September 2020: Trial Updates


The pilot study Neo-CREATE, led by study chair Dr Amitesh Roy, aims to assess the safety of adding the immunotherapy drug avelumab to chemo-radiation using two standard chemotherapy drugs, carboplatin and paclitaxel, before surgery in patients with cancers of the oesophagus or the gastro-oesophageal junction. Eight participants are currently enrolled in the study out of an enrolment target of 80.

“Neo-CREATE is a feasibility study with a safety lead-in investigating the role of immunotherapy in conjunction with chemotherapy and radiotherapy in the early stage of oesophagus and gastro-oesophageal junction cancers,” says Dr Roy.

According to the current standard of care, chemoradiotherapy treatment is given to patients before surgery. As well as assessing the safety, tolerability and feasibility of the treatment, researchers want to establish primary efficacy by way of looking at the effect of immunotherapy on the tumour by analysing the tumour sample after the surgery.

“The idea for AGITG to create the Endorsed Study Model was to proactively engage with the investigators conducting pilot trials, and are sponsored by the local institutions,” says Dr Roy.

Find out more about Neo-CREATE here.



The first two patients have been enrolled in the PALEO study, led by Dr Fiona Day. PALEO is studying the effects of nivolumab and SBRT added to chemoradiotherapy in metastatic oesophageal cancer. It aims to prolong relief from dysphagia (difficulty swallowing) for patients undergoing palliative treatment for oesophageal or gastro-oesophageal cancer.

Due to an anticipated delay in multisite activation due to COVID-19, PALEO remains a single site study at Calvary Mater Newcastle, with patient recruitment now projected to extend to 2023.

“PALEO offers multimodality treatment to address the complications of oesophageal cancer,” says Dr Day. “Each of the treatment components is typically well tolerated, which fits our aim of optimising patient quality of life by aiding return to a normal diet with minimal side effects. The feasibility of this approach is demonstrated by recruitment of our first patient shortly after trial opening.”

Typically, patients with oesophageal cancer present with dysphagia. Dr Day and Prof Martin found that first line concurrent chemoradiotherapy with low dose weekly carboplatin and paclitaxel resulted in all 18 patients in a phase I study achieving improvement in their dysphagia. The majority of patients also returned to a normal diet, and at least three achieved complete relief of their dysphagia for over a year.

In the PALEO study, researchers aim to prolong this dysphagia relief and simultaneously provide disease control with the use of immunotherapy and SBRT to a metastatic site.

PALEO is open in Calvary Mater Newcastle and recruiting patients with oligometastatic oesophageal or gastro-oesophageal cancer. It was the second trial to be activated under the AGITG Endorsed Study Model.

Find out more about PALEO 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 22 patients are enrolled across Australia.

Find out 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, 426 patients have joined the study with only another 34 patients needed to complete recruitment.

Find out 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, 544 patients have joined the study, with only another 26 patients needed to complete global recruitment by the end of this year.

Learn more about TOPGEAR here.

Recent sites activated

DYNAMIC-Pancreas Toowoomba Hospital
DYNAMIC-Rectal Toowoomba Hospital
DYNAMIC-III Toowoomba Hospital
SPAR Townsville Hospital