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

• Conditions: Colorectal Cancer

• Registration Number: NCT00560365
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study Start: 2004-03
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Status Verified: 2009-08
• Last Update Submitted: 2011-08-05
• Last Update Posted: 2011-08-08
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4760

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival by intention-to-treat analysis

Secondary Outcome Measures

Name	Time	Method
Quality of life
Cost of National Health Service (NHS) services utilized
NHS cost per life-year saved

Trial Locations

Locations (31)

Queen's Hospital; 🇬🇧 Burton-upon-Trent, England, United Kingdom

Cumberland Infirmary; 🇬🇧 Carlisle, England, United Kingdom

Saint Richards Hospital; 🇬🇧 Chichester, England, United Kingdom

Queen Alexandra Hospital; 🇬🇧 Cosham, England, United Kingdom

Castle Hill Hospital; 🇬🇧 Cottingham, England, United Kingdom

Mid Cheshire Hospitals Trust- Leighton Hopsital; 🇬🇧 Crewe, England, United Kingdom

Mayday University Hospital; 🇬🇧 Croydon, England, United Kingdom

Darent Valley Hospital; 🇬🇧 Dartford Kent, England, United Kingdom

Royal Derby Hospital; 🇬🇧 Derby, England, United Kingdom

Russells Hall Hospital; 🇬🇧 Dudley, England, United Kingdom

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