Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer

Study Overview
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Brief Summary
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RATIONALE: Following patients who have undergone surgery for colorectal cancer may help doctors learn more about the disease and plan better follow-up care. PURPOSE: This randomized clinical trial is following patients who have undergone surgery for stage I, stage II, or stage III colorectal cancer.

Detailed Description
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OBJECTIVES: Primary To assess the effect of augmenting symptomatic follow-up in primary care with two intensive methods of follow-up (monitoring tumor marker in primary care and intensive imaging in hospital) on survival of patients with stage I, II, or III colorectal cancer who have undergone curative resection. Secondary Determine the quality of life of these patients. Determine the cost of National Health Service (NHS) services utilized. Determine the NHS cost per life-year saved. OUTLINE: This is a multicenter study. Patients are stratified according to certainty of need for imaging follow-up, as determined by the local clinician (uncertain vs certain). Patients are randomized to 1 of 4 follow-up arms. Arm I (primary care follow-up): Patients undergo symptomatic follow-up (i.e., are asked to contact their physician if they have symptoms suggestive of disease recurrence). Some patients may also undergo a single CT scan 12-18 months post-randomization. Arm II (primary care follow-up): Patients undergo tumor marker measurements (CEA) at baseline, every 3 months for 2 years, and every 6 months for 3 years. Some patients may also undergo a single CT scan 12-18 months post-randomization. Arm III (intensive hospital follow-up): Patients undergo CT scan or MRI at baseline, every 6 months for 2 years, and then annually for 3 years. Arm IV (primary care and intensive hospital follow-up): Patients undergo primary care and intensive hospital follow-up as in arms II (without the single CT scan) and III. All patients receive a handbook from their physician detailing possible symptoms suggestive of disease recurrence. Quality of life is assessed at baseline and then annually for 5 years.

Official Title
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A Randomised Controlled Trial to Assess the Cost-effectiveness of Intensive Versus no Scheduled Follow-up in Patients Who Have Undergone Resection for Colorectal Cancer With Curative Intent. (FACS - Follow-up After Colorectal Surgery)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Procedure: computed tomography
* Procedure: magnetic resonance imaging
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of primary colorectal cancer Stage I-III disease Have undergone curative resection (i.e., no residual disease [R0]) Microscopically clear margins Complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, CT pneumocolon, or virtual colonoscopy Post-operative blood CEA ≤ 10 ng/mL (if the normal range is ≤ 5 ng/mL) OR < 2 times upper limit of normal (if normal range is > 5 ng/mL) For patients undergoing adjuvant therapy, CEA should be measured after completion of chemotherapy Has completed primary curative treatment, as deemed by hospital clinician Patients awaiting stoma closure allowed No evidence of metastatic disease on pre- or post-operative liver CT scan (or ultrasound) and chest CT scan (or chest x-ray) No diagnosis of familial adenomatous polyposis (FAP) or dominantly inherited colon cancer PATIENT CHARACTERISTICS: No concurrent serious illness History of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up PRIOR CONCURRENT THERAPY: See Disease Characteristics Pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved No concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements

Ages Eligible for Study
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Minimum Age: 50 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|
|Procedure: computed tomography|nan|
|Procedure: magnetic resonance imaging|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival by intention-to-treat analysis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Cost of National Health Service (NHS) services utilized |  |  | 
| NHS cost per life-year saved |  |  | 

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