Colorectal CancerNCT00560365
Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer
An observational study of Colorectal Cancer, run by University Hospital Southampton NHS Foundation Trust at 31 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- laboratory biomarker analysis, computed tomography and magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 4,760 participants
- Where
- 31 sitesUnited Kingdom
- Study dates
- Mar 2004to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United Kingdom31 sites, 31 recruiting
- Recruiting
Queen's Hospital
Burton-on-Trent, England, DE13 0RB
Contact Person, 44-1283-566-333
- Recruiting
Cumberland Infirmary
Carlisle, England, CA2 7HY
Contact Person, 44-1228-523-444
- Recruiting
Saint Richards Hospital
Chichester, England, P019 4SE
Contact Person, 44-1243-788-122
- Recruiting
Queen Alexandra Hospital
Cosham, England, PO6 3LY
Contact Person, 44-23-9228-6710
- Recruiting
Castle Hill Hospital
Cottingham, England, HU16 5JQ
Contact Person, 44-1482-659-331
- Recruiting
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, CW1 4QJ
Contact Person, 44-1270-255-141
- Recruiting
Mayday University Hospital
Croydon, England
Contact Person, 44-20-8401-3000
- Recruiting
Darent Valley Hospital
Dartford Kent, England, DA2 8DA
Contact Person, 44-1322-428-500
- Recruiting
Royal Derby Hospital
Derby, England, DE22 3NE
Contact Person, 44-1332-340-131
- Recruiting
Russells Hall Hospital
Dudley, England, DY1 2HQ
Contact Person, 44-1384-456-111
- Recruiting
Grantham and District Hospital
Grantham, Lincolnshire, England, NG31 8DG
Contact Person, 44-1476-565-232
- Recruiting
Harrogate District Hospital
Harrogate, England, HG2 7SX
Contact Person, 44-1423-885-959
- Recruiting
St. Mark's Hospital
Harrow, England, HA1 3UJ
Contact Person, 44-20-8235-4000
- Recruiting
Wycombe General Hospital
High Wycombe, England
Contact Person, 44-1494-426-234
- Recruiting
Hinchingbrooke Hospital
Huntingdon, England, PE18 6NT
Contact Person, 44-1480-416-416
- Recruiting
West Middlesex University Hospital
Isleworth, England, TW7 6AF
Contact Person, 44-20-8560-2121
- Recruiting
Leeds General Infirmary
Leeds, England, LS1 3EX
Contact Person, 44-113-243-2799
- Recruiting
Charing Cross Hospital
London, England, W6 8RF
Contact Person, 44-20-8846-1234
- Recruiting
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, ME16 9QQ
Contact Person, 44-1622-729-000
- Recruiting
Queen's Medical Centre
Nottingham, England, NG7 2UH
Contact Person, 44-115-924-9924
- Recruiting
Derriford Hospital
Plymouth, England, PL6 8DH
Contact Person, 44-175-277-7111
- Recruiting
Scarborough General Hospital
Scarborough, England, YO12 6QL
Contact Person, 44-1723-342-175
- Recruiting
Royal Shrewsbury Hospital
Shrewsbury, England, SY3 8XQ
Contact Person, 44-1743-261-000
- Recruiting
Wexham Park Hospital
Slough, Berkshire, England, SL2 4HL
Contact Person, 44-1753-634-191
- Recruiting
Solihull Hospital
Solihull, England, B91 2JL
Contact Person, 44-121-424-2000
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
Contact Person, 44-23-8079-8751
- Recruiting
St. Peter's Hospital
Surrey, England, KT 16 OPZ
Contact Person, 44-1932-722-233
- Recruiting
Royal Cornwall Hospital
Truro, Cornwall, England, TR1 3LJ
Contact Person, 44-1872-250-000
- Recruiting
Hillingdon Hospital
Uxbridge, England, UB8 3NN
Contact Person, 44-1895-238-282
- Recruiting
Warrington Hospital NHS Trust
Warrington, England, WA5 1QG
Contact Person, 44-1925-635-911
- Recruiting
Worcester Royal Hospital
Worcester, England, WR5 1DD
Contact Person, 44-1905-760-719
About this study
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)
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- laboratory biomarker analysis, computed tomography, magnetic resonance imaging, quality-of-life assessment
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
computed tomographyProcedure or surgery
magnetic resonance imagingProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival by intention-to-treat analysis
Secondary outcomes (3)
Quality of life
Cost of National Health Service (NHS) services utilized
NHS cost per life-year saved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startMar 2004
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 4,760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- John N. Primrose, MD, Study chair, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560365
- Sponsor's protocol ID
- CDR0000576476
- Other IDs
- USCTU-FACS, ISRCTN41458548, EU-20788
- Status last verified
- Aug 2009
- First submitted
- 16 Nov 2007
- Last updated
- 8 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00560365
- Acronym / sponsor ID
- CDR0000576476
- Conditions
- Colorectal Cancer
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,760 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Dec 2013 (estimated)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| computed tomography | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Overall survival by intention-to-treat analysis
3 secondary outcomes
Quality of life
Cost of National Health Service (NHS) services utilized
NHS cost per life-year saved
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John N. Primrose, MD study chair
University Hospital Southampton NHS Foundation Trust
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University Hospital Southampton NHS Foundation Trust at 31 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival by intention-to-treat analysis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2011.