Clinical trials

We're providing more treatment opportunities for Gippsland people.

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.

Cardiology - Heart

Trial Name: Zeus

Open to recruitment? Yes

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.

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? Yes

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.

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.

Haematology - Leukaemia

Trial Name: OTSUKA

Open to recruitment? Yes

Principal investigator: Dr Michael Ashby

About the trial: This clinical trial is for patients suffering with either Myelodysplastic Syndrome (MDS), Acute Myeloid Leukaemia (AML) or Chronic Myelomonocytic Leukaemia (CMML). The purpose of this study is to understand participant preference for mode of administration of treatment. Currently, it is assumed more patients will prefer an oral treatment (taken by mouth) over a subcutaneous injection (an injection under the skin), however, this has not been formally studied in a controlled setting. The information obtained from this study may help towards understanding how patients would like to be treated for their condition and the main reasons why they prefer one treatment to another. This may allow doctors in the future to provide care for blood cancer patients that is more suitable to their needs.

Haematology - Lymphoma

Trial Name: BGB -311-08

Open to recruitment? Yes

Principal investigator: Dr Amanda Omerod

About the trial: This clinical trial is for patients who have been diagnosed with follicular lymphoma (FL) or marginal zone lymphoma (MZL) and whose lymphoma has not gotten better with recent treatment (refractory) or did get better but has returned (relapsed). The trial is testing if a new medication given in combination with existing treatments can help to control the disease and increase the length of complete remission or partial remission compared to a commonly used treatment combination. The study will not only compare effectiveness, but also safety, tolerability, and quality of life between the investigational treatment and the commonly used treatment.

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? Yes

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.

Trial Name: PRO-DVD

Open to recruitment? Closed to recruitment – patients in follow up

Site investigator: Dr Amanda Omerod

About the trial: For those with relapsed multiple myeloma, this trial looks at the tolerability of the treatment regime, the type and severity of perceived side effects, overall patient experience of the treatment and the impact of this particular ‘DVD’ treatment on the quality of life of patients through completion of various questionnaires. This information could assist in improving the care and outcomes for patients with relapsed multiple myeloma.

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.

Trial Name: CAPTURE

Open to recruitment? Yes

Principal investigator: Dr Mahesh Iddawala

About the trial: As a cancer grows, cancer cells die and are replaced by new ones. The dead cells get broken down and their contents, including DNA, are released into the bloodstream. This type of DNA is called circulating tumour DNA (ctDNA). Looking at a specific type of advanced breast cancer, this trial will look at using ctDNA to identify a particular mutation in a gene that helps these cancer cells grow and work out if a certain medication might be most effective.

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 cancer

Trial Name: ORIGAMA

Open to recruitment? Yes

Principal investigator: Dr Hieu Chau

About the trial: The purpose of this trial is to find out whether the use of a digital patient monitoring software system or ‘app’ impacts health, symptoms, and quality of life in people with lung cancer (metastatic non-small cell lung carcinoma (mNSCLC)) or (extensive-stage small-cell lung carcinoma (ES-SCLC) who are being treated with a specific type of cancer medication. The ‘app’ is intended to allow these patients to report their symptoms and quality of life to their care team; receive reminders and instructions related to their symptoms; obtain information related to their disease and treatment and send non-urgent messages to their care team.

Oncology - Skin cancer - Melanoma

Trial Name: RELATIVITY-127

Open to recruitment? Yes

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: GUIDE

Open to recruitment? Yes

Principal investigator: Dr Hieu Chau

About the trial: The purpose of this clinical trial is to see if a prostate cancer marker in the blood (mGSTP1) can be used to guide chemotherapy treatment. Based on the level of this blood marker, some men may be able to have breaks in treatment rather than having chemotherapy continuously which is the current standard of care. This trial will tell us if having these treatment breaks guided by mGSTP1 can improve how men feel during treatment while still treating the prostate cancer effectively.

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.

 

Oncology - Genomic profiling

Trial Name: Cancer Statewide/iPREDICT-2

Open to recruitment? Yes

Principal investigator: Dr. Sachin Joshi

About the trial: Genes contain information for the cells of the body to function in the form of a “code” that the cell “reads”. Each gene has a specific function. Some genes are involved in making sure the cell grows and divides normally, however cancers are caused by gene changes (“errors in the code”), causing abnormal cell growth. Sometimes these gene changes are found to be inherited and cause individuals to be predisposed to developing cancer. For some patients, drug treatments exist which are aimed at specific gene changes. Complex genomic profiling – via a blood test – can be used to identify variations in a cancer to determine whether there are drug treatments that would target the cancer. This could change the diagnosis and management of patients with advanced cancer.

Rheumatology - Arthritis

Trial Name: SOLAREA

Open to recruitment? Yes

Principal investigator: Dr Anthony Boers

About the trial: Rheumatoid arthritis (RA) is a chronic autoimmune disorder that leads to pain and swelling of the joints, ultimately leading to loss of joint function. Patients with new-onset RA or at risk for RA progression have been shown to have an imbalance in the microbes (organisms that are too small to see with the naked eye) found in the gut. Clinical trials examining the effects of probiotics in patients with RA have shown promising results with reports of decreased self-assessed pain, disability and decreased disease activity, indicating that solutions that target the microbes in the gut may be a possible solution for patients with RA. This clinical trial will look at the effects of taking pre- and pro-biotics, in addition to standard of care treatments, in patients with early-onset RA.

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