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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Standard Monitoring CEA
* Procedure: Intensive Monitoring CEA
* Procedure: Standard Monitoring Imagery
* Procedure: Intensive Monitoring Imagery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Pathologically confirmed adenocarcinoma of the colon or rectum Stage II or III disease No distant metastatic disease Has undergone curative resection for no residual tumor Carcinoembryonic antigen (CEA) ≤ 1.5 x upper limit of normal after surgery PATIENT CHARACTERISTICS: WHO performance status 0-1 Not pregnant or nursing Fertile patients must use effective contraception No inflammatory bowel disease No other malignancy within the past 5 years except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix No genetic syndromes PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This study is a surveillance study not an interventional study with products
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Monitoring CEA/ Standard Imagery<br>No specific follow-up of CEA and Standard imagery | Procedure: Standard Monitoring CEA<br>* No specific follow-up of CEA<br>Procedure: Standard Monitoring Imagery<br>* 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<br>|
| Other: Intensive monitoring CEA/ Standard Imagery<br>Intensive follow-up CEA and Standard imagery . | Procedure: Intensive Monitoring CEA<br>* CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.<br>Procedure: Standard Monitoring Imagery<br>* 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<br>|
| Other: Intensive Monitoring CEA / Intensive Monitoring Imagery<br>Intensive follow-up CEA and Intensive imagery | Procedure: Intensive Monitoring CEA<br>* CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.<br>Procedure: Intensive Monitoring Imagery<br>* 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<br>|
| Other: Standard Monitoring CEA/ Intensive Monitoring Imagery<br>No specific follow-up of CEA and Intensive Imagery | Procedure: Standard Monitoring CEA<br>* No specific follow-up of CEA<br>Procedure: Intensive Monitoring Imagery<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate | Time between randomization and date of death (all causes) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival rate | Time between randomization and first recurrence (local or metastatic) or death (all causes) | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III rectal cancer, stage II colon cancer, stage II rectal cancer, stage III colon cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum