Socrates Trial: A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage hepatocellular carcinoma (TROG 21.07 SOCRATES-HCC).
This study aims to investigate whether Stereotactic ablative body radiotherapy (SABR) is better than other current standard of care therapies for patients with a solitary HCC ≤ 8cm, ineligible for surgical resection or transplantation. The trial is conducted together with the AGITG.
Study protocol: https://pubmed.ncbi.nlm.nih.gov/38973009/
ANZCTR: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381818
Registration number: ACTRN12621001444875
Socrates Trial is coordinated by the Trans-Tasman Radiation Oncology Group (TROG Cancer Research).
Key learnings of undertaking a teletrial
TROG were assisted by the SA team of the Australian Teletrials Program (ATP) and whilst there was a steep learning curve of how to open a satellite site, it was an overall positive experience. For this trial, Royal Darwin was opened as a satellite site to Flinders Medical Centre. Radiation oncology trials naturally require that primary centres have access to the appropriate machines to deliver the treatment, but follow up visits can be at the satellite sites avoiding unnecessary travel for remote patients. The SA team specifically helped with the ethics application, Research Governance approvals, and developed the Royal Darwin Satellite Site Supervision Plan. These learnings will help future trials to be managed this way.
Future plans
TROG are hoping to do more trials using the teletrial/ decentralised clinical trials methodology for follow up. They are also keen to credential more regional centres delivering radiation treatments. To date, they have credentialed Warrnambool, and ICON Cancer Care are keen to credential more of their regional centres. There is a very high cost for credentialing, but this investment should yield a positive return on investment.
Learnings
TROG have identified that the requirements for teletrials have to be built into funding applications from the outset. At the current time, conducting teletrials is a more costly option, but there is hope that this will change. As a coordinating network, TROG would like guidance on what to put in the protocol to support inclusion of the teletrial model, as well as more clarity over how to word the consent materials. The teletrial model will not be possible where patients have to travel for multiple fractions of treatment, but credentialing regional centres will assist with reducing the burden involved of patients having to come to metro sites.
This case is part of ACTA’s teletrials web resource which includes more examples of how Clinical Trial Networks (CTNs) and Coordinating Trial Centres (CTCs) have used the teletrial approach in their trials.
Find out more
Please contact the TROG team:
Angie Chung
E: SOCRATES_HCC@trog.com.au