Condition category
Cancer
Date applied
18/05/2004
Date assigned
18/05/2004
Last edited
17/01/2014
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

Professor of Surgery
F Level
Centre Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 80 796144
j.n.primrose@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00560365

Protocol/serial number

HTA 99/10/99

Study information

Scientific 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 - main trial

Acronym

FACS (Follow-up After Colorectal Surgery)

Study hypothesis

Colorectal cancer is a major health problem. In the UK, each year about 32,000 cases are diagnosed annually and 17,000 deaths are attributed to the disease. Surgery is the mainstay of treatment and traditionally patients who have curative surgery for colorectal cancer are subject to long-term follow up. Various protocols are used by surgeons but few, if any, are evidence based. The costs to the NHS of follow-up are substantial and they need to be justified by evidence of cost-effectiveness.
Whilst a number of previous studies have assessed the value of follow up of patients with curatively resected colorectal cancer, none provides a definitive answer. This trial aims to do so. FACS is a Multicentre, randomised, controlled, intention to treat with a 2x2 factorial design. Patients randomised to 1 of 4 arms.

Details of the study can also be found at: http://www.hta.ac.uk/1389
FACS pilot on http://www.controlled-trials.com/ISRCTN61091474

Please note that extensive amendments have been made to this trial records as of 09/02/2009. They include the following:
1. The anticipated end date of this trial has been updated from 31/03/2011 to 31/08/2009.
2. The target number of participants has been amended from 4,760 to 1,000.
Other changes are recorded in the relevant fields.

Ethics approval

South West Research Ethics Committee (formerly SWMREC), approved on 04/02/2002 (ref: MREC/01/6/91)

Study design

Multi-centre randomised controlled trial, intention to treat with a 2 x 2 factorial design

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

Colorectal cancer

Intervention

Monitoring of carcinoembryonic antigen (CEA) in primary care vs intensive imaging in hospital.

Patients randomised to 1 of 4 arms:
Arm 1: Symptomatic follow-up in primary care
Arm 2: CEA in primary care, 3 monthly for 2 years and 6 monthly for another 3 years.
Arm 3: Hospital based imaging with CT 6 monthly for 2 years and annually for another 3 years.
Arm 4: Combination of 2 and 3

All groups: Given patient handbook detailing symptoms suggestive of recurrence, colonoscopy at trial end (5 years). Contact with Colorectal Nurse Specialist can continue.

Groups 3 and 4: Additional colonoscopy at year 2.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measure amended as of 11/02/2009:
Number of recurrences in each group treated surgically with curative intent, analysed at study end (5 years).

Previous primary outcome measure:
Overall survival by intention to treat analysis.

Secondary outcome measures

Current secondary outcome measures as of 11/02/2009:
1. Overall survival by intention to treat analysis, reviewed at study end (5 years)
2. Quality of life in survivors, assessed at baseline, and then at the end of study years 1-5 by the following:
2. 1. Euroqol EQ-5D
2. 2. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30)
2. 3. Hospital Anxiety and Depression (HAD) scale
2. 4. Modified form of a College of Health Questionnaire
2. 5. A small number of items from the 7-item questionnaire used by Kjeldsen
3. Cost of NHS services utilised, data are collected at the end of study years 1-5 for all patients
4. NHS cost per life-year saved, assessed at study end (5 years)

Previous secondary outcome measures:
1. Quality of life in survivors
2. Cost of NHS services utilised
3. NHS cost per life-years saved

Overall trial start date

01/04/2004

Overall trial end date

31/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who have undergone resection for colorectal cancer with curative intent

Added as of 23/01/2009:
Both males and females, 50 years and older

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

1,000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2004

Recruitment end date

31/08/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor of Surgery
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

University Road
Southampton
SO17 1BJ
United Kingdom

Sponsor type

Government

Website

http://www.soton.ac.uk/

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24430319

Publication citations

  1. Results

    Primrose JN, Perera R, Gray A, Rose P, Fuller A, Corkhill A, George S, Mant D, , Effect of 3 to 5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer: the FACS randomized clinical trial., JAMA, 2014, 311, 3, 263-270, doi: 10.1001/jama.2013.285718.

Additional files

Editorial Notes