Positron Emission Tomography (PET) Interest in the Follow Up of Colorectal Cancer Stage II and III
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|ClinicalTrials.gov Identifier: NCT00199654|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 9, 2013
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).
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: PET||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||376 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||April 2013|
- Time to colorectal cancer relapse
- Evaluation of overall survival in the two groups [ Time Frame: after curative resection of colorectal cancer stage II or III ]
- Evaluation of the rate of curative surgery [ Time Frame: after relapse ]
- Comparison of the medical cost in the two detection strategies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199654
|Cancérologie et Hépato-Gastro-Entérologie|
|Bordeaux, France, 33000|
|Institut François Baclesse|
|Caen, France, 14000|
|Limoges, France, 87000|
|Limoges, France, 87000|
|Marseille, France, 13000|
|Principal Investigator:||Nicole TUBIANA-MATHIEU, MD||University Hospital, Limoges|