Condition category
Cancer
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
30/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

No publication intended as of 06/10/2009

Publication citations

Additional files

Editorial Notes