AGITG clinical trials:  ASCOLT

ASCOLT is a trial of Aspirin for Dukes C and high risk Dukes B colorectal (bowel) cancers. It is an international, multi-centre, double blind, randomised placebo-controlled, phase III trial.  ASCOLT is investigating the effectiveness of low-dose aspirin on improving survival in patients who have had surgery for a Duke C or high risk Dukes B cancer, hypothesising a reduction in cancer recurrence and/or secondary cancers that can occur up to five years after this initial surgery.

The worldwide research collaboration is led by researchers in Singapore, UK and Australia; the Australian effort led by the AGITG.

Aspirin’s role in cancer is one of the most prominent questions in current cancer research. Low doses of aspirin have recently been found to reduce the risk of gastro-intestinal cancers.  ASCOLT is the first prospective study to evaluate aspirin’s use as a treatment to prevent recurrence after surgery and chemotherapy, and is tipped as one of the most important current cancer studies globally.

A total of 200 eligible patients from more than twenty sites across Australia and New Zealand will receive three years of treatment with either aspirin or placebo, followed by two years’ post-treatment follow-up.

Cancer type:   Colorectal (bowel)
Trial status:  Open to patient participation
Eligibility:   The trial is seeking to recruit anyone who has undergone surgery and then chemotherapy for bowel cancer, and is not either already on aspirin or has a contraindication to its use — such as people on anti-ulcer or anti-reflux medication.
For more information: click here for summary    

AGITG clinical trials:

ICECREAM aims to provide important data on the optimal use of currently available therapeutics in patients with metastatic CRC (bowel or rectal cancer) who have progressed on standard chemotherapy options. The trial is designed to study two questions in parallel.

First, to determine whether cetuximab is optimally used as monotherapy or in combination with an irinotecan-based regimen in certain patients, without particular mutations of interest, and the second, to determine whether the efficacy of either cetuximab alone or in combination with an irinotecan-based regimen is similar in patients harbouring a particular mutation, as suggested by prior studies. The results will impact the standard treatment for both groups of patients and may influence the policy on the use of cetuximab based on an improved understanding of the most suitable patients to have access to cetuximab in Australia.

Cancer type:   Colorectal (bowel)
Trial status:    In follow-up
For more information: click here for summary.    

AGITG clinical trials:  CO.23

CO.23 is an international, multi-centre, prospective, double-blind, randomised phase III trial in patients previously treated with combination chemotherapy for advanced bowel cancer. Patients will be assigned to best supportive care and a cancer stem cell inhibitor BBI608, or best supportive care and placebo. Best supportive care includes measures designed to provide palliation of symptoms and improve quality of life as much as possible.

In Australia, bowel cancer is the second most common cancer diagnosed, and the second highest cause of cancer related death. Approximately half of those diagnosed with bowel cancer will develop disseminated, advanced disease which in most cases is fatal.

Cancer Stem Cells (CSCs) are a sub-population of cancer cells that have self-renewal capability, are highly malignant and are considered to be fundamentally responsible for malignant growth, recurrence, drug-resistance and metastases. Moreover, CSCs are highly resistant to chemotherapies and current targeted agents. Findings suggest that inhibitors of CSC improve outcomes for patients.

CO.23 will primarily examine the effect of treatment with the CSC inhibitor BBI608 on overall survival in patients whose bowel cancer has spread despite treatment with all standard chemotherapies recommended by their oncologist, and for whom no standard anti-cancer therapy is available.

Cancer type:  
Colorectal (bowel)
Trial status:  In follow-up
For more information: click here for the summary.

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