Trial Information

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.