Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00560365|
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : November 19, 2007
Last Update Posted : August 8, 2011
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.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Other: laboratory biomarker analysis Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: quality-of-life assessment|
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||4760 participants|
|Official Title:||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)|
|Study Start Date :||March 2004|
|Estimated Primary Completion Date :||December 2013|
- Overall survival by intention-to-treat analysis
- Quality of life
- Cost of National Health Service (NHS) services utilized
- NHS cost per life-year saved
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560365
|Study Chair:||John N. Primrose, MD||University Hospital Southampton NHS Foundation Trust|