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 - pilot study

ISRCTN	ISRCTN61091474
DOI	https://doi.org/10.1186/ISRCTN61091474
Secondary identifying numbers	HTA 99/10/09

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 30/05/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-followup-after-colorectal-surgery

Study website

Contact information

Prof John Primrose
Scientific

School of Medicine
University of Southampton
Biomedical Sciences Building
Bassett Crescent East
Southampton
SO16 6YD
United Kingdom

Phone	+44 2380 796144
Email	j.n.primrose@soton.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	FACS (Follow-up After Colorectal Surgery)
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/09/2002
Completion date	29/02/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	Not provided at time of registration.
Key inclusion criteria	Patients who have undergone resection for colorectal cancer with curative intent.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/09/2002
Date of final enrolment	29/02/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Medicine

Southampton
SO16 6YD
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan