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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: computed tomography; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Procedure: magnetic resonance imaging

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.

• Study Type: Observational
• Enrollment (Anticipated): 4760

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Burton-upon-Trent, England, United Kingdom, DE13 0RB
      • Recruiting
      • Queen's Hospital
      • Contact: Contact Person; Phone Number: 44-1283-566-333
    • Carlisle, England, United Kingdom, CA2 7HY
      • Recruiting
      • Cumberland Infirmary
      • Contact: Contact Person; Phone Number: 44-1228-523-444
    • Chichester, England, United Kingdom, P019 4SE
      • Recruiting
      • Saint Richards Hospital
      • Contact: Contact Person; Phone Number: 44-1243-788-122
    • Cosham, England, United Kingdom, PO6 3LY
      • Recruiting
      • Queen Alexandra Hospital
      • Contact: Contact Person; Phone Number: 44-23-9228-6710
    • Cottingham, England, United Kingdom, HU16 5JQ
      • Recruiting
      • Castle Hill Hospital
      • Contact: Contact Person; Phone Number: 44-1482-659-331
    • Crewe, England, United Kingdom, CW1 4QJ
      • Recruiting
      • Mid Cheshire Hospitals Trust- Leighton Hopsital
      • Contact: Contact Person; Phone Number: 44-1270-255-141
    • Croydon, England, United Kingdom
      • Recruiting
      • Mayday University Hospital
      • Contact: Contact Person; Phone Number: 44-20-8401-3000
    • Dartford Kent, England, United Kingdom, DA2 8DA
      • Recruiting
      • Darent Valley Hospital
      • Contact: Contact Person; Phone Number: 44-1322-428-500
    • Derby, England, United Kingdom, DE22 3NE
      • Recruiting
      • Royal Derby Hospital
      • Contact: Contact Person; Phone Number: 44-1332-340-131
    • Dudley, England, United Kingdom, DY1 2HQ
      • Recruiting
      • Russells Hall Hospital
      • Contact: Contact Person; Phone Number: 44-1384-456-111
    • Grantham, Lincolnshire, England, United Kingdom, NG31 8DG
      • Recruiting
      • Grantham and District Hospital
      • Contact: Contact Person; Phone Number: 44-1476-565-232
    • Harrogate, England, United Kingdom, HG2 7SX
      • Recruiting
      • Harrogate District Hospital
      • Contact: Contact Person; Phone Number: 44-1423-885-959
    • Harrow, England, United Kingdom, HA1 3UJ
      • Recruiting
      • St. Mark's Hospital
      • Contact: Contact Person; Phone Number: 44-20-8235-4000
    • High Wycombe, England, United Kingdom
      • Recruiting
      • Wycombe General Hospital
      • Contact: Contact Person; Phone Number: 44-1494-426-234
    • Huntingdon, England, United Kingdom, PE18 6NT
      • Recruiting
      • Hinchingbrooke Hospital
      • Contact: Contact Person; Phone Number: 44-1480-416-416
    • Isleworth, England, United Kingdom, TW7 6AF
      • Recruiting
      • West Middlesex University Hospital
      • Contact: Contact Person; Phone Number: 44-20-8560-2121
    • Leeds, England, United Kingdom, LS1 3EX
      • Recruiting
      • Leeds General Infirmary
      • Contact: Contact Person; Phone Number: 44-113-243-2799
    • London, England, United Kingdom, W6 8RF
      • Recruiting
      • Charing Cross Hospital
      • Contact: Contact Person; Phone Number: 44-20-8846-1234
    • Maidstone, England, United Kingdom, ME16 9QQ
      • Recruiting
      • Mid Kent Oncology Centre at Maidstone Hospital
    • Nottingham, England, United Kingdom, NG7 2UH
      • Recruiting
      • Queen's Medical Centre
      • Contact: Contact Person; Phone Number: 44-115-924-9924
    • Plymouth, England, United Kingdom, PL6 8DH
      • Recruiting
      • Derriford Hospital
      • Contact: Contact Person; Phone Number: 44-175-277-7111
    • Scarborough, England, United Kingdom, YO12 6QL
      • Recruiting
      • Scarborough General Hospital
      • Contact: Contact Person; Phone Number: 44-1723-342-175
    • Shrewsbury, England, United Kingdom, SY3 8XQ
      • Recruiting
      • Royal Shrewsbury Hospital
      • Contact: Contact Person; Phone Number: 44-1743-261-000
    • Slough, Berkshire, England, United Kingdom, SL2 4HL
      • Recruiting
      • Wexham Park Hospital
      • Contact: Contact Person; Phone Number: 44-1753-634-191
    • Solihull, England, United Kingdom, B91 2JL
      • Recruiting
      • Solihull Hospital
      • Contact: Contact Person; Phone Number: 44-121-424-2000
    • Southampton, England, United Kingdom, SO16 6YD
      • Recruiting
      • Southampton General Hospital
    • Surrey, England, United Kingdom, KT 16 OPZ
      • Recruiting
      • St. Peter's Hospital
      • Contact: Contact Person; Phone Number: 44-1932-722-233
    • Truro, Cornwall, England, United Kingdom, TR1 3LJ
      • Recruiting
      • Royal Cornwall Hospital
      • Contact: Contact Person; Phone Number: 44-1872-250-000
    • Uxbridge, England, United Kingdom, UB8 3NN
      • Recruiting
      • Hillingdon Hospital
      • Contact: Contact Person; Phone Number: 44-1895-238-282
    • Warrington, England, United Kingdom, WA5 1QG
      • Recruiting
      • Warrington Hospital NHS Trust
      • Contact: Contact Person; Phone Number: 44-1925-635-911
    • Worcester, England, United Kingdom, WR5 1DD
      • Recruiting
      • Worcester Royal Hospital
      • Contact: Contact Person; Phone Number: 44-1905-760-719

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival by intention-to-treat analysis

Secondary Outcome Measures

Outcome Measure
Quality of life
Cost of National Health Service (NHS) services utilized
NHS cost per life-year saved

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Investigators: Study Chair: John N. Primrose, MD, University Hospital Southampton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: November 16, 2007
• First Submitted That Met QC Criteria: November 16, 2007
• First Posted (Estimate): November 19, 2007

Study Record Updates

• Last Update Posted (Estimate): August 8, 2011
• Last Update Submitted That Met QC Criteria: August 5, 2011
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: stage III colon cancer; stage II rectal cancer; stage III rectal cancer; stage II colon cancer; stage I rectal cancer; stage I colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CDR0000576476; USCTU-FACS; ISRCTN41458548; EU-20788