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The University of Southampton
Southampton Clinical Trials Unit

FACS

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:

Secondary objectives:

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:

Site and stage of colorectal cancer influence the likelihood and distribution of disease recurrence and postrecurrence survival: data from the FACS randomized controlled trial

Effect of 3 to 5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer: the FACS randomized clinical trial

Contact details:

All Trial enquiries should be addressed to ctu@soton.ac.uk

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