Trial Name:
FACS Trial - 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.
Description:
The aim of this trial is to determine the best way of following up patients who have had successful treatment for colorectal cancer. Follow-up strategies for patients vary enormously from intensive monitoring to symptomatic follow-up by a General Practitioner. The cost implication to the NHS of intensive follow-up is very large. Several randomised trials of follow-up summarised in the Cochrane review show only small or no benefit of intensive follow-up.
Objectives:
To assess the effect of augmenting symptomatic follow-up in primary care with two intensive methods of follow-up (monitoring of tumour marker in primary care and intensive imaging in hospital) on the number of recurrences treated surgically with curative intent.
Primary objective:
- Number of recurrences treated surgically with curative intent by intention-to-treat analysis.
Secondary objectives:
- Overall survival;
- Quality of life in survivors;
- Cost of NHS services utilised;
- NHS cost per life-year saved.
Design:
Multicentre, randomised, controlled, intention to treat, 2x2 factorial design clinical trial. The clinician must decide pre-randomisation whether the patient has a certain/uncertain need for imaging follow-up.
Status:
Completed.
Population:
All patients who have undergone curative treatment for primary colorectal cancer (R0 resections, Dukes A-C).
Publications:
Contact details:
All Trial enquiries should be addressed to ctu@soton.ac.uk
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This trial was funded by a Health Technology Assessment (HTA) grant from the NIHR (award reference no. NIHR 99/10/09)