Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions.
A trial is a documented, and ethically approved process to compare one treatment with another to determine the best treatment.
Most clinical trials involve treatment, such as surgery, chemotherapy or radiation. Understanding the safety issues associated with the new treatment is key.
There are some studies which do not involve drugs or new treatments. These non-treatment trials may look at population-based or demographic information, looking for patterns or clues to causation of disease. Some look at quality of life issues or the role of supportive care in oncology services.
If you are offered participation in a clinical trial, you need to know that it is always your choice to be involved. You also need to know the alternatives to participation.
Your decision should be based on complete details about the trial including its aim, how it is being conducted, your responsibilities as a participant, and any potential risks or benefits to you.
This information will be made available to you along with a consent form. You should have adequate time to read and understand the information, and the opportunity to ask any questions about the trial with the investigator.
You can withdraw at any time without penalty. All clinical trials are reviewed, approved and overseen by an ethics committee.
New interventions that help people to live longer, have less pain or be free of disability are only possible because of the willingness of people to participate in clinical trials. Both healthy participants and those diagnosed with a disease or condition are needed to help find new ways to diagnose, prevent, treat or cure disease and disability. If more people are involved in clinical trials, it may reduce the time it takes to make new interventions widely available.
By taking part in a clinical trial, you can contribute to the advancement of scientific knowledge and, in some cases, to improved health for yourself or others with the same disease or condition.
Everyone taking part in a clinical trial must give ‘informed consent’, or have a parent or guardian or other legally authorised person give consent.
Informed consent means that potential participants are given information about the key facts of a clinical trial before deciding whether or not to take part. Informed consent also means that participants are provided with information on new developments throughout the trial.
You cannot be entered into a trial if you don’t want to be. If you are asked to take part, you are free to say yes or no at any time. There should be no pressure on you to enter a trial. If you are under 18, a parent or guardian has to give legal consent and you have to give your permission as well.
To help you decide whether or not to be part of a trial, members of the research team will explain the details of the trial to you. The researchers will also provide a document, usually called a participant information and consent form, which includes details about the study such as its purpose, duration, required procedures, risks and potential benefits. You can ask about anything that is not clear to you or that you do not understand. You can take your time and talk it over with family and friends or your own doctor before deciding whether to take part.
You will then decide whether or not to sign the consent document. Signing the consent document means that you are agreeing to take part in the trial and have understood what that will involve.
The consent document is not a contract, and you may withdraw from the trial at any time. If you do withdraw from a clinical trial, the relationship between you and your doctor will not be affected.
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)
Title: A phase II randomised study to evaluate alpelisib plus fulvestrant versus capecitabine in estrogen receptor positive, HER2-negative advanced breast cancer patients with PIK3CA mutant circulating DNA.
Trial Summary: The purpose of this study is to determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival (PFS) compared to capecitabine in patients with oestrogen receptor positive (ER+), HER2-negative advanced breast cancer (ABC) who have PIK3CA mutant circulating DNA and have received prior treatment with a CDK4/6 inhibitor (CDK4/6i) and aromatase inhibitor (AI).
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%.
Title: A Study to Compare the Efficacy and Safety of Golcadomide Plus R-CHOP vs Placebo Plus RCHOP in Participants with Previously Untreated High-risk Large B-cell Lymphoma
Trial Summary: The study is designed as a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to compare the efficacy and safety of Golcadomide plus R-CHOP vs placebo plus RCHOP in participants with previously untreated high-risk large B-cell lymphoma. Approximately 850 participants will be randomized at a 1:1 ratio to either Golcadomide plus R-CHOP or placebo plus R-CHOP. The study will consist of 3 consecutive periods: screening period, study treatment period and post-treatment follow-up period. Study participation for each participant will include a screening period of up to 28 days (4 weeks) followed by 6 cycles (18 weeks) of either Golcadomide plus R-CHOP or 6 cycles (18 weeks) of placebo plus R-CHOP in the study treatment period. Subsequently, all participants will move into the post-treatment follow-up period.
Title: LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC
Trial Summary: The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.
Title – A Phase III, Randomized, Open-Label Study Evaluating Efficacy And Safety Of Giredestrant Compared With Fulvestrant, Both Combined With A Cdk4/6 Inhibitor, In Patients With Estrogen Receptor-Positive, Her2-Negative Advanced Breast Cancer With Resistance To Prior Adjuvant Endocrine Therapy
Trial Summary – This Phase III study is designed to demonstrate a statistically significant and clinically meaningful progression-free survival (PFS) benefit of giredestrant compared with fulvestrant, each combined with the investigator’s choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) between palbociclib, abemaciclib and ribociclib, as first-line (1L) treatment of estrogen receptor-positive (ER+), HER2-negative (HER2-) advanced breast cancer (ABC) resistant to adjuvant endocrine therapy (ET), a patient group considered to have a particularly high unmet need. The proposed enrichment strategy in ESR1 mutation (ESR1m) allows assessment of the co-primary endpoints in the ESR1m subgroup, who have worse prognosis and who are more likely to derive the greatest benefit from novel oral selective estrogen receptor- antagonists and degraders (SERDs) like giredestrant, and in the full study population, inclusive of participants without an ESR1 mutation detected (ESR1nmd).
Title: A phase II randomised controlled trial to determine the efficacy of combining the HDAC inhibitor sodium valproate with EGFR monoclonal antibody (panitumumab or cetuximab) maintenance in the first-line treatment of patients with RAS wild type metastatic CRC (VADER study)
Trial summary: The aim of this study is to determine the efficacy of combining the histone deacetylase (HDAC) inhibitor sodium valproate (VPA) with anti-EGFR monoclonal antibody (panitumumab or cetuximab) maintenance in the first-line treatment of patients with RAS wild type metastatic CRC.
The below are a list of trials being run outside of the clinical trials unit.
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.
Trial Summary:
This study aims to detect if there is a difference between activating your deep core muscles or your outer abdominal muscles in reducing the seperation of the abdominal muscles in women with diastasis of the rectus abdominis muscles following vaginal childbirth.
Trial Recently Completed
Trial Summary:
Diastasis of the rectus abdominis muscle (DRAM or DRA) is a common condition postpartum where the abdominal muscles seperate along the linea alba. Current physiotherapy management is overwhelmingly reported to include transversus abdominis (TrA) training, however, ultrasound imaging evidence is growing to support rectus abdominis (RA) training in the early postpartum period instead. While ultrasound imaging has previously shown contraction of the TrA muscle increases the inter-recti distance and RA reduces it, no current evidence exists comparing the two when prescribed as a treatment.
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.