Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer
This study is currently recruiting participants.
Verified August 2009 by National Cancer Institute (NCI)
Sponsor:
University Hospital Southampton NHS Foundation Trust.
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00560365
First received: November 16, 2007
Last updated: August 5, 2011
Last verified: August 2009
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Purpose
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 | Intervention |
|---|---|
|
Colorectal Cancer |
Other: laboratory biomarker analysis Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: quality-of-life assessment |
| Study Type: | Observational |
| 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) |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival by intention-to-treat analysis [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of life [ Designated as safety issue: No ]
- Cost of National Health Service (NHS) services utilized [ Designated as safety issue: No ]
- NHS cost per life-year saved [ Designated as safety issue: No ]
| Estimated Enrollment: | 4760 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of primary colorectal cancer
- Stage I-III disease
Have undergone curative resection (i.e., no residual disease [R0])
- Microscopically clear margins
- Complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, CT pneumocolon, or virtual colonoscopy
Post-operative blood CEA ≤ 10 ng/mL (if the normal range is ≤ 5 ng/mL) OR < 2 times upper limit of normal (if normal range is > 5 ng/mL)
- For patients undergoing adjuvant therapy, CEA should be measured after completion of chemotherapy
Has completed primary curative treatment, as deemed by hospital clinician
- Patients awaiting stoma closure allowed
- No evidence of metastatic disease on pre- or post-operative liver CT scan (or ultrasound) and chest CT scan (or chest x-ray)
- No diagnosis of familial adenomatous polyposis (FAP) or dominantly inherited colon cancer
PATIENT CHARACTERISTICS:
- No concurrent serious illness
- History of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved
- No concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560365
Locations
| United Kingdom | |
| Queen's Hospital | Recruiting |
| Burton-upon-Trent, England, United Kingdom, DE13 0RB | |
| Contact: Contact Person 44-1283-566-333 | |
| Cumberland Infirmary | Recruiting |
| 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 | |
| Hinchingbrooke Hospital | Recruiting |
| 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 | |
| Derriford Hospital | Recruiting |
| 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 Hospital | Recruiting |
| 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 | |
| Hillingdon Hospital | Recruiting |
| 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 | |
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust.
Investigators
| Study Chair: | John N. Primrose, MD | University Hospital Southampton NHS Foundation Trust. |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00560365 History of Changes |
| Other Study ID Numbers: | CDR0000576476, USCTU-FACS, ISRCTN41458548, EU-20788 |
| Study First Received: | November 16, 2007 |
| Last Updated: | August 5, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage I colon cancer stage II colon cancer stage III colon cancer |
stage I rectal cancer stage II rectal cancer stage III rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013