or during a period of 6 months after surgery performed in emergency.
• informed consent signed
• Age ≥ 18 years
• Patient in ability to undergone hepatic or pulmonary resection in case of recurrence during the follow-up (ECOG ≤ 2)
• Willingness to control visits

Exclusion criteria

• pregnant or breast feeding women, or with a reproductive potential and no practicing an effective method of contraception during the second part of ovarian cycle ( PET is realised during the first part of ovarian cycle)
• Cancer stage I or II (except T4 operated in emergency) or IV without possibility to remove metastasis or R2 after surgery.
• Performance status contraindicating a hepatic or pulmonary surgery in case of recurrence.
• Patients likely to undergone chemotherapy, surgery or radiotherapy during 2 weeks before PET-TDM.
• Other progressive tumoral affection known, or colorectal cancer in progression.

• (Bad compliance to the study procedure.)(suppressed by amendment 1)
• Not balanced diabetes. (added by amendment 1)
• Patients included in others clinical trials of imagery.
• Inability to provide informed consent signed.
• No social assurance.