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Clinical trials

Clinical trials are an important part of our department's research. Clinical trials helps to investigate the effectiveness of new treatment techniques by comparing them with existing ones. The new techniques are offered to patients who could benefit their radiotherapy treatment. Our doctors will then find evidence on how to improve treatment techniques. The results may then be published in peer review journals or presented at professional conferences, leading to an improvement in patient treatment.

If you are interested in participating in a clinical trial, you can speak to your radiation oncologist. You can also read about our current clinical trials below.

 

Image of a seated woman being attend by an woman clincian 

 

 Current clinical trials

If you are a patient having radiation therapy you might be eligible to participate in one or more of our clinical trials.

New patients are currently being recruited to the following clinical trials. For more information please speak with your radiation oncologist.

 

Urology

Trial name: KIM Gating - Radiation Beam Gating using Kilovoltage Intrafraction Monitoring (KIM) for Prostate Cancer RadiotherapyCAPRI

Site principal investigator: Professor Thomas Eade

Aim: The purpose of this study is to monitor movement of the prostate during radiotherapy and pause the treatment if the prostate moves more than 3mm. The aim of this is to ensure the prostate cancer receives the highest dose while minimising side effects to the rectum or bladder

Trial registration ID:NCT01742403

 

Trial name: HEAT - Hypofractionation via Extended versus Accelerated Therapy

Site principal investigator: Professor Thomas Eade

Aim: The purpose of this research study is to compare the effectiveness and side effect profile of two different radiation therapy regimens to the prostate gland, 'external beam radiation therapy' and 'stereotactic radiotherapy'.

Trial registration ID: NCT01794403

 

Trial name: RETREAT – Stereotactic Re-irradiation of prostate Cancer Recurrence within the Definitively Irradiated Prostate

Site principal investigator: A/Prof George Hruby

Aim: This study aims to examine the feasibility and safety of using SBRT (precision external beam radiation, called Stereotactic Radiotherapy) to treat prostate cancer that has recurred locally after having external beam radiotherapy (EBRT) previously. Early data of SBRT has shown that it is a safe and effective way to retreat prostate cancer that has recurred.

Trial registration ID:NCT03073278

 

Trial name: OPTIMAL - Optimal Prostate Fractionation Study

Site principal investigator: To compare two new radiotherapy approach directly with standard radiotherapy and find out if the new radiation approaches are as well tolerated by patients and as effective as the standard treatment.

Aim: Professor Andrew Kneebone

Trial registration ID:NCT03386045

 

Trial name: PCR-MIB - Pembrolizumab with ChemoRadiotherapy as treatment for Muscle Invasive Bladder Cancer

Site principal investigator: A/Prof George Hruby

Aim: This study aims to use a new drug called pembrolizumab combined with chemotherapy and radiation therapy to see if this combination might improve outcomes for patients with bladder urothelial cancers

Trial registration ID:NCT02662062

 

Breast

Trial name: BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for sparing the Heart

Site principal investigator: Dr Gillian Lamoury

Aim: This study is looking at whether a new audio-visual feedback device, called 'Breathe Well', is better than the current technology, called Real-time Position Management (RPM/RGSC) in assisting patients to hold their breath

Trial registration ID:NCT02881203

 

Lung

Trial name: VALKIM - Validation of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging using implanted fiducials: Phase I Observational Study of Lung Cancer Radiotherapy

Site principal investigator: Dr Dasantha Jayamanne

Aim: To test whether additional imaging during radiotherapy treatment can detect the lung tumour position compared against an existing standard of care to detect implanted fiducial markers. Detecting the tumour rather than fiducial markers is called 'markerless tracking and is used to detect the position of the lung tumours in the lung as they move with natural breathing motion.

Trial registration ID:NCT04310891

 

Gastro Intestinal

Trial name: LiverInspectr - Liver function Investigation with Single Photon Emission Computed Tomography after Radiotherapy

Site principal investigator: Professor Andrew Kneebone

Aim: Use of medical imaging to measure liver function before and after radiotherapy. It is hoped that by measuring how the liver changes after radiotherapy, we can learn more about how radiation affects the liver. We can also learn whether a certain nuclear medicine scan, known as a SPECT scan, can tell us how to deliver radiation therapy to liver cancers to best reduce side effects.

Trial registration ID:NCT02967848

 

Trial name: SPAN-C - Stereotactic Body Radiotherapy [SBRT] for High risk pancreatic cancer

Site principal investigator: A/Prof George Hruby

Aim: The aim of this study is to see if a newer radiotherapy technique called stereotactic body radiotherapy (SBRT) can improve outcomes for patients with pancreatic cancer. SBRT is a non-invasive radiotherapy treatment that can deliver a higher dose of radiotherapy in far fewer treatments than conventional radiotherapy. It has been used to treat liver and lung cancer for years and has been proven to be safe, and more effective than conventional Radiotherapy.

Trial registration ID:NCT03505229

 

Trial Name: Masterplan - MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease

Site principal investigator: Professor Andrew Kneebone

Aim: To determine if adding focussed, high dose radiotherapy to chemotherapy prevents tumour growth in people with either high-risk (potentially operable) or locally advanced (inoperable) pancreatic cancer.

Trial Registration ID:ACTRN12619000097145

 

Central Nervous System

Trial name: ROAM - Radiation versus Observation following surgical resection of Atypical Meningioma

Site principal investigator: A/Prof Michael Back

Aim: To determine whether early external beam radiotherapy reduces the risk of tumour recurrence or death, compared to active monitoring in newly diagnosed atypical meningioma

Trial registration ID:ISRCTN71502099

 Clinical trials in set-up

We are always working on the set up of new clinical trials which help to improve patient care. The following clinical trials are not available for recruiting patients yet, but will be available for our future patients soon.

 

Breast

Trial name: SVIFT - Standard versus Investigational Fractionation Trial – Nodal radiation

Site principal investigator: A/Prof Susan Carroll

Aim: To determine whether hypofractionated radiotherapy is better tolerated by breast cancer patients, compared to standard radiotherapy

Trial registration ID:

 

Brain

Trial name: FIG - Prospective, multicentre trial evaluating FET-PET in Glioblastoma

Site principal investigator: A/Prof Michael Back

Aim: To see whether using FET-PET will help to more accurately define the tumour and treatment area for radiotherapy planning and improve both treatment decisions and outcomes for patients with GBM compared to standard MRI. FET-PET is a newer form of imaging using Positron Emission Tomography (PET), where a radiotracer called FET, and a chemical compound, is used to detect whether tumour cells are active or not.

Trial registration ID:ACTRN12619001735145p

 

General

Trial name: ASPIRE single – Advanced techniques for single- fraction palliative radiotherapy vs standard single-fraction radiation

Site principal investigator: Professor Thomas Eade

Aim: The aim of the study is to find out if the new treatment, single fraction dose escalated palliative radiotherapy, will improve cancer symptoms respond to radiation without an increase in side effects

Trial registration ID:NCT04658537

 

Trial name: ASPIRE Multi- advanced techniques for single fraction palliative radiotherapy vs standard multi-fraction radiation

Site principal investigator: Professor Thomas Eade

Aim: The aim of the study is to find out if the new treatment techniques will improve cancer symptoms respond to radiation without an increase in side effects

Trial registration ID:NCT04649125

 Past clinical trials

You can learn more about our past clinical trials which have now closed for recruiting patients. This means we are up to our next stage of following up with the remaining patients, and analysing the important findings from the study.

 

Breast

Trial name: IBIS II – An international multi-centre study of Tamoxifen vs Anastrozole in postmenopausal women with hormone sensitive Ductal Carcinoma In Situ (DCIS)

Site principal investigator: Dr Gillian Lamoury

Aim: Whether anastrozole is as effective as or better than tamoxifen in preventing the development of breast cancer in the same breast as the DCIS, or in the opposite breast, in postmenopausal women who have been diagnosed with DCIS.

Trial registration ID:ACTRN12605000282684

 

Trial name: STARS - A randomized comparison of anastrozole commenced before and continued during adjuvant radiotherapy for breast cancer versus anastrozole and subsequent antioestrogen therapy delayed until after radiotherapy (STARS – Study of Anastrozole and Radiotherapy Sequencing)

Site principal investigator: Dr Gillian Lamoury

Aim: To determine if it is better to use an anti-oestrogen medication called anastrozole during radiotherapy, or wait to use anastrozole and other anti-oestrogen medications after radiotherapy

Trial registration ID:NCT00887380

 

Urology

Trial name: RAVES – Radiotherapy Adjuvant Versus Early Salvage

Site principal investigator: Professor Andrew Kneebone

Aim: The aim of the study is to see whether patients treated with active surveillance (and giving radiotherapy as soon as the PSA rises) is as good as immediate radiotherapy. This study will also compare the side effects occurring in each treatment group and what affect the treatments have on quality of life.

Trial registration ID:NCT00860652

 

Trial name: ENZARAD - Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer

Site principal investigator: Professor Andrew Kneebone

Aim: The aim of this study is to see if a new drug, enzalutamide, combined with the current best available treatments, can improve outcomes for men having RT for localised prostate cancer at high risk of recurrence.

Trial registration ID:NCT02446444

 

Trial name: BOOSTER - Early Investigation of High Precision Radiotherapy Prior to Commencing Standard Radiotherapy for Prostate Cancer

Site principal investigator: Professor Thomas Eade

Aim: The purpose of this study is to assess the effects of giving two separate high doses of a special type of precision radiotherapy to the prostate and then 5 weeks (instead of 8 weeks) of standard radiotherapy. Current standard treatment for prostate cancer involves giving patients approximately 40 doses of radiotherapy, one dose per day over an 8 week period.

Trial registration ID:NCT02004223

 

Lung

Trial name: LIGHTSABR - Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking

Site principal investigator: Professor Thomas Eade

Aim: To monitor movement of your lung tumour during radiotherapy and adjust the radiation beam to account for any motion seen. This will decrease the radiation to the surrounding healthy tissue, making sure that the tumour received the whole intended radiotherapy dose

Trial registration ID:NCT02514512

 

Central Nervous System

Trial name: CATNON - Phase III Trial of Anaplastic Glioma Without 1p/19q LOH

Site principal investigator: Dr Helen Wheeler

Aim: Study which is examining whether a chemotherapy drug temozolomide (Temodal®) given in addition to radiotherapy (known as concurrent treatment) or the addition of temozolomide treatment after the completion of radiotherapy (known as adjuvant treatment) will improve the results of treatment overall.

Trial registration ID:NCT00626990

 Medical Oncology clinical trials

We collaborate closely with the Medical Oncology department and work together as part of a multidisciplinary team. Below is a list of Medical Oncology clinical trials, which our doctors have been involved in.

 

Trial name: TRAP Intrepid lung 005 - M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

Tumour site: Lung

Site principal investigator: A/Prof Nick Pavlakis

Aim: To evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab. - Currently recruiting

Trial registration ID:NCT03840902

 

Trial name: KEYNOTE 630 - Pembrolizumab Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma

Tumour site: Skin

Site principal investigator: A/Prof Alex Guminski

Aim: To compare pembrolizumab with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. - Currently recruiting

Trial registration ID:NCT03833167

 

Trial name: I-MAT - Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma

Tumour site: Skin

Site principal investigator: A/Prof Alex Guminski

Aim: To develop an effective, well-tolerated adjuvant immunotherapy regimen for patients with stage I-III MCC, following local and regional treatment options which includes surgery and/or radiotherapy, where patients will receive either avelumab or a placebo for 6 months. - Currently recruiting

Trial registration ID:NCT04291885

 

Trial name: CAPRI - Combined radiotherapy and immunotherapy for men with early metastatic prostate cancer not on hormone therapy

Tumour site: Prostate

Site principal investigator: A/Prof Alex Guminski

Aim: To document the efficacy and safety of MEDI4736 in combination with stereotactic body radiotherapy in androgen intact men with oligometastatic prostate cancer detected on Ga68-PSMA scanning after biochemical relapse of definitively treated prostate cancer. - Currently recruiting

Trial registration ID:ACTRN12619000097145

 

Trial name: AveRec - Avelumab With Chemoradiation in Locally Advanced Rectal Cancer

Tumour site: Gastro Intestinal

Site principal investigator: A/Prof Nick Pavlakis

Aim: To investigate the inclusion of avelumab post long-course chemo-radiotherapy in patients with resectable locally advanced rectal cancer. - Currently recruiting

Trial registration ID:NCT03299660

 

Trial name: CHECKMATE 548 - An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma

Tumour site: Brain

Site principal investigator: Dr Helen Wheeler

Aim: To evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy, and be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy. – Not recruiting, patient in follow up

Trial registration ID:NCT02667587

 

Trial name: MAGMA - The Multi-Arm GlioblastoMa Australasia

Tumour site: Brain

Site principal investigator: Dr Helen Wheeler

Aim: To assess a number of options in standard of care for the management of glioblastoma- Currently recruiting:

  1. Whether to give temozolomide as soon as possible following surgery prior to chemoradiotherapy or start at same time when radiotherapy begins.
  2. Whether to give 6 cycles of adjuvant temozolomide after chemoradiotherapy or continue adjuvant temozolomide until disease progression.

Trial registration ID:ACTRN12620000048987

 

Trial name: NUTMEG - A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide alone in newly diagnosed Elderly patients with Glioblastoma

Tumour site: Brain

Site principal investigator: Dr Helen Wheeler

Aim: To test the effectiveness (how well the treatment works), safety and tolerability of an experimental treatment called nivolumab in combination with standard Chemotherapy (TMZ). - Currently recruiting

Trial registration ID:ACTRN12617000267358