Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
OBJECTIVES:
- 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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Diagnostic
Increase of 5% of the 5-year overall survival rate
No
Come Lepage, MD
Principal Investigator
Centre Hospitalier Universitaire de Dijon
Unspecified
CDR0000654114
NCT00995202
September 2009
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