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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. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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
Burton-upon-Trent, England, United Kingdom, DE13 0RB
Cumberland Infirmary
Carlisle, England, United Kingdom, CA2 7HY
Saint Richards Hospital
Chichester, England, United Kingdom, P019 4SE
Queen Alexandra Hospital
Cosham, England, United Kingdom, PO6 3LY
Castle Hill Hospital
Cottingham, England, United Kingdom, HU16 5JQ
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, United Kingdom, CW1 4QJ
Mayday University Hospital
Croydon, England, United Kingdom
Darent Valley Hospital
Dartford Kent, England, United Kingdom, DA2 8DA
Royal Derby Hospital
Derby, England, United Kingdom, DE22 3NE
Russells Hall Hospital
Dudley, England, United Kingdom, DY1 2HQ
Grantham and District Hospital
Grantham, Lincolnshire, England, United Kingdom, NG31 8DG
Harrogate District Hospital
Harrogate, England, United Kingdom, HG2 7SX
St. Mark's Hospital
Harrow, England, United Kingdom, HA1 3UJ
Wycombe General Hospital
High Wycombe, England, United Kingdom
Hinchingbrooke Hospital
Huntingdon, England, United Kingdom, PE18 6NT
West Middlesex University Hospital
Isleworth, England, United Kingdom, TW7 6AF
Leeds General Infirmary
Leeds, England, United Kingdom, LS1 3EX
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Scarborough General Hospital
Scarborough, England, United Kingdom, YO12 6QL
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom, SY3 8XQ
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom, SL2 4HL
Solihull Hospital
Solihull, England, United Kingdom, B91 2JL
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
St. Peter's Hospital
Surrey, England, United Kingdom, KT 16 OPZ
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Hillingdon Hospital
Uxbridge, England, United Kingdom, UB8 3NN
Warrington Hospital NHS Trust
Warrington, England, United Kingdom, WA5 1QG
Worcester Royal Hospital
Worcester, England, United Kingdom, WR5 1DD
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Investigators
Study Chair: John N. Primrose, MD University Hospital Southampton NHS Foundation Trust
  More Information

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 December 02, 2016