AGITG News: January-June 2020

Our trials during COVID-19

While many of us have been working from home, there has certainly been a lot of work to do in light of the pandemic. The impact of the COVID-19 pandemic on the AGITG-CTC (NHMRC Clinical Trials Centre) trials portfolio is being reviewed on an ongoing basis as this unprecedented situation evolves.

A number of measures have been undertaken in conjunction with the relevant Trial Management or Executive Committees for the eight trials currently open to recruitment or in follow up. Guidance documents have been created and circulated to provide individual trial management support for sites and serve as a guide for trial logistics and procedural adjustments to preserve the safety of participants.

Final patient joins the MODULATE trial

The final patient participating in the MODULATE clinical trial joined in May, meaning that all 90 participants are enrolled in the study.

MODULATE, led by Professor Niall Tebbutt, is a phase II clinical trial evaluating a new combination treatment for ‘microsatellite stable’ colorectal cancer, which makes up about 80-85% of colorectal cancers. These cancers do not respond to immunotherapy, treatment that triggers the immune system to attack cancer, because the tumours exist in an environment that suppresses the immune system.

“One of the more promising treatments in oncology in general at the moment is immunotherapy,” Professor Tebbutt says. “That plays a role in lots of other cancers, but generally bowel cancer is resistant.”

Participants in MODULATE are treated with nivolumab, a form of immunotherapy known as a ‘PD1 inhibitor’. Some cancer cells have high levels of the protein PD1, which plays a role in helping them to hide from the immune system. Nivolumab inhibits the effect of PD1, meaning that the immune system can recognise and attack cancers. In addition, participants also received one of two other drugs, believed to facilitate white blood cells in reaching cancers.

Professor Tebbutt says, “If we could learn something from MODULATE that could enable us to design a better study down the track, it would be worthwhile.”

The safety and well-being of our participants, other patients, family members, researchers and other clinical and support staff is paramount. Therefore, several measures have been implemented to minimise participant exposure to COVID-19, including reduced clinic visits through use of telehealth where possible.

CONTROL NETS presented at ASCO

Associate Professor Nick Pavlakis presented the initial results of CONTROL NETS at the American Society of Clinical Oncology (ASCO) Annual Meeting in May.

CONTROL NETs is investigating whether chemotherapy, radiopeptide therapy or a combination of both is the most promising treatment for improving disease control in patients with advanced NETs. The study has recruited 75 patients with pancreatic or small bowel NETs. Patients were randomised to receive either capecitabine (chemotherapy)/LuTate (radiopeptide), just capecitabine, or just LuTate.

The initial results of the trial were also presented at the ASCO GI meeting in January.

Associate Professor Pavlakis says, “The study is hoped to lead to significant learnings to assist the future treatment of patients with neuroendocrine tumours.I l ook forward to sharing the final results of the trial in the future.”

The trial participants are currently in follow-up.

Learn more about CONTROL NETS here.

MASTERPLAN trial recruits first patient

The first patient joined the MASTERPLAN trial in February this year. MASTERPLAN is a phase II randomised study of mFOLFIRINOX and sterotactic body radiotherapy (SBRT) for patients with high risk, borderline resectable or locally advanced pancreatic cancer. The study has also opened at sites across Australia including Royal Adelaide Hospital, the Chris O’Brien Lifehouse in Sydney, Peter McCallum Cancer Centre in Melbourne, and Icon Cancer in the Gold Coast.

The study first opened in Princess Alexandra Hospital, Brisbane, in October 2019. It aims to determine if adding SBRT to mFOLFIRINOX improves cancer control rates in and around the pancreas.

SBRT allows a significant dose escalation compared to standard external beam radiotherapy (EBRT) without an increase in toxicity. This is hoped to increase tumour cell deathand reduce rates of locoregional recurrence.

The guidelines for pancreatic SBRT, developed by the MASTERPLAN study team, have been published in Elsevier Practical Radiation Oncology. View the guidelines here.

The enrolment target for the study is 120 patients. Learn more about MASTERPLAN here.

MONARCC presented at ASCO GI

The MONARCC trial was presented at the ASCO GI Posters in Progress Session in January by Dr Matthew Burge, Study Chair of the trial.

In the trial, researchers are studying the potential of using a ‘lighter’ chemotherapy regimen, 5 flurouracil, together with the antibody treatment panitumumab. They will also test the effectiveness of using panitumumab by itself. These options could provide effective cancer control while minimising side effects.

Dr Burge, believes that it will be instrumental in providing “a treatment option for elderly patients that is well-tolerated, that’s convenient, and that provides them with the best outcomes in terms of survival and quality of life”.

Learn more about MONARCC here.