The ASCOLT trial is an international clinical trial investigating the effect of aspirin on disease-free survival and overall survival as adjuvant treatment in patients with resected Stage II and III colorectal cancer (CRC). Evidence is emerging that aspirin has anticancer properties, particularly in gastro-intestinal cancers. High-quality evidence from earlier clinical trials showed that long-term use of aspirin can reduce the development of polyps, the precursors of CRC, and the incidence of CRC. However, although several studies have suggested that aspirin improves survival in patients with a diagnosis of localised CRC, evidence on the benefit of aspirin as an adjuvant agent in patients with a history of CRC is still lacking. The ASCOLT study aims to provide definitive proof of the role of aspirin in secondary prevention of CRC.


Tele-trial model allows rural patients to join the ASCOLT trial

Rural patients often have trouble accessing clinical trials closer to home due to the limited availability of clinical trial sites in rural and regional areas. Moreover, access to distant clinical trial sites involves long-distance travel and the associated expenses, which pose barriers to participation in clinical trials for rural and regional patients. The tele-trial model, proposed by the Clinical Oncology Society of Australia (COSA), can offer an opportunity to rural and regional patients to access clinical trials. This model allows the principal investigator from an established oncology clinical trial centre (primary site), to consent, recruit and manage patients from a rural and regional centre (remote site). Patients and clinicians at the remote site link to the primary site via videoconference in real time, where the principal investigator and trial staff ensure that all trial procedures are completed.

The ASCOLT trial is piloting the tele-trial model with Orange Hospital as the primary site and Dubbo Hospital as a remote site to enable participation of patients in rural and remote New South Wales. This model has proven highly successful in ASCOLT. Since activation in October 2017, three patients have been recruited at the Orange–Dubbo tele-trial site. The patients and clinical staff from both Orange and Dubbo have been extremely enthusiastic.

See ANZCTR for full trial details >


Trial Summary:

The study objectives are 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).

Supported By:

Cancer Australia and Bowel Cancer Australia


  • Adults (18 years or over) with high-risk stage II and III colorectal cancer (Dukes C colon cancer, high-risk Dukes B colon cancer, Dukes C rectal cancer, or Dukes B rectal cancer)
  • Has undergone complete resection to remove the primary tumour
  • Completed at least 3 months of chemotherapy, with or without radiotherapy
  • Within 120 days of completion of standard therapy (surgery or chemotherapy with or without radiotherapy)
  • Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation)
  • Willing to follow all study requirements, including treatment, timing of required assessments and follow-up.

Registration ID:



Australia and New Zealand

Australian Lead Group:




Activation Date:



Dr Mark Jeffrey and A/Prof Eva Segelov