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

Colorectal Cancer Clinical Trial

Official title: Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT00995202
• Study type: Interventional
• Source: Federation Francophone de Cancerologie Digestive
• Status: Completed
• Phase: Phase 3
• Start date: September 2009
• Completion date: June 2021