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

Colorectal Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00560365
• Other study ID #: CDR0000576476
• Secondary ID: USCTU-FACSISRCTN
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2007
• Last updated: August 5, 2011
• Start date: March 2004

Study information

• Verified date: August 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4760
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• laboratory biomarker analysis

Procedure:
• computed tomography

• magnetic resonance imaging

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	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	Grantham and District Hospital	Grantham, Lincolnshire	England
United Kingdom	Harrogate District Hospital	Harrogate	England
United Kingdom	St. Mark's Hospital	Harrow	England
United Kingdom	Wycombe General Hospital	High Wycombe	England
United Kingdom	Hinchingbrooke Hospital	Huntingdon	England
United Kingdom	West Middlesex University Hospital	Isleworth	England
United Kingdom	Leeds General Infirmary	Leeds	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Mid Kent Oncology Centre at Maidstone Hospital	Maidstone	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Scarborough General Hospital	Scarborough	England
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury	England
United Kingdom	Wexham Park Hospital	Slough, Berkshire	England
United Kingdom	Solihull Hospital	Solihull	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	St. Peter's Hospital	Surrey	England
United Kingdom	Royal Cornwall Hospital	Truro, Cornwall	England
United Kingdom	Hillingdon Hospital	Uxbridge	England
United Kingdom	Warrington Hospital NHS Trust	Warrington	England
United Kingdom	Worcester Royal Hospital	Worcester	England

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival by intention-to-treat analysis			No
Secondary	Quality of life			No
Secondary	Cost of National Health Service (NHS) services utilized			No
Secondary	NHS cost per life-year saved			No