Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): Standard Monitoring CEA; Intensive Monitoring CEA; Standard Monitoring Imagery; Intensive Monitoring Imagery
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): No specific follow-up of CEA; CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.; Abdominal ultrasound examination every 3 months during 3 years then every 6 months during 2 years then annually. Chest X-ray examination eveyr 6 months during 3 years then annually during 2 years; Alternation every 3 months of TDM thoraco-abdomino-pelvis and abdominal ultrasound examination during 3 years and twice a year after during 2 years. Coloscopy at 3 years and then evry 5 years if normal
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: This study is a surveillance study not an interventional study with products
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: stage II colon cancer; stage II rectal cancer; stage III colon cancer; stage III rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum