AGITG Trial updates: October 2020


The FORECAST-1 trial investigating personalised treatments for advanced colorectal cancer has opened and the first two patients have joined the study.

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.

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. This community support and fundraising enables the AGITG to offer the Innovation Fund each year.

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 the first step in opening up new treatment opportunities and giving every patient the best possible care.

Learn more about FORECAST-1 here.



The NABNEC study for patients with advanced gastrointestinal neuroendocrine carcinomas (NECs) is currently open at 17 sites across all six states in Australia, It aims to determine the safety and efficacy of carboplatin plus nab-paclitaxel in comparison to the current standard chemotherapy plan (carboplatin plus etoposide) and find the most promising treatment for advanced gastrointestinal NECs.

The chemotherapy currently available for people with high grade neuroendocrine cancers results in responses of a short duration. After the initial response patients often relapse within a few months, and less than 5% of patients have a survival outcome of more than five years.

Amendments have been made to the protocol for NABNEC to change the recruitment target to 58 and remove the control arm of the trial. These changes have been made to ensure that the trial reaches an achievable, statistically relevant trial result as recruitment has been slower than forecasted. Recruitment has also been extended until June 2021.

The trial is over halfway to its enrolment target, with 41 participants currently enrolled. As gastrointestinal NECs are so rare, recruitment has been gradual. Previous protocol amendments were made to NABNEC in 2019, with inclusion criteria being adapted to maximise inclusiveness for patients with NECs.

“Although the trial is recruiting a rare cancer population, enrolment has picked up in the last twelve months and we have now reached over half of the enrolment target,” says Dr Lorraine Chantrill, Principal Investigator of the trial.

NABNEC is also exploring translational biologic, molecular and functional imaging endpoints to inform future research.

Learn more about NABNEC 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 25 patients are enrolled across Australia.

Learn more about MONARCC here.



Low-dose aspirin could play an important role in reducing the recurrence of colorectal cancer. The ASCOLT study is an international phase III trial that aims to discover whether taking a daily 200mg dose of aspirin for three years could help to prevent colorectal cancer returning in people who have already been successfully treated.

ASCOLT is led by Dr Mark Jeffrey, who says the trial is “A great example of a trial re-examining the potential effectiveness of a well-known common medication (aspirin in this case) which may have a significant effect on survival in colorectal cancer.”

“The survival rates in early colorectal cancer have plateaued in recent years and a positive result from this trial would have very broad and enduring impact.”

So far, 441 patients have joined the study with only another 19 patients needed to complete recruitment.

Learn more about ASCOLT here.



The purpose of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting in patients with resectable gastric cancer.

TOPGEAR is an international, phase II/III trial involving 66 sites in 15 countries across Australasia, Europe and Canada. It is an intergroup trial being conducted as a collaboration between the AGITG, TROG (Trans-Tasman Radiation Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer), and the CCTG (Canadian Cancer Trials Group).

“The trial is in the final stages of recruitment and with over 500 patients recruited, it is already the largest trial evaluating preoperative chemoradiation for gastric cancer,” says Professor Leong. “TOPGEAR continues to generate considerable interest at international meetings and the results are eagerly awaited by clinicians worldwide.”

International clinical trials are a vital method of conducting research into diseases that affect patients worldwide. This means that new therapies can be made available to patients around the world at the same time, and this trial has the potential to change practice on a global scale.

So far, 547 patients have joined the study, with only another 23 patients needed to complete global recruitment by the end of this year.

Learn more about TOPGEAR here.