December 2020: Trial Updates


The OXTOX trial for patients with metastatic colorectal cancer, led by Professor Janette Vardy, is opening this week at Concord Cancer Centre and at another 4 sites across NSW shortly thereafter.

Chemotherapy-induced peripheral neuropathy (CIPN), is characterised by pins and needles and pain in the hands and feet. It is a common side effect of oxaliplatin, the chemotherapy treatment commonly used in colorectal cancer treatment. It has a major impact on quality of life, functional status and return to daily life, and there is currently no effective prevention or treatment. It is the most common reason for patients stopping or reducing oxaliplatin treatment early.

OXTOX is a randomised (2:1) phase II study in 90 people to evaluate whether ibudilast decreases the severity of acute neuropathy and enables people with metastatic colorectal cancer to get more oxaliplatin before needing dose modifications for chemotherapy-induced peripheral neuropathy.

“We actually did some data from our Survivorship clinic, and in patients who had received oxaliplatin, 46% of them were reporting at least 4/10 severity of numbness or tingling and that was an average of nine months after they’d finished treatment,” Professor Vardy says.

The trial was funded by the AGITG Innovation Fund grant in 2018. This is a unique grant funded through community fundraising, enabling AGITG members to conduct vital small-scale studies to impact future clinical practice.

“If the results of this trial are positive, it has the potential to improve patients’ quality of life, and maybe even improve their survival if it means they’re able to receive the desired dose of chemotherapy. So we’re very grateful for the opportunity to be able to do that,” Professor Vardy says.

Find out more about OXTOX here.



There is a large unmet need for people with metastatic colorectal cancer when standard therapy fails. Professor Peter Gibbs and his team are addressing this by using new technology to grow Patient-Derived Tumour Organoids (PDTOs) from biopsies of patients’ tumour tissue.

This is part of the FORECAST-1 study, which opened for patient enrolment in September. Ten patients have now joined the study, a third of the enrolment target of 30 patients.

Professor Gibbs was the recipient of the 2019 Innovation Fund grant for FORECAST-1. He received a grant of $200,000, which was funded by the community through donations and the Gutsy Challenge.

By growing organoids in the lab, the research team can model the effectiveness of anti-cancer treatments on individual cancers in a petri-dish, better tailoring each patient’s treatment. FORECAST-1 will investigate the effectiveness of this approach for patients when other treatments are no longer effective, but Professor Gibbs hopes that it could be used in the future to determine the best therapeutic approach for people who have not yet been treated.

“One of the dilemmas that we have as more and more new treatments become available is for each individual patient – what is the best treatment for them? In the future I’d hope that we could grow organoids in the laboratories, and use them to test precisely which is the best treatment for each patient,” says Professor Gibbs.

FORECAST-1 is currently open at Melbourne Private Hospital, Box Hill Hospital and Sunshine Hospital.

Find out more about FORECAST-1 here.



Elderly patients are at a high risk of colorectal cancer, but may not be able to tolerate current chemotherapy treatments. The aim of the MONARCC trial, led by Dr Matthew Burge, is to investigate the activity of anti-EGFR monotherapy, or combined with infusional 5FU, in a molecularly selected, elderly patient population with metastatic colorectal cancer.


Patients with metastatic colorectal cancer who are aged 70 years or over may be eligible to participate in MONARCC. Currently 28 patients are enrolled across Australia.

Learn more about MONARCC here.


Recent sites activated

DYNAMIC-Pancreas Royal North Shore Hospital
Westmead Hospital
Liverpool Hospital
MASTERPLAN Calvary Mater Newcastle
MONARCC Bundaberg Hospital
RENO Chris O’Brien Lifehouse