Last updated on August 2011

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


Brief description of study

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 Study Description

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.

Clinical Study Identifier: NCT00560365

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Mayday University Hospital
Croydon, United Kingdom
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Charing Cross Hospital
London, United Kingdom
9.28miles
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