Clinical Trials and Studies
Clinical Trials
Here you will find a list of clinical trials led or participated by ANZSA that are currently active and either open or closed for recruitment. If you are interested in any of these trials, please discuss it with your doctor.
For the complete list of sarcoma-related clinical trials in Australia and New Zealand, including those that are not managed by ANZSA, please visit the Australia New Zealand Clinical Trials Registry.
Information accurate as of 05/12/2024
Inter-EWING 1
International clinical research programme to improve outcomes in newly diagnosed Ewing sarcoma – Trial 1
Summary
This is a multicentre trial which includes multiple randomised questions at multiple points in the treatment pathway in a phase III study with four principal aims. These are to evaluate:
• Randomisation A - introduction of regorafenib
• Randomisation B1 - dose escalation of definitive radical radiotherapy as local therapy to the primary tumour site
• Randomisation B2 - determining the optimal dose of post-operative radiotherapy following surgical resection of the primary tumour site
• Randomisation C - addition of maintenance treatment after the end of consolidation therapy
Eligible Cohort
Patients 2 years and older diagnosed with Ewing sarcoma of bone or soft tissue.
PHASE
III
RECRUITMENT TARGET
• Randomisation A - 300 • Randomisation B1 - 180 • Randomisation B2 - 230 • Randomisation C - 450
EXPECTED COMPLETION
27/05/2032
COUNTRY PI
Prof Marianne Phillips
PARTICIPATING SITES
Perth Children's Hospital, Peter MacCallum Cancer Centre
CO-SPONSORS
University of Birmingham, ANZCHOG
STRASS2
A randomised phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with high risk retroperitoneal sarcoma (RPS)
Summary
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.
After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
Eligible Cohort
Patients 18 years and older diagnosed with primary high risk leiomyosarcoma (LMS) or liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.
PHASE
III
RECRUITMENT TARGET
250 globally
EXPECTED COMPLETION
2028
COUNTRY PI
A/Prof Anne Hamilton/A/Prof David Gyorki
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Chris O'Brien Lifehouse Princess Alexandra Hospital
CO-SPONSORS
European Organisation for Research and Treatment of Cancer (EORTC)
FaR-RMS
A multi-arm-multistage study for children and adults with localised and metastatic Frontline and Relapsed Rhabdomyosarcoma (RMS)
Summary
FaR-RMS is an over-arching study for patients with newly diagnosed and relapsed RMS including multi-arm, multi-stage questions with three principal aims. These are to evaluate:
- systemic therapy through the introduction of new agent regimens in the most advanced disease states: Very High Risk (VHR), High Risk (HR) and Relapse
- the duration of maintenance therapy
- radiotherapy to improve local control in VHR, HR and Standard Risk (SR) patients and to treat metastatic disease
Eligible Cohort
Patients diagnosed with rhabdomyosarcoma (newly diagnosed, relapsed and progressive) of all ages (children, teenagers, young adults, and adults)
PHASE
Multi-phase
RECRUITMENT TARGET
N/A
EXPECTED COMPLETION
2032
COUNTRY PI
Prof Angela Hong
PARTICIPATING SITES
Chris O'Brien Lifehouse, Royal Children's Hospital, Peter MacCallum Cancer Centre, The Children's Hospital at Westmead, Perth Children's Hospital, Monash Children's Hospital, Starship Children's Health, Christchurch Hospital, Princess Alexandra Hospital. Westmead Hospital, John Hunter Children’s Hospital
CO-SPONSORS
ANZSA, as a collaborator, wish to acknowledge the following partners:
- Australian and New Zealand Children’s Haematology/Oncology Group (ANZCHOG) as the national sponsor for Australia and New Zealand, with funding support from the Australian Government through the Medical Research Future Fund (MRFF).
- University of Birmingham (UK) as the international sponsor.
rEECur
International randomised controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma
Summary
rEECur is a Multi-Arm, Multi-Stage (MAMS) randomised phase II / phase III, open-label, international trial. Patients will be randomised at trial entry to receive one of up to four regimens.
Eligible Cohort
Ages 4-49, recurrent and refractory Ewing sarcoma
PHASE
Phase II and III
RECRUITMENT TARGET
525
EXPECTED COMPLETION
2023
COUNTRY PI
A/Prof Marianne Phillips, Dr Susie Bae
PARTICIPATING SITES
Peter MacCallum Cancer Centre, The Children's Hospital at Westmead, Perth Children's Hospital, Monash Children's Hospital, Starship Children's Health, Christchurch Hospital, Princess Alexandra Hospital, Westmead Hospital, John Hunter Children’s Hospital, Royal Adelaide Hospital, Women’s and Children’s Hospital, Children’s Hospital Westmead, Sir Charles Gairdner Hospital
CO-SPONSORS
ANZSA, ANZCHOG (Medical Research Future Fund with CanTeen clinical trial grant)
SARC032
A Phase II randomised controlled trial of neoadjuvant pembrolizumab with radiotherapy and adjuvant pembrolizumab in patients with high-risk, localised soft tissue sarcoma of the extremity
Summary
This is a multicenter, randomised phase II trial with an initial safety run-in to test the safety and efficacy of neoadjuvant pembrolizumab with image-guided radiotherapy and adjuvant pembrolizumab compared to radiation therapy alone in patients with clinically localised extremity soft tissue sarcoma at high risk for developing metastatic disease (tumor size > 5 cm, intermediate- to high-grade; approximately 50% risk for distant disease at 2 years).
Eligible Cohort
18 years old and above
PHASE
Phase II
RECRUITMENT TARGET
110
EXPECTED COMPLETION
30 July 2025
COUNTRY PI
Prof Angela Hong
PARTICIPATING SITES
Australia - Peter MacCallum Cancer Centre, Chris O'Brien Lifehouse, Princess Alexandra Hospital; USA treating centres
CO-SPONSORS
ANZSA, Sarcoma Alliance for Research through Collaboration
NORTH
A Phase II study of panobinostat in paediatric adolescent and young adult patients with solid tumours including osteosarcoma, malignant rhabdoid tumour and neuroblastoma
Summary
This is an open label, Phase II, multicentre study evaluating the anti-tumour activity of continuous, low dose of panobinostat in patients with refractory solid tumours stratified by primary histology into osteosarcoma, malignant rhabdoid tumour/atypical teratoid rabdoid tumour (MRT/ATRT) and neuroblastoma.
Eligible Cohort
Patients must be less than 40 years of age and must have been histologically diagnosed with osteosarcoma, neuroblastoma or MRT/ATRT at time of diagnosis or relapse
PHASE
Phase II
RECRUITMENT TARGET
60
EXPECTED COMPLETION
7 March 2022
COUNTRY PI
Dr Paul Wood, A/Prof Jayesh Desai, Prof David Ashley
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Chris O’Brien Lifehouse, Royal Adelaide Hospital, Princess Alexandra Hospital, Monash Children’s Hospital, Sydney Children’s Hospital, Queensland Children’s Hospital, Royal Children’s Hospital, Perth Children’s Hospital, Children’s Hospital Westmead, Royal Hobart Hospital, Women’s and Children’s Hospital, Starship Children’s Hospital (NZ), Christchurch Hospital (NZ), John Hunter Children’s Hospital
CO-SPONSORS
ANZCHOG, ANZSA
QUEST
Quality of life and Experiences of Sarcoma Trajectories
Summary
This is a longitudinal cohort study that aims to gain an insight into the diagnostic pathway for sarcoma patients in order to help improve this pathway and the outcomes for patients in the future.
Eligible Cohort
Patients aged 18 years or over who are diagnosed with sarcoma
PHASE
N/A
RECRUITMENT TARGET
60
EXPECTED COMPLETION
2025
COUNTRY PI
Dr Susie Bae
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Chris O'Brien Lifehouse/Royal Prince Alfred Hospital, Princess Alexandra Hospital, Auckland City Hospital
CO-SPONSORS
ANZSA and the Netherland Cancer Institute
ISKS
International Sarcoma Kindred Study
Summary
ISKS is a global genetic, biological, epidemiological and clinical resource for researchers to investigate important questions relating to the hereditary characteristics of sarcoma.
This project aims to establish an international database and biospecimen repository to be used as a clinical and research resource.
Eligible Cohort
Anybody with adult-onset sarcoma (over 15 years old) is eligible for the study. Family members may also be invited to participate if the person with sarcoma is under 45 years of age or there is a significant history of cancer in the family.
PHASE
N/A
RECRUITMENT TARGET
3000
EXPECTED COMPLETION
Ongoing
COUNTRY PI
Prof David Thomas, Dr Mandy Ballinger
PARTICIPATING SITES
Garvan Institute of Medical Research, Peter MacCallum Cancer Centre; together with international sites in France, USA, New Zealand, India, UK, Canada and South Korea
CO-SPONSORS
ANZSA, Rainbows for Kate Foundation, National Health and Medical Research Council, Victorian Cancer Agency, Cancer Australia, UK Sarcoma Trust, Liddy Shriver Sarcoma Initiative
PUBLICATIONS &
PRESENTATIONS
PRESENTATIONS
- Thomas DM, Ballinger ML. Etiologic, environmental and inherited risk factors in sarcomas. J Surg Oncol. 2015 Apr;111(5):490-5. doi: 10.1002/jso.23809. Epub 2014 Oct 21.
- Kate A. McBride; Nina Hallowell; Martin H.N. Tattersall ; Judy Kirk ; Mandy L. Ballinger; David M. Thomas; Gillian Mitchell & Mary-Anne Young. Timing and Context: Important considerations in the return of genetic results to research participants. Journal of Community Genetics 2015, DOI 10.1007/s12687-015-0231-7
- Ballinger ML, Mitchell G, Thomas DM. Surveillance recommendations for patients with germ-line TP53 mutations. Current Opinion in Oncology 2015, Vol 27 No 4 p332-337
Retrospective Database Research Studies
Retrospective research studies collect data
Since its inception in 2008, ANZSA has been involved in more than 50 retrospective data collection studies, both locally and internationally. These studies involve analysis of data collected retrospectively from a variety of medical resources. Many of these studies utilise the ANZSA national sarcoma database which is a rich resource for sarcoma research.
As an ANZSA member, you are eligible to utilise data from our database for your sarcoma research or study. To find out more about our database and how you can utilise it, visit the Clinical Data page.
Information accurate as of 5/12/2024
PUSH-Rms
International Multicenter Retrospective Study Of Pleomorphic Rhabdomyosarcoma (P-Rms) And Spindle Cell/ Sclerosing Rhabdomyosarcoma (S-Rms), A Push Platform Study
Summary
A multi-centered international retrospective study conducted to provide valuable insights into the activity of systemic agents for P-Rms/S-Rms
across all age groups. This will be used as a backbone for further discussion on how to optimize the treatment of these patients.
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
2025
COUNTRY PI
Dr Susie Bae
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Royal Prince Alfred, NSW Health Pathology, Princess Alexandra, SA Pathology, PathWest WA.
CO-SPONSORS
n/a
Surveillance
Primary retroperitoneal, abdominal, and pelvic soft tissue sarcomas: impact of post-operative radiological surveillance intensity on oncological outcomes and management of distant and locally recurrent disease
Summary
An international retrospective study looking at the impact of imaging and imaging intensity on quality of life and long-term oncological outcomes.
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
2025
COUNTRY PI
Prof David Gyorki
PARTICIPATING SITES
Royal Prince Alfred, Peter MacCallum Cancer Centre
CO-SPONSORS
n/a
Retrospective CT
A retrospective analysis to evaluate neoadjuvant and adjuvant chemotherapy for soft tissue sarcoma
Summary
Evaluate the relapse free survival and overall survival of patients with soft tissue sarcoma receiving curative intent neoadjuvant/adjuvant chemotherapy compared to those who had surgery alone.
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
2024
COUNTRY PI
Dr Adel Shahnam
PARTICIPATING SITES
Peter MacCallum Cancer Centre
CO-SPONSORS
n/a
Uterine Sarcoma
A Multisite Retrospective Review of Clinical Characteristics of Uterine Sarcoma
Summary
A Multisite Retrospective Review of Clinical Characteristics of Uterine Sarcoma.
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
2024
COUNTRY PI
Dr Eyal Mor
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Royal Women's Hospital
CO-SPONSORS
n/a
PABR
Standard Palliative Radiotherapy (SPR), Partially Ablative Body Radiotherapy (PABR) or Systemic Therapy (ST) for Symptomatic, Bulky and Unresectable Sarcomas: Experience at the Peter MacCallum Cancer Centre
Summary
Retrospective and prospective study of use of PABR in unresectable and metastatic sarcomas. Completed a comparative retrospective analysis of patients treated with conventional palliative RT Vs PABR, similar analysis of palliative chemotherapy/systemic
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
2025
COUNTRY PI
Dr Luke Im, Dr Christopher Williams, Dr Kelvin Yu
PARTICIPATING SITES
Peter MacCallum Cancer Centre
CO-SPONSORS
n/a
Extremity Sarcoma
Extremity Soft-Tissue Sarcoma, A Review of Outcomes for Patients Presenting with Both Localised and Metastatic Disease
Summary
Project 1 – A retrospective review of patients aged >65 years of age with extremity soft tissue sarcoma, to assess outcomes. Project 2 – A retrospective review of all patients presenting with metastatic extremity soft tissue sarcomas to determine outcomes
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
2024
COUNTRY PI
Dr Elan Novis
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Prince Of Wales, Royal Adelaide Hospital, Royal Prince Alfred, Sir Charles Gairdner
CO-SPONSORS
n/a
ISarc
Inguinal Sarcomas - A retrospective analysis of diagnosis, clinical features, treatment patterns and outcomes (I-Sarc): A study by TARPSWG
Summary
The aim is to evaluate the heterogeneity of treatment for inguinal sarcomas using the largest international collaboration on these rare tumors.
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
2025
COUNTRY PI
Dr Hayden Snow
PARTICIPATING SITES
Chris O'Brien Lifehouse, Royal Prince Alfred, Peter MacCallum Cancer Centre
CO-SPONSORS
n/a
GCT
Giant Cell Tumours - treatment with denosumab
Summary
Evaluating the treatment of Giant Cell Tumours with denosumab
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
2024
COUNTRY PI
Dr Madeleine Strach
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Prince Of Wales, Royal Adelaide Hospital, Royal Prince Alfred, Sir Charles Gairdner
CO-SPONSORS
n/a
Chordoma
Patterns of care and outcomes in Chordoma
Summary
Audit of all chordoma cases treated at Peter MacCallum Cancer Centre, to characterise patterns of care and evaluate their impact upon disease control rate.
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
2024
COUNTRY PI
Dr Kendrick Koo
PARTICIPATING SITES
Peter MacCallum Cancer Centre
CO-SPONSORS
n/a
AYA Retrospective
Adolescent/Young Adults Retrospective Study on Ewings, Osteosracoma and Soft Tissue Sarcoma
Summary
Pattern of care for AYA cohort 15-39 with breakdown of Ewings, osteosarcoma and soft tissue sarcoma
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
2024
COUNTRY PI
Dr Madeleine Strach
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Prince Of Wales, Royal Adelaide Hospital, Royal Prince Alfred, Sir Charles Gairdner
CO-SPONSORS
n/a
AMOSS-2
Aggressive management of oligometastatic paediatric and adult sarcomas with either extirpative surgery and/or stereotactic ablative radiotherapy (SABR)
Summary
Patterns of care study describing the use of aggressive management of oligometastatic paediatric and adult sarcomas with either extirpative surgery and/or stereotactic ablative radiotherapy (SABR)
Eligible Cohort
n/a
PHASE
Retrospective database study
RECRUITMENT TARGET
50
EXPECTED COMPLETION
2024
COUNTRY PI
Dr Tas Gnanasekaran
PARTICIPATING SITES
Peter MacCallum Cancer Centre
CO-SPONSORS
n/a
Clinical Studies
A clinical study is a propective study (future data collection) that does not involve testing of an intervention (a medication)
Here you will find a list of clinical studies (studies without an intervention) led or participated by ANZSA that are currently active and either open or closed for recruitment. If you are interested in any of these studies, please discuss it with your doctor.
LMS Biomarker
Observational Study of Biomarkers of Disease-related Outcomes in Patients
Summary
This study is examining the correlation of change in the biomarker ctDNA with progression free survival. Blood and tissue will be collected at baseline and various timepoints for DNA analysis. Imaging will also be collected for analysis.
Eligible Cohort
Patients with unresectable or metastatic leiomyosarcoma (LMS) who are receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel for treatment of advanced/metastatic disease.
PHASE
N/A
RECRUITMENT TARGET
40
EXPECTED COMPLETION
2030
COUNTRY PI
A/Prof Peter Grimison
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Chris O'Brien Lifehouse
CO-SPONSORS
University of Michigan
MYTH
Methotrexate for AYAs in The Home
Summary
This is a prospective multi-centre single arm intervention study of an ambulatory care program, for delivery of high dose methotrexate, in Australian Adolescent and Young Adult (AYA) osteosarcoma patients
Eligible Cohort
Patients diagnosed with osteosarcoma receiving methotrexate, age 15- 39, who have successfully completed 2 cycles of methotrexate under inpatient conditions without complications.
PHASE
n/a
RECRUITMENT TARGET
10
EXPECTED COMPLETION
31/12/2025
COUNTRY PI
Dr Elizabeth Connolly
PARTICIPATING SITES
Chris O'Brien Lifehouse, Children's Hospital at Westmead-soon to open
CO-SPONSORS
Chris O'Brien Lifehouse
SMOC+
A surveillance study utilising whole body magnetic resonance imaging and other surveillance procedures in people with germ line cancer gene mutations to investigate the prevalence and incidence of investigable lesions
Summary
A surveillance study utilising whole body magnetic resonance imaging (MRI) and other surveillance procedures in people with germ line cancer gene mutations to investigate the prevalence and incidence of investigable lesions.
Eligible Cohort
18-70 years old with known cancer risk gene pathogenic mutation carrier or family member at 50% risk of carrying a mutation
PHASE
N/A
RECRUITMENT TARGET
150
EXPECTED COMPLETION
2020
COUNTRY PI
Prof David Thomas
PARTICIPATING SITES
Monash Medical Centre - Clayton campus, St Vincent's Hospital - Darlinghurst, Prince of Wales Hospital - Randwick, Peter MacCallum Cancer Centre - Melbourne
CO-SPONSORS
ANZSA Johanna Sewell Sarcoma Research Grant, ANZSA/Cancer Australia (PdCCRS)
Registry Projects
A registry is a propective study (future data collection) that does not involve testing of an intervention (a medication)
Here you will find a list of clinical studies (studies without an intervention) led or participated by ANZSA that are currently active and either open or closed for recruitment. If you are interested in any of these studies, please discuss it with your doctor.
ReLaPSe
Prospective study evaluating the treatment outcomes for localised Recurrent, resectable retroperitoneal LiPoSarcoma (ReLaPSe)
Summary
This study is collecting participant data prospectively from hospital medical records. Participant details regarding diagnosis, treatments, outcomes, complications and survival status will be captured after patients are enrolled into the study and at specific time.
Eligible Cohort
Adult age ≥ 18 presenting with first recurrent well-differentiated and/or dedifferentiated liposarcoma of retroperitoneal space or pelvis after previous macroscopically complete resection.
PHASE
Prospective registry
RECRUITMENT TARGET
n/a
EXPECTED COMPLETION
27/05/2032
COUNTRY PI
Prof Angela Hong
PARTICIPATING SITES
Royal Prince Alfred Hospital, Prince of Wales Hospital
CO-SPONSORS
ANZSA and Transatlantic Australasian Retroperitoneal Sarcoma Working Group (TARSWG)
Myxoid Liposarcomas (MLS) Registry
International prospective registry on local treatment in myxoid liposarcomas (MLS)
Summary
This study aims to assess optimal local treatment strategies in MLS and, more specifically, the role of radiation therapy with respect to local control, patient-reported outcome measures (PROMs) and Health-Related Quality of Life (HRQoL).
Eligible Cohort
Patients aged 18 or over who are diagnosed with MLS.
PHASE
N/A
RECRUITMENT TARGET
N/A
EXPECTED COMPLETION
Ongoing
COUNTRY PI
Prof Angela Hong
PARTICIPATING SITES
Chris O'Brien Lifehouse, Royal Adelaide Hospital, Peter MacCallum Cancer Centre, Westmead Hospital, Canberra Hospital, Princess Alexandra Hospital
CO-SPONSORS
ANZSA and the Netherland Cancer Institute
RESAR
Retroperitoneal Sarcoma Registry (RESAR): prospective collection of primary retroperitoneal sarcoma patient's clinical, radiological and pathology data for the TransAtlantic Retroperitoneal Sarcoma Working Group
Summary
Prospective collection of primary retroperitoneal sarcoma patient's clinical, radiological and pathology data for the TransAtlantic Retroperitoneal Sarcoma Working Group
Eligible Cohort
Primary Retroperitoneal sarcoma operated on in the participating center; age>18 years at the time of the first treatment, histological confirmed diagnosis according to the WHO criteria done on biopsy or surgical specimen by dedicated sarcoma pathologist
PHASE
N/A
RECRUITMENT TARGET
2000
EXPECTED COMPLETION
2030
COUNTRY PI
Mr David Gyorki
PARTICIPATING SITES
Australia - Peter MacCallum Cancer Centre, Princess Alexandra Hospital, Royal Prince Alfred Hospital, Royal Adelaide Hospital
CO-SPONSORS
ANZSA