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 |
| Protocol serial number | HTA 99/10/09 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Contact information
Prof John Primrose
Scientific
Scientific
School of Medicine
University of Southampton
Biomedical Sciences Building
Bassett Crescent East
Southampton
SO16 6YD
United Kingdom
| Phone | +44 2380 796144 |
|---|---|
| j.n.primrose@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 29/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
School of Medicine
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
