ASCOLT

Protocol Title:  Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers, An international, Multicentre, Double Blind, Randomised Placebo Controlled Phase III Trial.

Study Chairs:   Dr Mark Jeffrey (Christchurch Hospital, New Zealand); and A/Prof Eva Segelov  (St Vincent’s Hospital, Sydney NSW)

Associate Oncology Program Manager: Christine Aiken

Trial Coordinator:  Christine Aiken

Contact Email:  ascolt@ctc.usyd.edu.au

Detailed information  available  on:  Australian and New Zealand Clinical Trials Registry – ASCOLT  

Trial Newsletter: None to date

Grants Awarded:
Cancer Australia Grant: $328,000 (2014)

Aim:  
The ASCOLT Study (Aspirin for Dukes C and high risk B COLorecTal cancer) is an international collaborative group randomised clinical phase III trial investigating the utility of low dose aspirin on improving disease free and overall survival in patients with resected Stage III (Dukes C) and high risk Stage II (Dukes B) colorectal cancer.

Background:  
This study is the first to evaluate aspirin as adjuvant therapy in established cancers, and has been tipped as one of the most important gastrointestinal cancer studies globally.   In 2012, the National Cancer Institute of U.S listed aspirin’s role in cancer as one of the most provocative questions in cancer research. The AGITG has also recently ranked “Aspirin in Colorectal Cancer” — as the top research priority in gastrointestinal cancer, and has therefore committed to recruiting for ASCOLT. The trial is led by an international collaboration from Singapore, UK and Australia.

Study Design:

A total of 200 eligible patients from 20-25 sites across Australia and New Zealand will be randomised to receive 3 years of treatment with either aspirin or placebo followed by 2 years post treatment follow up.

Objectives:

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 and Overall Survival.

To view  study schema click here.

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