NCT00560365

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

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,760 (estimated)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis
PROCEDURE	computed tomography
PROCEDURE	magnetic resonance imaging
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2004-03-01
• Primary completion: 2013-12-01
• First posted: 2007-11-19
• Last updated: 2011-08-08

Locations

31 sites across 1 country: United Kingdom