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Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
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
  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)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014