ASCOLT: Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-centre, Double Blind, Randomised Placebo Controlled Phase III Trial

Aspirin is a cost-effective and familiar medication. Evidence is emerging that it has anticancer properties, particularly in gastrointestinal cancers. Indirect evidence from five meta-analyses of randomised trials in patients with vascular disease showed that long term use of aspirin reduces the primary incidence of colorectal cancer (CRC) by about 40-50%. Randomised trials performed in patients at high risk for CRC reported that aspirin can reduce the development of polyps (the precursors of CRC) as well as the incidence of CRC. Although several cohort studies have suggested that aspirin improves survival in patients with localised CRC, prospective evaluation of the benefit of aspirin as an adjuvant agent in patients with a history of CRC has yet to be conducted.

ASCOLT aims to assess the effectiveness of aspirin against placebo control in patients with Dukes C or high risk Dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall Survival (OS). The primary endpoint is DFS, with secondary objectives including OS at 5 years, DFS and OS in different ethnic groups, cancer sub-groups and compliant versus non-compliant patients.