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Sponsored by: |
Southampton General Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00560365 |
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 |
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Colorectal Cancer |
Procedure: computed tomography Procedure: laboratory biomarker analysis Procedure: magnetic resonance imaging Procedure: observation Procedure: quality-of-life assessment |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Active Control |
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) |
Estimated Enrollment: | 4760 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of primary colorectal cancer
Have undergone curative resection (i.e., no residual disease [R0])
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)
Has completed primary curative treatment, as deemed by hospital clinician
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Castle Hill Hospital | Recruiting |
Cottingham, England, United Kingdom, HU16 5JQ | |
Contact: Contact Person 44-1482-659-331 | |
Charing Cross Hospital | Recruiting |
London, England, United Kingdom, W6 8RF | |
Contact: Contact Person 44-20-8846-1234 | |
Cumberland Infirmary | Recruiting |
Carlisle, England, United Kingdom, CA2 7HY | |
Contact: Contact Person 44-1228-523-444 | |
Darent Valley Hospital | Recruiting |
Dartford Kent, England, United Kingdom, DA2 8DA | |
Contact: Contact Person 44-1322-428-500 | |
Derby City General Hospital | Recruiting |
Derby, England, United Kingdom, DE22 3NE | |
Contact: Contact Person 44-1332-340-131 | |
Derriford Hospital | Recruiting |
Plymouth, England, United Kingdom, PL6 8DH | |
Contact: Contact Person 44-175-277-7111 | |
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 | |
Hillingdon Hospital | Recruiting |
Uxbridge, England, United Kingdom, UB8 3NN | |
Contact: Contact Person 44-1895-238-282 | |
Hinchingbrooke Hospital | Recruiting |
Huntingdon, England, United Kingdom, PE18 6NT | |
Contact: Contact Person 44-1480-416-416 | |
Leeds General Infirmary | Recruiting |
Leeds, England, United Kingdom, LS1 3EX | |
Contact: Contact Person 44-113-243-2799 | |
Mayday University Hospital | Recruiting |
Croydon, England, United Kingdom | |
Contact: Contact Person 44-20-8401-3000 | |
Mid Cheshire Hospitals Trust- Leighton Hopsital | Recruiting |
Crewe, England, United Kingdom, CW1 4QJ | |
Contact: Contact Person 44-1270-255-141 | |
Mid Kent Oncology Centre at Maidstone Hospital | Recruiting |
Maidstone, England, United Kingdom, ME16 9QQ | |
Contact: Contact Person 44-1622-729-000 | |
Queen Alexandra Hospital | Recruiting |
Cosham, England, United Kingdom, PO6 3LY | |
Contact: Contact Person 44-23-9228-6710 | |
Wycombe General Hospital | Recruiting |
High Wycombe, England, United Kingdom | |
Contact: Contact Person 44-1494-426-234 | |
Queen's Medical Centre | Recruiting |
Nottingham, England, United Kingdom, NG7 2UH | |
Contact: Contact Person 44-115-924-9924 | |
Royal Cornwall Hospital | Recruiting |
Truro, Cornwall, England, United Kingdom, TR1 3LJ | |
Contact: Contact Person 44-1872-250-000 | |
Royal Shrewsbury Hospital | Recruiting |
Shrewsbury, England, United Kingdom, SY3 8XQ | |
Contact: Contact Person 44-1743-261-000 | |
Russells Hall Hospital | Recruiting |
Dudley, England, United Kingdom, DY1 2HQ | |
Contact: Contact Person 44-1384-456-111 | |
Saint Richards Hospital | Recruiting |
Chichester, England, United Kingdom, P019 4SE | |
Contact: Contact Person 44-1243-788-122 | |
Scarborough General Hospital | Recruiting |
Scarborough, England, United Kingdom, YO12 6QL | |
Contact: Contact Person 44-1723-342-175 | |
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. Mark's Hospital | Recruiting |
Harrow, England, United Kingdom, HA1 3UJ | |
Contact: Contact Person 44-20-8235-4000 | |
St. Peter's Hospital | Recruiting |
Surrey, England, United Kingdom, KT 16 OPZ | |
Contact: Contact Person 44-1932-722-233 | |
Warrington Hospital NHS Trust | Recruiting |
Warrington, England, United Kingdom, WA5 1QG | |
Contact: Contact Person 44-1925-635-911 | |
West Middlesex University Hospital | Recruiting |
Isleworth, England, United Kingdom, TW7 6AF | |
Contact: Contact Person 44-20-8560-2121 | |
Wexham Park Hospital | Recruiting |
Slough, Berkshire, England, United Kingdom, SL2 4HL | |
Contact: Contact Person 44-1753-634-191 | |
Worcester Royal Hospital | Recruiting |
Worcester, England, United Kingdom, WR5 1DD | |
Contact: Contact Person 44-1905-760-719 | |
Queen's Hospital | Recruiting |
Burton-upon-Trent, England, United Kingdom, DE13 0RB | |
Contact: Contact Person 44-1283-566-333 |
Study Chair: | John N. Primrose, MD | Southampton General Hospital |
Study ID Numbers: | CDR0000576476, USCTU-FACS, ISRCTN41458548, EU-20788 |
Study First Received: | November 16, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00560365 |
Health Authority: | Unspecified |
stage I colon cancer stage II colon cancer stage III colon cancer |
stage I rectal cancer stage II rectal cancer stage III rectal cancer |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal cancer Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms Rectal neoplasm |
Neoplasms Neoplasms by Site |