Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer

Overview

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.

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.