Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer
Recruitment status was Recruiting
RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.
PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.
Other: diagnostic laboratory biomarker analysis
Procedure: computed tomography
Procedure: diagnostic colonoscopy
Procedure: standard follow-up care
Procedure: ultrasound imaging
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study|
- Increase of 5% of the 5-year overall survival rate [ Designated as safety issue: No ]
- Disease-free survival rate [ Designated as safety issue: No ]
- Curative resection rate in case of recurrence [ Designated as safety issue: No ]
- 5-year overall survival rate [ Designated as safety issue: No ]
- Cost-effectiveness study [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
- Evaluate the efficacy of reinforced versus standard follow-up care and the utility of follow-up CEA assessments in patients with fully resected stage II or III colorectal cancer.
OUTLINE: This is a multinational/multicenter study. Patients are randomized to 1 of 2 follow-up arms.
- Standard follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo abdominal ultrasound every 3 months until year 3 and then every 6 months until year 5; chest x-ray every 6 months until year 3 and then annually until year 5; and colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.
- Reinforced follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo alternate assessments every 3 months comprising thoraco-abdomino-pelvic CT scan or abdominal ultrasound until year 3 and then every 6 months until year 5. They also undergo colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.
Patients undergo a second randomization to 1 of 2 follow-up arms at the beginning of the study.
- CEA measurement: Patients undergo measurement of CEA levels every 3 months until year 3, every 6 months until year 5, and at least yearly thereafter.
- No CEA measurement: Patients do not undergo CEA measurement. Blood and tissue blocks of normal and tumor tissues are collected for the validation of protein serum, genetics, or immunologic markers predictive for relapse.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995202
|Federation Francophone de Cancerologie Digestive||Recruiting|
|Dijon, France, 21079|
|Contact: Come Lepage, MD 33-380-393-340|
|Principal Investigator:||Come Lepage, MD||Centre Hospitalier Universitaire de Dijon|