South West Healthcare has a dedicated webpage for patients, with more information about taking part in clinical trials, and what is currently enrolling locally.
If you are a patient, or just want to know more about clinical trials, please visit – Clinical Trials | South West Healthcare.
The CTU offers its services in cancer and non-cancer clinical trials, and supports their facilitation using various models of delivery, including tele-trials.
For Industry Representatives and Healthcare Professionals who wish to engage the CTU services, please contact us for further information on (03) 5563 1229.
Additional information can be found on the following:
Referrals directly to the CTU can be made either by email clinicaltrials@swh.net.au or phone (03) 5563 1407.
The CTU works closely with our investigators and provides essential support in the conduct of each clinical trial. For new or potential investigators, here you will find key information relating to the conduct of clinical trials. If you wish to engage the CTU to conduct a clinical trial, or would simply like to know more, please contact us for further information on (03) 5563 1229.
Good Clinical Practice certification is mandatory for all clinical trial personnel. Its primary goal is to ensure the safety and rights of trial participants and the credibility of trial data, facilitating mutual acceptance of trial results by regulatory authorities worldwide.
Certification can be obtained by completing a short, online course here – ICH Good Clinical Practice Certification Training
For comprehensive clinical trial education, the Australian Clinical Trials Education Centre (A-CTEC) provides free access to a suite of courses.
To view what is available, please visit Australian Clinical Trials Education Centre (A-CTEC) – Melbourne Academic Centre for Health
The SWH Research Office provides helpful resources and information relating to the conduct of clinical trials, and can be found here Essential Documents and Resources for conducting research at South West Healthcare
Below is a list of clinical trials conducted by the SWH CTU that are open for enrolment. For more information on any of these, please contact the SWH CTU on (03) 5563 1407.
Title: Alternating oxaliplatin and irinotecan doublet schedules versus continuous doublet chemotherapy in previously untreated metastatic colorectal cancer: A Treatment of Recurrent and Advanced Colorectal Cancer registry-based prospective randomised trial (ALT-TRACC)
Trial Summary: To determine the efficacy of alternating oxaliplatin and irinotecan doublet chemotherapy +/- clinician’s choice biologic agent vs continuous doublet chemotherapy +/- clinician’s choice biologic agent in treatment for metastatic colorectal cancer treatment by reporting progression free survival on first line chemotherapy (PFS)
More Information: ANZCTR – Registration
Title: Bone Loss Prevention with Zoledronic Acid or DeNosumab in Critically Ill Adults – A Randomised Controlled Trial
Trial summary: A prospective, randomised, controlled, trial comparing denosumab (60mg subcutaneous (sc) 6-monthly) or zoledronic acid (5mg intravenous (IV) single dose) to placebo
Women aged 50-years or older and men aged 70-years or older requiring admission to intensive care for more than two calendar days
Compare the effect of subcutaneous denosumab or intravenous zoledronic acid to placebo on change in bone mineral density over one year in women aged 50-years or older and men aged 70 years or older requiring admission to intensive care for greater than 2 calendar days.
More Information: ANZCTR – Registration
Title: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
More Information: ANZCTR – Registration
Title: FAPI-CUP – Evaluating FAPI as a novel radiopharmaceutical targeting cancer-associated fibroblasts for the diagnosis of patients with Cancer of Unknown Primary
Trial summary: This is a prospective single arm cohort study designed to evaluate the diagnostic ability of 68Ga-FAPI-PET/CT scan in determining likely tissue of origin in Cancer of Unknown Primary (CUP) patients not identified by standard of care. Patients with CUP will be either treatment naïve or starting second-line treatment.
Detailed Description: Cancers of unknown primary (CUP) account for 3-5% of all malignancies. The prognosis of patients diagnosed with CUP is poor, with a median overall survival of 9-12 months. Despite improvements in conventional diagnostic processes, the tissue of origin (ToO) is identified in <30% of CUP patients. PET/CT is increasingly used to determine the ToO, with the most commonly used PET radiotracer being the glucose analogue fluorine-18 fluorodeoxyglucose (FDG). Although PET/CT can change CUP patient management and identify primary sites, FDG has limited sensitivity for detecting some
cancers, such as CUP. It has been reported that fibroblast activation protein (FAP) is highly expressed in some tumours, including CUP. 68Ga-FAPI (experimental drug) is a radiotracer that can specifically bind to FAP, and may enable the primary cancer site to be viewed using PET imaging. It is hypothesised that the use of 68Ga-FAPI-PET/CT will increase likely ToO diagnosis from 30% with current standard of care to 60%.
More Information: ANZCTR – Registration
Title: Evaluating the impact of interventions to reduce frailty in mildly frail older adults in Australia – a randomised type 1 comparative effectiveness-implementation study
Trial summary: The FITTEST study is an Australia-wide, parallel, 2-arm superiority, individually randomised, type 1 comparative effectiveness-implementation trial. A hybrid type 1 design has been chosen to allow us to test the effectiveness of two different ways to deliver a multicomponent frailty intervention while concurrently exploring the ‘implementability’ of these intervention. This will allow us to understand how the intervention may (or may not) work in the real world and generate theory about mechanisms of impact, whilst achieving the trial’s primary aim to compare the effectiveness of two interventions – one supervised and one self-directed – to reduce frailty in mildly frail older adults.
More Information: ANZCTR – Registration
Title: Pharmacogenomic medicines optimisation for people with cancer – a multicentre teletrial enabled Interrupted Time Series trial
Trial summary: Multi-centre prospective tele-trial enabled interrupted time series (ITS) trial
Time Series 1 (control): Standard of care (SOC) prescribing for medications
Time Series 2 (intervention): Pharmacogenomics (PGx) prescribing for medications
Eligible patients with unresectable or metastatic colorectal cancer in Time Series 1 and 2 can receive 5-FU TDM-guided prescribing
Participants will be recruited based on their cancer diagnosis and anticancer treatment they are receiving – selected based on likelihood of receiving medicines with established or emerging evidence for pharmacogenomics.
More information – ANZCTR Registration
Title: A prospective observational study of palliative care and cancer symptom management interventions – understanding the burden of the adverse effects.
Summary: This is a quality improvement program rather than a clinical trial.
The Rapid Program is an international, multi-site, consecutive cohort, post-marketing study of the real-world net clinical effects (benefits and harms) of medications and nonpharmacological interventions used in hospice/palliative care.
Rapid Program methodology uses active surveillance that collects, analyses and provides data on widespread and longer-term use of medications or non-pharmacological interventions captured from the time of prescribing using pro-formas. Each medicine or intervention is referred to as a series. The program includes a medicine/intervention series across a number of symptom areas commonly experienced in palliative care and cancer symptom management including: pain, breathlessness, gut dysfunction, nausea, mood and cognitive and neurological disorders, appetite and cachexia, fatigue and sleep.
The Rapid Program uses minimal resources, is timely, involves prescribers from around the globe, and publishes each series to add to the knowledge for clinical prescribing and use of non-pharmacological therapies that are commonplace in palliative care and cancer symptom management practice.
The evidence collected from these studies directly informs clinical practice.
More Information: IMPACCT Rapid Program | University of Technology Sydney
Title: Solving Unknown Primary cancER Earlier Diagnosis (SUPER-ED): A stepped wedge cluster randomised controlled trial implementing a Model of Care to support earlier diagnosis
Trial summary: SUPER-ED is a pragmatic stepped-wedge cluster randomised trial comparing a control phase of standard practice with an intervention phase. The steppedwedge trial design features clusters which cross from a control to intervention at staggered time points, with all clusters ending with exposure to the intervention. This trial consists of a control phase for each site followed by a crossover point of one month before the intervention commences.
More Information: ANZCTR – Registration
The below are a list of trials being run outside of the clinical trials unit.
Scientific title: Is rectus abdominis training, or transversus abdominis training, or natural recovery, more effective for reducing the inter-recti distance in women with Diastasis of the Rectus Abdominis Muscles during the early postpartum period? A randomized controlled trial.
Trial Summary: A single-centre, parallel-group, longitudinal randomised controlled trial recruiting participants who have given birth via any method within the past 72 hours who have diastasis of the rectus abdominis muscle (DRAM) with a separation of >28mm at the level of the umbilicus. It will involve three groups:
More Information: ANZCTR Registration
ASPREE (ASPirin in Reducing Events in the Elderly) is a joint US/Australian research project aiming to determine whether low-dose aspirin increases healthy life-span, defined as survival free of dementia and disability. ASPREE began in 2010 and completed recruitment in 2014. It is a randomized, double-blind, placebo-controlled, primary prevention trial of daily 100 mg of aspirin in a population of healthy older people in the United States (US) and Australia with a period of treatment averaging 4.5 years. ASPREE’s primary outcome is length of survival free of dementia and disability and has secondary outcomes encompassing the major health issues related to aging. The trial involving 19,114 persons aged 70 and above (65 years and above for US minorities) is distinctive for its large size, methodological rigor and high participant retention rate in both countries.
ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants. An observational follow-up phase (ASPREE-XT), began in January, 2018. This will enable the monitoring of possible delayed effects of aspirin treatment, primarily on cancer incidence, metastases and mortality.
Trial summary:
Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions, exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults.
Trial Summary:
The aim of the study is to investigate the frequency, type and consequences of injuries for females who present to an emergency department of urgent care centre in Geelong or South West Victoria.
Study one will collect information regarding the types of injuries sustained by females and compare this information to males. Information will be extracted from participants’ medical records.
Study two will collect information regarding the consequences of injuries sustained by females. Information will include healthcare treatments, time off work or school and time away from playing football. Information will be collected via questionnaires sent to participants 6-10 weeks following injury.
Trial Summary:
We are testing a different method of receiving the patient outcomes survey for our national stroke registry. The Australian Stroke Clinical Registry traditionally collects outcomes data between 90-180days after stroke using a paper-based survey that is mailed to the registrant. If registrant does not respond after two attempts by mail, we telephone them to complete the survey. Use of short-message-service (SMS) with an electronic link to the survey form that is sent to the registrant’s mobile phone number may be a more feasible and cost-effective approach to receiving the outcome survey data from registrants.
We hypothesise that, compared to our traditional methods, those receiving an SMS will have greater response rates and more timely completion of the outcomes survey with less missing data, and that this new method will reduce costs for collecting these data.
A process evaluation to determine why some patients might choose to complete the follow-up questionnaire via the SMS method, while others do not, will also be undertaken.
The outcome of this project is to provide evidence on whether the option of electronic collection of outcome data via SMS should be incorporated as part of our usual registry processes.