Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00560365
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4760
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival by intention-to-treat analysis
- Secondary Outcome Measures
Name Time Method Quality of life Cost of National Health Service (NHS) services utilized NHS cost per life-year saved
Trial Locations
- Locations (31)
Grantham and District Hospital
🇬🇧Grantham, Lincolnshire, England, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, England, United Kingdom
Queen's Hospital
🇬🇧Burton-upon-Trent, England, United Kingdom
Queen Alexandra Hospital
🇬🇧Cosham, England, United Kingdom
Hinchingbrooke Hospital
🇬🇧Huntingdon, England, United Kingdom
West Middlesex University Hospital
🇬🇧Isleworth, England, United Kingdom
St. Mark's Hospital
🇬🇧Harrow, England, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Hillingdon Hospital
🇬🇧Uxbridge, England, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, England, United Kingdom
Warrington Hospital NHS Trust
🇬🇧Warrington, England, United Kingdom
Darent Valley Hospital
🇬🇧Dartford Kent, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Scarborough General Hospital
🇬🇧Scarborough, England, United Kingdom
Saint Richards Hospital
🇬🇧Chichester, England, United Kingdom
Mid Cheshire Hospitals Trust- Leighton Hopsital
🇬🇧Crewe, England, United Kingdom
Mayday University Hospital
🇬🇧Croydon, England, United Kingdom
Royal Derby Hospital
🇬🇧Derby, England, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, England, United Kingdom
Harrogate District Hospital
🇬🇧Harrogate, England, United Kingdom
Wycombe General Hospital
🇬🇧High Wycombe, England, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
Solihull Hospital
🇬🇧Solihull, England, United Kingdom
St. Peter's Hospital
🇬🇧Surrey, England, United Kingdom
Worcester Royal Hospital
🇬🇧Worcester, England, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, England, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom