What is a clinical trial?
Clinical trials give patients access to potentially life-saving treatments, and contribute to the development of new and improved treatments.
A clinical trial is a research study where people can volunteer to undergo new treatments, tests or use devices to help prevent, detect, treat or manage diseases or medical conditions.
Over the past few years, we have expanded our clinical trials in cancer, cardiology, stroke, diabetes, surgery services and dermatology, with a view to expand our clinical trial offering. This now means our patients won’t have to keep travelling to Melbourne to go on a clinical trial.
This growth has come from a commitment to improving health outcomes and opportunities for our community and providing more workforce opportunities in research and clinical trials.
Below is a list of the active clinical trials at LRH.
Advanced Cancer
Trial Name: FOCUSau
Open to recruitment: Yes
Principle Investigator: Dr Ahmed Nagla
About the trial: The FOCUSau study is available to people who are living with advanced cancer AND their family carers. The program is made up of four guided sessions which aim to improve the emotional wellbeing and quality of life by helping with: communication and coping strategies, planning for the future and symptom management. Participants must have internet access via a computer or tablet.
Cardiology - Heart
Trial Name: Zeus
Open to recruitment? No.
Principal investigator: A/Prof Alistair Wright
About the trial: People with cardiovascular disease and chronic kidney disease often have inflammation. If inflammation is present for a long time, it can be harmful. Long term inflammation that goes unchecked can cause heart attack and stroke. The ZEUS study will see if a certain medication can be used for people with cardiovascular disease, chronic kidney disease and inflammation to reduce their risk of having a heart attack or stroke.
Trial Name: LIBREXIA ACS
Open to recruitment? Yes
Principal investigator: Dr Derk Pol
About the trial: The research project is testing a potential new treatment in people who have had a recent heart attack to see if it reduces the risk of developing blood clots, stroke, or another heart attack. The new treatment is called milvexian.
Cerebrovascular – Stroke
Trial Name: Librexia Stroke
Open to recruitment? Yes
Principal investigator: A/Prof Alistair Wright
About the trial: This trial will look at whether an investigational drug – used in addition to normal care – is safe and beneficial in reducing the risk of future ischaemic stroke in people who have recently experienced such a stroke or trans-ischaemic attack (TIA).
Dermatology - Skin
Trial Name: Coast-1
Open to recruitment? No
Site investigator: Dr Shree Vidhya Nagendram
About the trial: Atopic dermatitis (AD), also known as atopic eczema, is a severe skin disorder that makes you itch and leaves red blotches, usually on your face, arms, and legs. AD can affect your health, social functioning, psychological wellbeing, and quality of life. This clinical trial will evaluate the effectiveness and safety of a medication hoped to restore the balance of immune cells that are active in people with moderate-to-severe AD and therefore improve symptoms. This is a teletrial with Alfred Health.
Trial Name: Estuary
Open to recruitment? No
Site investigator: Dr Tricia Wright
About the trial A follow-on study for patients who were recruited and underwent treatment on Clinical Trial ‘Coast-1’. This trial will test the effectiveness of the treatment on Coast-1 – by either continuing with the same treatment or discontinuing – using a ‘blinded’ method in selecting which patients receive which course of treatment.
Endocrinology – Diabetes
Trial Name: Best DKA
Open to recruitment? Yes
Principal investigator: Dr Pritish Korula
About the trial: Every year there are more than 7000 patients hospitalised in Australia with diabetic ketoacidosis (DKA), with an increase of 5 times the number of people admitted to hospital in the last five years. People with DKA are admitted to the Emergency Department (ED) and are treated rapidly with intravenous (IV) fluids. There are a number of fluids used, such as normal saline (0.9% Saline) and balanced multi-electrolyte (Plamsa-Lyte®148), however doctors do not know which fluid is best. Both IV fluids have been used routinely for decades in the ED and Intensive Care Unit (ICU) throughout Australia and the world. The BEST-DKA study compares these two commonly used fluids for patients hospitalised with moderate to severe DKA.
Trial Name: Flash GM
Open to recruitment? Yes
Principal investigator: Dr Sagarika Jayathilake
Associate Investigator: Dr Nay Myo Oo
About the trial: This study is Australia’s first diabetes device trial for Aboriginal and Torres Strait Islander people with type 2 diabetes. The study will assess whether using continuous flash glucose monitors (Freestyle Libre 2, Abbott) compared to standard care (finger-pricks) is helpful in improving stable sugar levels.
Haematology - Leukaemia
Trial Name: CLL-08
Principal Investigator: Dr Amanda Ormerod
About the trial:
This clinical trial is for patients suffering with Chronic Lymphoblastic Leukaemia (CLL) who have been free of the disease, but there has been a recurrence or it is worsening. This study aims to investigate if re-treatment with a previously used treatment (known as ‘VenR’) can be beneficial for the patient.
Haematology – Lymphoma
Trial name – ‘JZNX’
Open to recruitment: Yes
Principle Investigator – Dr Michael Ashby
About this trial: This Clinical Trial is for patients with relapsed or refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma (types of cancer) and have previously received treatment with a type of drug called a covalent bruton tyrosine kinase inhibitor. This research study is testing a new treatment for these types of cancer.
Haematology – Myeloma
Trial Name: FRAIL-M
Open to recruitment? Yes
Principal investigator: Dr Tricia Wright
About the trial: This trial is suitable for patients who have been diagnosed with myeloma, and the intensive therapy needed prior to stem cell transplant would not be a safe treatment option for them. There are a number of treatment options available for patients who are not eligible for transplant, but selecting the best treatment for this patient group has not been well-tested. This clinical trial is investigating which treatment combinations best suit which group of the transplant-ineligible patients who are getting older and accumulating other health problems. This is a teletrial with Alfred Health.
Trial Name: MY PROMPT-2
Open to recruitment? Yes
Principal investigator: Dr Tricia Wright
About the trial: For patients with Relapsed Multiple Myeloma (RMM), the disease and its treatments can cause adverse effects that make it difficult for them to stay on treatment. The trial will investigate if patients using a ‘real time reporting system’ of their own health, symptoms and side effects of their treatment to clinicians will improve their outcomes and ability to stay on treatment. This is a study is coordinated in partnership with Monash University.
Trial Name: RIDDLE-M-X
Open to recruitment? Yes
Principal investigator: Dr Sueh-Li-Lim
About the trial: This trial, for patients recently diagnosed with multiple myeloma (MM) and deemed eligible for autologous stem cell transplantation (ASCT – a type of bone marrow transplant), will investigate the addition of a new medication to the existing standard of care treatments. The new combination will be studied for effectiveness, safety and also how the patient feels about the treatment and their quality of life.
Trial Name: SeaLAND -MM23
Open to recruitment? No. Patients in follow up.
Principal investigator: Dr Sueh-Li-Lim
About the trial: This trial overseen by Dr Sueh-Li Lim and sponsored by the Australasian Leukaemia and Lymphoma group is a randomised trial two medications post stem cell transplant for patients with newly diagnosed multiple myeloma.
Haematology - Multiple Myeloma
Trial Name: Successor-1
Open to recruitment? Yes
Principle Investigator: Dr Sueh-Li Lim
About this trial: This is a ‘Tele-trial’ where Latrobe Regional Health works in conjunction with Alfred Health, but Gippsland patients are treated here at LRH. This trial is for patients with relapsed or refractory multiple myeloma comparing two different courses of treatment.
Oncology – Breast cancer
Trial Name: EXPERT
Open to recruitment? Yes
Principal investigator: Dr Chia May Wong
About the trial: After surgery to remove the cancer from the breast, most women are advised to have radiation therapy to the rest of the breast to lower the risk of the cancer coming back. It commonly causes short term side effects however may also have longer term negative effects for the patient. The need for radiation therapy after surgery depends on the risk of the cancer coming back in the breast. If the risk is low, there may be no need for radiation therapy. If doctors could identify women who have a low risk of the cancer coming back, these women may not need radiation therapy and could avoid its side-effects. The purpose of this study is to see whether a genomic test of breast cancer tissue can be used to select women who can safely avoid radiation therapy because there is a low risk of the cancer coming back.
Oncology – Bowel cancer
Trial Name: DYNAMIC RECTAL
Open to recruitment? Closed to recruitment – patients in follow-up
Principal investigator: Dr Sachin Joshi
About the trial: This trial is for people who have been diagnosed with colon cancer that has recently been surgically removed. The purpose of this study is to use samples of blood and the removed tumour tissue to see whether using a specific genetic test called “circulating tumour DNA” in addition to the best standard of care is a more effective way of deciding the best method of further treatment, which may include chemotherapy.
Trial Name: ALT-TRACC
Open to recruitment? Yes
Principal investigator: Dr Azim Jalali
About the trial: Metastatic colorectal cancer is typically treated with various combinations of chemotherapy medications. Once an initial chemotherapy regimen is selected, this is typically used until it stops being effective for the bowel cancer, as long as the person is tolerating treatment well. This clinical trial will evaluate the optimal combination of therapies for the treatment of metastatic bowel cancer.
Oncology – Lung
Trial Name: SPLFIO-174
Open to recruitment: Yes
Site Investigator: Evangeline Samuel
About the trial: For patients with previously untreated and advanced non-small cell lung cancer (NSCLC). This clinical trial is testing three new potential immunotherapy treatments in combination with the treatment already used and approved in Australia – Cemiplimab – to test their safety and effectiveness.
Oncology - Skin cancer - Melanoma
Trial Name: RELATIVITY-127
Open to recruitment? No. Patients in follow up.
Principal investigator: Dr Quan Tran
About the trial: This study is for patients who have unresectable (unable to be removed with surgery) or metastatic (when the cancer has spread from the place where it first formed in the body) melanoma. The study is testing a combination of drugs and investigates the best way in which the drugs can be absorbed by the body –intravenously (direct into the blood stream) or subcutaneously (under the skin).
Oncology - Prostate cancer
Trial name: DASL-HiCaP
Open to recruitment? Closed. Patients in follow up
Site investigator: Dr Bhavini Shah
About the trial: A teletrial in partnership with Alfred Health, this trial looked at a new treatment combination for localised prostate cancer in patients who received radiotherapy. This study investigated the addition of darolutamide to the existing combination therapy of radiation and oral (hormone) therapy. The trial also looked at treatment effects on the quality of life, financial costs and possible tests to better identify patients who may benefit from this treatment.
Trial name: Ironman
Open to recruitment? Yes
Site investigator: Dr Wee Loon Ong
About the trial: There are two main types of advanced prostate cancer: that which has spread and has not yet been treated with hormone therapy (metastatic hormone-sensitive prostate cancer); and that which is continuing to grow despite hormone therapy to lower testosterone levels (castration-resistant prostate cancer) and might be detectable by scans or sometimes on the basis of blood tests alone. This study will establish an international registry of people with advanced prostate cancer to learn more about the use of different treatments for these types of prostate cancer around the world; how relevant prostate cancer patients are treated and whether different patterns of treatment are associated with differences in outcomes such as the need for admission to hospital. It is also hoped the registry will help in seeing if the order and combination of treatments given have any effect on how long people survive with prostate cancer; and if subtypes of prostate cancer can be identified based on how the cancer behaves, and whether the subtypes respond differently to particular treatments or combinations.
Respiratory – Allergy (hay fever)
Trial Name: Arise
Open to recruitment? Yes
Principle Investigator: Dr Arif Kozgar
About the trial: A trial run by the Murdoch Children’s research institute, where LRH is classed as a ‘recruitment site’. This trial is for persons aged 14 to 29 who have doctor-diagnosed hay fever and have been recommended to use nasal spray for treatment. The ARISE Trial aims to find out if a specifically designed education package used alongside a daily nasal spray can help reduce symptoms and improve quality of life for young people with the condition.
Useful links:
For more information about clinical trials, visit Cancer Council Victoria’s clinical trial section https://www.cancervic.org.au/cancer-information/treatments/clinical-trials/clinical-trials-explained.html
To find out about other clinical trials, search the Australian Clinical Trials online registry https://www.australianclinicaltrials.gov.au/
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