Status:
COMPLETED
Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the three years following the tumoral resection with curative aim. Therefore, a prolonged follow-up and an intense...
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- 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- 2 before criteria have been replaced by : Patients with colorectal adenocarcinoma which is histologically proved and classified stage II perforated, III or IV, totally removed, in total remission,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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00624260
Start Date
June 1 2008
End Date
June 1 2015
Last Update
March 18 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Henri Mondor
Créteil, France, 94000