Background: The ASCOLT study is an international randomised phase III trial investigating the effect of aspirin as additional adjuvant treatment on disease free survival (DFS) and overall survival (OS) in patients with resected stage II and III colorectal cancer (CRC).
Evidence is emerging that aspirin 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 CRC by 40-50 percent. Randomised trials performed in patients at high risk for colorectal cancer reported that aspirin can reduce the development of polyps and the incidence of CRC. Although several cohort studies have suggested that subsequent aspirin usage 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. To be considered standard of care, it is essential that robust, prospective trial evidence of efficacy, safety and compliance is obtained.
Methods: Planned to recruit 1200 patients by December 2017 from 58 sites in 12 countries including 26 Australian and 2 New Zealand sites. Eligible patients have completely resected primary Dukes C or high risk Dukes B colorectal cancer, completed standard therapy and imaging within 16 months prior to randomisation. Patients are randomised to receive either aspirin 200mg or placebo for 3 years. Primary endpoint is DFS; secondary endpoint OS over 5 years.
Analysis of genetic changes in colorectal cancers that predict cancer recurrence and prognosis will be part of the translational activities being led by Australian investigators on the collected tissue and blood samples.
Status: Currently 904/1200 patients recruited internationally. ANZ have contributed 163 patients to date. The inclusion of Telehealth to improve participation for rural and remote Australians is being assessed.