Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Burton-upon-Trent, England, United Kingdom, DE13 0RB|
|Contact: Contact Person 44-1283-566-333|
|Carlisle, England, United Kingdom, CA2 7HY|
|Contact: Contact Person 44-1228-523-444|
|Saint Richards Hospital||Recruiting|
|Chichester, England, United Kingdom, P019 4SE|
|Contact: Contact Person 44-1243-788-122|
|Queen Alexandra Hospital||Recruiting|
|Cosham, England, United Kingdom, PO6 3LY|
|Contact: Contact Person 44-23-9228-6710|
|Castle Hill Hospital||Recruiting|
|Cottingham, England, United Kingdom, HU16 5JQ|
|Contact: Contact Person 44-1482-659-331|
|Mid Cheshire Hospitals Trust- Leighton Hopsital||Recruiting|
|Crewe, England, United Kingdom, CW1 4QJ|
|Contact: Contact Person 44-1270-255-141|
|Mayday University Hospital||Recruiting|
|Croydon, England, United Kingdom|
|Contact: Contact Person 44-20-8401-3000|
|Darent Valley Hospital||Recruiting|
|Dartford Kent, England, United Kingdom, DA2 8DA|
|Contact: Contact Person 44-1322-428-500|
|Royal Derby Hospital||Recruiting|
|Derby, England, United Kingdom, DE22 3NE|
|Contact: Contact Person 44-1332-340-131|
|Russells Hall Hospital||Recruiting|
|Dudley, England, United Kingdom, DY1 2HQ|
|Contact: Contact Person 44-1384-456-111|
|Grantham and District Hospital||Recruiting|
|Grantham, Lincolnshire, England, United Kingdom, NG31 8DG|
|Contact: Contact Person 44-1476-565-232|
|Harrogate District Hospital||Recruiting|
|Harrogate, England, United Kingdom, HG2 7SX|
|Contact: Contact Person 44-1423-885-959|
|St. Mark's Hospital||Recruiting|
|Harrow, England, United Kingdom, HA1 3UJ|
|Contact: Contact Person 44-20-8235-4000|
|Wycombe General Hospital||Recruiting|
|High Wycombe, England, United Kingdom|
|Contact: Contact Person 44-1494-426-234|
|Huntingdon, England, United Kingdom, PE18 6NT|
|Contact: Contact Person 44-1480-416-416|
|West Middlesex University Hospital||Recruiting|
|Isleworth, England, United Kingdom, TW7 6AF|
|Contact: Contact Person 44-20-8560-2121|
|Leeds General Infirmary||Recruiting|
|Leeds, England, United Kingdom, LS1 3EX|
|Contact: Contact Person 44-113-243-2799|
|Charing Cross Hospital||Recruiting|
|London, England, United Kingdom, W6 8RF|
|Contact: Contact Person 44-20-8846-1234|
|Mid Kent Oncology Centre at Maidstone Hospital||Recruiting|
|Maidstone, England, United Kingdom, ME16 9QQ|
|Contact: Contact Person 44-1622-729-000|
|Queen's Medical Centre||Recruiting|
|Nottingham, England, United Kingdom, NG7 2UH|
|Contact: Contact Person 44-115-924-9924|
|Plymouth, England, United Kingdom, PL6 8DH|
|Contact: Contact Person 44-175-277-7111|
|Scarborough General Hospital||Recruiting|
|Scarborough, England, United Kingdom, YO12 6QL|
|Contact: Contact Person 44-1723-342-175|
|Royal Shrewsbury Hospital||Recruiting|
|Shrewsbury, England, United Kingdom, SY3 8XQ|
|Contact: Contact Person 44-1743-261-000|
|Wexham Park Hospital||Recruiting|
|Slough, Berkshire, England, United Kingdom, SL2 4HL|
|Contact: Contact Person 44-1753-634-191|
|Solihull, England, United Kingdom, B91 2JL|
|Contact: Contact Person 44-121-424-2000|
|Southampton General Hospital||Recruiting|
|Southampton, England, United Kingdom, SO16 6YD|
|Contact: Contact Person 44-23-8079-8751|
|St. Peter's Hospital||Recruiting|
|Surrey, England, United Kingdom, KT 16 OPZ|
|Contact: Contact Person 44-1932-722-233|
|Royal Cornwall Hospital||Recruiting|
|Truro, Cornwall, England, United Kingdom, TR1 3LJ|
|Contact: Contact Person 44-1872-250-000|
|Uxbridge, England, United Kingdom, UB8 3NN|
|Contact: Contact Person 44-1895-238-282|
|Warrington Hospital NHS Trust||Recruiting|
|Warrington, England, United Kingdom, WA5 1QG|
|Contact: Contact Person 44-1925-635-911|
|Worcester Royal Hospital||Recruiting|
|Worcester, England, United Kingdom, WR5 1DD|
|Contact: Contact Person 44-1905-760-719|
|Study Chair:||John N. Primrose, MD||University Hospital Southampton NHS Foundation Trust|