A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HepatoCellular Carcinoma (SOCRATES HCC).

BACKGROUND: Therapeutic options for early-stage hepatocellular carcinoma (HCC) in individual patients can be limited by tumor and location, liver dysfunction and comorbidities. Many patients with early-stage HCC do not receive curative-intent therapies. Stereotactic ablative body radiotherapy (SABR) has emerged as an effective, non-invasive HCC treatment option, however, randomized evidence for SABR in the first line setting is lacking. METHODS: Trans-Tasman Radiation Oncology Group (TROG) 21.07 SOCRATES-HCC is a phase II, prospective, randomised trial comparing SABR to other current standard of care therapies for patients with a solitary HCC ≤ 8 cm, ineligible for surgical resection or transplantation. The study is divided into 2 cohorts. Cohort 1 will compromise 118 patients with tumors ≤ 3 cm eligible for thermal ablation randomly assigned (1:1 ratio) to thermal ablation or SABR. Cohort 2 will comprise 100 patients with tumors > 3 cm up to 8 cm in size, or tumors ≤ 3 cm ineligible for thermal ablation, randomly assigned (1:1 ratio) to SABR or best other standard of care therapy including transarterial therapies. The primary objective is to determine whether SABR results in superior freedom from local progression (FFLP) at 2 years compared to thermal ablation in cohort 1 and compared to best standard of care therapy in cohort 2. Secondary endpoints include progression free survival, overall survival, adverse events, patient reported outcomes and health economic analyses. DISCUSSION: The SOCRATES-HCC study will provide the first randomized, multicentre evaluation of the efficacy, safety and cost effectiveness of SABR versus other standard of care therapies in the first line treatment of unresectable, early-stage HCC. It is a broad, multicentre collaboration between hepatology, interventional radiology and radiation oncology groups around Australia, coordinated by TROG Cancer Research. TRIAL REGISTRATION: anzctr.org.au, ACTRN12621001444875, registered 21 October 2021.

Community engagement in Health Technology Assessment and beyond: from guests in the process to hosts.

In Health Technology Assessment (HTA), clinical and economic evidence are assessed in the regulatory and reimbursement environments, with community input considered as complementary to this. Stakeholders are calling for more meaningful community engagement, but this will not be reached without a significant shift. The Centre for Community-Driven Research (CCDR) is a nonprofit organization bringing much needed change to the way we think about community engagement in health. This article is based on CCDR's experience and outlines three system changes needed to advance community engagement in decisions about health and HTA. This paper comes from the perspective of engaging everyday people in the process as opposed to representation on panels and committees. The three key areas of change that are discussed include building holistic evidence, creating supportive environments, and infrastructure for community engagement, with the term community referring to people affected by disease or health conditions and their carers/families.

Experience and Expectations of Ovarian Cancer Patients in Australia.

Some of the most significant advances in ovarian cancer treatment have been those that result in improvements in progression-free survival (PFS); however there is little research to understand the value that patients place on accessing therapies that result in PFS as a clinical outcome related to survivorship. This study therefore aimed to understand the experience and expectations of women with ovarian cancer in Australia in relation to quality of life (QoL) and treatment options. An online survey collected demographic information and 13 investigator-derived structured interview questions were developed to understand the experience of women with ovarian cancer, their understanding of terminology associated with their condition, and expectations of future treatment. This study demonstrated that ovarian cancer patients equate PFS with being in remission and that patients expect QoL during that time to be good to excellent. Women in this study described excellent QoL as feeling positive and happy and not worrying about cancer, feeling fit and healthy without side effects, and being able to live life as they did before their diagnosis, including the absence of fear of progression or recurrence. It is therefore suggested that there is a positive relationship between PFS and QoL. While it is difficult to quantify QoL and further research is needed, the results of this study suggest that the minimum time that women with ovarian cancer expect in relation to treatments that result in PFS is approximately six months. In the absence of this information, decision-makers are left to make assumptions about the value women place on access to therapeutics that increase PFS, which for this type of cancer is an important aspect of survivorship.

A Snapshot of Community Engagement in Research in the Context of an Evolving Public Health Paradigm: Review.

BACKGROUND: Community engagement is a work in process. Researchers continue to refine the process of collaboration and look to best practice and lessons learned for guidance in this relatively new model. OBJECTIVE: The aim of this study was to provide a snapshot of whether community engagement has been included in the design and implementation of research initiatives in Australia, Canada and the United Kingdom. The secondary aim is to identify the underlying themes present, to identify theories and tools that drive research. METHODS: A literature search was performed to identify studies that have been conducted to reduce the weight of the general population. RESULTS: The results of the study, which focused on the field of weight loss, indicate that scientific and technological advancements are the primary drivers of research. However, these new research initiatives have largely been undertaken in the absence of community engagement. CONCLUSIONS: The study concludes that initiatives need to adapt to a wider range of stakeholders, develop equitable community engagement platforms and take into consideration.

Identifying and prioritising gaps in colorectal cancer trials research in Australia.

OBJECTIVES: To identify gaps in colorectal cancer clinical trials research in Australia and to suggest and prioritise trials to fill those gaps. DESIGN, SETTING AND PARTICIPANTS: Retrospective review of colorectal cancer trial activity from 1 January 2005 to 1 July 2011 in Australia and internationally, followed by a consensus meeting of consumers, health care professionals, researchers and funding agencies. MAIN OUTCOME MEASURES: Proportion of Phase III and randomised clinical trials in the areas of prevention, screening, surgery, adjuvant therapy, advanced disease and behavioural interventions, and priority areas of research identified by participants at the consensus meeting. RESULTS: The registry search identified 76 colorectal cancer clinical trials (all phases) registered in Australia from 1 January 2005 to 1 July 2011, of which 51 were Phase III or randomised, and 323 Phase III and randomised trials registered worldwide. In Australia, most trials were in advanced colorectal cancer (32), screening (10), and behavioural interventions (9). Worldwide, most Phase III or randomised trials were in advanced disease (94, 29.1%), surgery (64, 19.8%), behavioural interventions (38, 11.8%), and screening (30, 9.3%). At the consensus meeting, all participant groups emphasised the need for research in secondary prevention, screening, individualised treatments and follow-up care after treatment for colorectal cancer. CONCLUSIONS: There is a mismatch between the high proportion of registered trials in advanced colorectal cancer and the areas of priority identified. The development of specific trials in these priority areas depends on the availability of funding and the existence of plausible interventions likely to improve patient outcomes.