A FOCUS ON INVESTIGATOR INITIATED TRIALS

Icon’s Investigator Initiated Trials (IIT) team was established early in 2021 and is responsible for the development and management of the IIT portfolio. The IIT team are experienced in all aspects of study development from concept initiation and protocol development through to publication. This work is supported and sponsored by Icon Cancer Foundation.

In 2022 Icon made significant leaps forward in the IIT portfolio and capacity. With the execution and publication of the Icon IIT Framework, two new trials opened to recruitment, and a focus on developing collaborative partnerships, the year saw record recruitment numbers and further interest in the development of IIT strategic growth.

2023 and beyond will see expansion of Icon’s IIT capacity to increase efficiencies of current IITs and support new initiatives. This will include expansion into all areas of cancerous and non-cancerous conditions as well as pharmacy studies, theranostics, medical oncology and haematology trials aimed at improving patient treatments and outcomes. In 2023 the team also aims to activate the first randomised control trial under the new Icon IIT Framework and expand trials into a multicentre model.

The following outlines our significant IIT achievements of last year including a milestone partnership, trial snapshots and a major publication.

Varian Research Framework Agreement

Varian and Icon Group have entered a global five-year strategic partnership, which includes the development of ongoing clinical and technical research programs to advance cancer care.

The collaboration allows for the development and execution of a number of radiation medicine studies supported by Varian which will meet the strategic direction of both organisations and improve radiation oncology technologies.

In 2023, the two organisations will continue the commencement of work on three new research projects under this agreement and focus on evolutions in radiation software, treatments and techniques.

Tremor Trial Hyperarc Registry

Icon became the first international participant in the Varian-initiated HyperArc® Registry. HyperArc is an end-to-end treatment workflow which allows patients to receive radiotherapy to multiple brain tumours in a safe and streamlined manner.

The HyperArc registry has been initially opened at three Icon Cancer Centre locations across Australia (Gold Coast, Maroochydore and Greenslopes) and is coordinated centrally by the IIT team, while being supported locally by radiation oncologists, radiation therapists and medical physicists.

Data collected in the registry will be used to gain a real-world understanding of outcomes following HyperArc treatment. The HyperArc registry will be opened at further Icon Cancer Centre locations across the Australian Icon network in 2023, with ambitions to also implement the registry at international locations.

Liberate Registry

Dr Andrew See and A/Prof Jeremy Grummet are co-investigators of LIBERATE which is the only clinical registry monitoring patients who have undergone focal brachytherapy in Australia. As part of the LIBERATE clinical registry, focal brachytherapy treatment is now available at Icon Cancer Centre Geelong, Icon Cancer Centre Richmond and Icon Cancer Centre Freemasons.

Focal brachytherapy is a highly-targeted technique which involves the implantation of small radioactive seeds directly into the cancerous area of the prostate. Icon’s LIBERATE clinical registry, which was launched in 2019, monitors men who have undergone focal brachytherapy for low to intermediate risk prostate cancer at Icon Cancer Centre in collaboration with Epworth Healthcare. The registry will collect data for 5 years following treatment to determine the effects of treatment on long term quality of life and rates of cancer control.

Funding for the LIBERATE clinical registry was provided by the Epworth Medical Foundation, Icon Cancer Foundation and supported in kind by Icon Cancer Centre.

The TREMOR clinical trial represents strategic expansion of Icon’s radiation medicine IIT portfolio into benign (non-cancerous) conditions. TREMOR brings together a multidisciplinary team led by Principal Investigator, Radiation Oncologist, Dr Kevin So, involving external collaborators in the field of neurology and neurosurgery. Funding for the TREMOR clinical trial was provided by the Epworth Medical Foundation, Icon Cancer Foundation and supported in kind by Icon Cancer Centre. The trial aims to evaluate the effectiveness of advanced stereotactic radiosurgery (SRS) for the treatment of essential or Parkinson’s related tremor.

Conventional treatment for tremor within the clinical trial setting involves deep brain stimulation, an invasive surgical procedure that places electrodes or needles into the central part of the brain and a stimulator into the chest wall.

Stereotactic radiosurgery is non-invasive and involves a highly targeted form of radiation treatment that delivers high doses of radiation while sparing the surrounding tissue and organs and has been used for many decades to treat benign (non-cancerous) and cancerous brain conditions.

Dr Kevin So says the advanced treatment offers new hope for people afflicted with tremor who face limited treatment options.

TREMOR is a welcome and exciting clinical trial for the many Australians and people across the world impacted by essential tremor and Parkinson’s disease. These conditions can be devastating for patients who may no longer be able to perform the simple tasks we often take for granted, such as feeding ourselves and brushing our teeth, especially when they are unable to receive conventional treatment. Our hope is that this research will support the thousands of Australians who develop tremor to access advanced, non-invasive radiation treatment which improves their quality of life.”

- Dr Kevin So

PROSPER-82 PUBLICATION

The results of the ProSPER-82 trial, led by Radiation Oncologist Dr Andrew See, were published in 2022 in the journal Radiation Oncology. The ProSPER-82 trial, involving 70 men with localised prostate cancer, was the first to investigate the combination of very-high dose radiation therapy (up to 82 Gy) and the use of a protective gel spacer placed between the prostate and the rectum (back-passage).

Without the use of a gel spacer, up to one in five men may experience significant changes to their bowel function due to radiation therapy, such as bleeding or pain. In the ProSPER-82 study, no significant long-term side effects were observed up to three years following treatment and participants reported that their quality of life was maintained. In addition, cancer control was achieved in 90% of men, demonstrating that this approach is both safe and effective.

Funding for the ProSPER-82 clinical trial was provided by the Epworth Medical Foundation, Icon Cancer Foundation and supported in kind by Icon Cancer Centre.

Published on 25 July 2022 in the journal Radiation Oncology

Icon and Varian signed a

Highest recruitment to date

Activation of the TREMOR trial