Plain English Summary
http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-followup-after-colorectal-surgery
Trial website
Contact information
Type
Scientific
Primary contact
Prof John Primrose
ORCID ID
Contact details
School of Medicine
University of Southampton
Biomedical Sciences Building
Bassett Crescent East
Southampton
SO16 6YD
United Kingdom
+44 2380 796144
j.n.primrose@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 99/10/09
Study information
Scientific title
Acronym
FACS (Follow-up After Colorectal Surgery)
Study hypothesis
Aim: To assess the cost-effectiveness of intensive versus no scheduled follow-up in patients who have undergone resection for colorectal cancer with curative intent.
Objectives:
1. To confirm the feasibility of recruiting 5000 participants from 20 centres to the trial in two years.
2. To assess the effectiveness and cost-effectiveness of serial blood CEA measurement in detecting treatable recurrence and thereby improving 5 year survival.
3. To assess the effectiveness and cost-effectiveness of hospital follow-up involving regular ultrasound and CT imaging compared with no imaging and follow-up in general practice in detecting treatable recurrence and thereby improving 5 year survival.
Details of this study can also be found at: http://www.hta.ac.uk/1229
The ISRCTN record of main FACS trial that followed this pilot study can be found at: http://www.controlled-trials.com/ISRCTN41458548.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer (neoplasms): Rectum; Cancer (neoplasms): Colon
Intervention
Monitoring of carcinoembryonic antigen (CEA) in primary care vs intensive imaging in hospital.
Follow-up after 3 months.
See details of ISRCTN41458548: FACS main trial on http://www.controlled-trials.com/isrctn/trial/ISRCTN41458548/0/41458548.html
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/09/2002
Overall trial end date
29/02/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients who have undergone resection for colorectal cancer with curative intent.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Not provided at time of registration.
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/09/2002
Recruitment end date
29/02/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Medicine
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
No publication intended as of 06/10/2009