Clinical Trials and Studies

Since its inception in 2008, ANZSA has been involved in more than 30 sarcoma-related studies and clinical trials, both locally and internationally.

Here you will find a list of research studies and clinical trials led or participated by ANZSA that are open for recruitment. If you are interested in taking part in a clinical trial, please discuss it with your doctor.

For the complete list of sarcoma-related clinical trials in Australia, including those that are not managed by ANZSA, please visit the Australian Clinical Trials registry

Information accurate as of 07/07/2021

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
Recruitment Status
Open
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
Monash Children's Hospital, Prince Charles Hospital, Queensland Children's Hospital, Royal Children's Hospital, Sydney Children's Hospital, Women's and Children's Hospital, Chris O'Brien Lifehouse, Peter MacCallum Cancer Centre, Princess Alexandra Hospital, Westmead 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.
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.
Recruitment Status
Open
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
  1. 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.
  2. 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
  3. 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
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.
Recruitment Status
Open
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, Monash Children's Hospital, Prince of Wales Hospital, Sydney Children's Hospital, Perth Children’s Hospital, Queensland Children’s Hospital, Princess Alexandra Hospital, Chris O’Brien Lifehouse, John Hunter Children’s Hospital, Royal Adelaide Hospital, Starship Children's Hospital (NZ), Christchurch Hospital (NZ)
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).
Recruitment Status
Open
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.
Recruitment Status
Open
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)
CO-SPONSORS
ANZCHOG, ANZSA
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.
Recruitment Status
Open
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)

The ANZSA national sarcoma database is a rich resource of data for Australia sarcoma clinical practice. The database was utilised for following studies.

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 07/07/2021

PEComa
The natural history of primary extra-hepatorenal perivascular epithelioid cell tumours (PEComa) of the retroperitoneum: The combined experience of The Australasian Retroperitoneal Sarcoma Working Group (TARPSWG)

Summary
The natural history of primary extra-hepatorenal perivascular epithelioid cell tumours (PEComa) of the retroperitoneum: The combined experience of The Australasian Retroperitoneal Sarcoma Working Group (TARPSWG)
Recruitment Status
Retrospective database study
Eligible Cohort
N/A
PHASE
N/A
RECRUITMENT TARGET
N/A
EXPECTED COMPLETION
2021
COUNTRY PI
A/Prof David Gyorki, Dr Sameer Apte
PARTICIPATING SITES
Peter MacCallum Cancer Centre
CO-SPONSORS
TARPSWG and ANZSA
Desmoid PoC
Patterns of care in management of desmoid fibromatosis

Summary
This is a retrospective study to describe the patterns of care and clinical outcomes for patients with desmoid tumours (DT) managed at the Peter MacCallum Cancer Centre.
Recruitment Status
Retrospective database study
Eligible Cohort
N/A
PHASE
N/A
RECRUITMENT TARGET
N/A
EXPECTED COMPLETION
2021
COUNTRY PI
Dr Julie Chu, Dr Susie Bae, Dr Lisa Orme
PARTICIPATING SITES
Peter MacCallum Cancer Centre
CO-SPONSORS
ANZSA
Ewings PoC
Patterns of care for adolescents and adult patients with Ewing’s family sarcomas

Summary
This is a retrospective review that will be undertaken in order to assess the pattern of care, chemotherapy delivery and outcomes in patients with Ewing’s family sarcomas (EFS) in routine practice.
Recruitment Status
Retrospective database study
Eligible Cohort
N/A
PHASE
N/A
RECRUITMENT TARGET
200
EXPECTED COMPLETION
2021
COUNTRY PI
Dr Yeh Chen Lee
PARTICIPATING SITES
Prince of Wales Hospital, Chris O'Brien Lifehouse, Peter MacCallum Cancer Centre, Sydney Children's Hospital
CO-SPONSORS
ANZSA
Desmoids
The Evaluation and Outcome of Mesenteric and Intra-Abdominal Desmoids: A study by the TARPSWG

Summary
The aim of this project is to better understand the clinical presentation of mesenteric and intra-abdominal desmoids and how they progress over time or their outcomes post-surgery.
Recruitment Status
Retrospective database study
Eligible Cohort
N/A
PHASE
N/A
RECRUITMENT TARGET
110
EXPECTED COMPLETION
2021
COUNTRY PI
Dr Hayden Snow
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Chris O'Brien Lifehouse/Royal Prince Alfred Hospital, Princess Alexandra Hospital
CO-SPONSORS
The Ottawa Hospital and ANZSA
Angiosarcoma
Changing patterns of care for patients with angiosarcoma

Summary
This is a retrospective/audit review of outcomes comparing chemotherapy protocols VS the Taxane (Paclitaxel) protocol in the treatment of patients diagnosed with angiosarcoma. The study aims to identify therapeutic and prognostic changes in the care of patients in Australia with angiosarcoma over the past two decades.
Recruitment Status
Retrospective database study
Eligible Cohort
Patients diagnosed with angiosarcoma
PHASE
N/A
RECRUITMENT TARGET
N/A
EXPECTED COMPLETION
2021
COUNTRY PI
Prof Philip Crowe
PARTICIPATING SITES
Prince of Wales Hospital, Chris O'Brien Lifehouse, Peter MacCallum Cancer Centre
CO-SPONSORS
N/A
DATaCare
Delays in Access to Treatment and patterns in primary Care presentations and hospitals

Summary
This project will investigate the health care pathways of patients diagnosed with bone and soft tissue sarcomas with the intent of identifying access barriers and the potential for accurate early diagnosis, particularly relating to primary care and emergency department attendances prior to treatment. It will also analyse presentations in general practice and treatment in hospitals as an indicator of outcomes, quality of life and survivorship for those patients.
Recruitment Status
Retrospective database study
Eligible Cohort
Patients diagnosed with bone and soft tissue sarcomas
PHASE
N/A
RECRUITMENT TARGET
N/A
EXPECTED COMPLETION
2021
COUNTRY PI
Dr Susie Bae
PARTICIPATING SITES
Peter MacCallum Cancer Centre
CO-SPONSORS
ANZSA
CIC-Rearranged Sarcoma
CIC-Rearranged Sarcoma: a review of the Australian experience

Summary
A review of the clinical and pathological features and outcomes of this very rare sarcoma (CIC-rearranged sarcoma) in order to aid in the diagnosis and management of this disease.
Recruitment Status
Retrospective database study
Eligible Cohort
Patients diagnosed with CIC-rearranged sarcoma
PHASE
N/A
RECRUITMENT TARGET
N/A
EXPECTED COMPLETION
2021
COUNTRY PI
Prof Angela Hong
PARTICIPATING SITES
Chris O'Brien Lifehouse, Peter MacCallum Cancer Centre, Prince of Wales Hospital, South Australia Pathology, Princess Alexandra Hospital
CO-SPONSORS
ANZSA
Bone - Adolescents and Young Adults
Patterns of care and outcomes of bone sarcoma in Adolescents and Young Adults (AYA) compared to older adults in Victoria

Summary
Observational retrospective, multicenter registry study performed with data collected from the ACCORD database designed to collect and update clinical data on sarcoma patients from six Australian centres.
Recruitment Status
Retrospective database study
Eligible Cohort
AYA and older adult participants who have histologically confirmed, localised or metastatic bone sarcoma - Ewing or conventional osteosarcoma.
PHASE
N/A
RECRUITMENT TARGET
230
EXPECTED COMPLETION
2020
COUNTRY PI
Dr Katrina Ingley
PARTICIPATING SITES
Peter MacCallum Cancer Centre
CO-SPONSORS
N/A
Mesenchymal Chondrosarcoma
Mesenchymal chondrosarcoma in Australia: a retrospective cohort study

Summary
To determine treatment patterns and outcomes in Australian patients treated for localised and metastatic mesenchymal chondrosarcoma.
Recruitment Status
Retrospective database study
Eligible Cohort
Patients of any age who are diagnosed with localised or metastatic mesenchymal chondrosarcoma. These patients come from sarcoma centres in Australia that participate in the multisite sarcoma database. Patients treated at other sites will be eligible for inclusion.
PHASE
N/A
RECRUITMENT TARGET
20
EXPECTED COMPLETION
2020
COUNTRY PI
Dr Madeleine Strach
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Royal Adelaide Hospital, Prince of Wales Hospital, Royal Prince Alfred Hospital, Sir Charles Gairdner Hospital, Canberra Hospital
CO-SPONSORS
N/A
Advanced Soft Tissue Sarcoma Study: Data Linkage
Treatment patterns, resource utilisation and healthcare costs among patients with advanced soft tissue sarcoma: A data linkage project using a Victorian cohort

Summary
A data linkage project using data from the Australian Comprehensive Cancer Outcomes and Research Database (ACCORD) linked with datasets from the Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), National Death Index (NDI), Victoria admitted episode data set and Victoria Emergency Minimum dataset.
Recruitment Status
Retrospective database study
Eligible Cohort
Retrospective: Adult patients diagnosed with soft tissue sarcoma between 1/01/2010 and 31/12/2015 selected from ACCORD.
PHASE
N/A
RECRUITMENT TARGET
361
EXPECTED COMPLETION
2021
COUNTRY PI
Dr Susie Bae, A/Prof Jayesh Desai
PARTICIPATING SITES
Peter MacCallum Cancer Centre
CO-SPONSORS
ANZSA, Eli Lilly
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
Recruitment Status
Prospective registry
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
CO-SPONSORS
ANZSA
Advanced Soft Tissue Sarcoma Study
Real world treatment patterns and outcomes among patients with advanced soft tissue sarcoma (STS): A database analysis in Australia

Summary
A retrospective cohort study describing pattenrs of care in management of advanced soft tissue sarcoma (STS) at Australian sarcoma referral centres.
Recruitment Status
Retrospective database study
Eligible Cohort
Retrospective: Adult patients diagnosed with STS and seen at six sarcoma centres between 1/01/2010 and 31/12/2015 selected from ACCORD
PHASE
N/A
RECRUITMENT TARGET
637
EXPECTED COMPLETION
2019
COUNTRY PI
Dr Susie Bae, A/Prof Jayesh Desai
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Royal Adelaide Hospital, Prince of Wales Hospital, Royal Prince Alfred Hospital, Sir Charles Gairdner Hospital, Canberra Hospital, Princess Alexandra Hospital
CO-SPONSORS
ANZSA, Eli Lilly
Vascular Soft Tissue Sarcoma Study
Advances in the systemic treatment of angiosarcoma and other vascula-rich soft tissue sarcomas

Summary
Patterns of care study in describing systemic treatment of angiosarcoma and other vascula-rich soft tissue sarcomas.
Recruitment Status
Retrospective database study
Eligible Cohort
Retrospective: 18 years and older adults, diagnosed with advanced angiosarcoma or vascular-rich soft tissue sarcoma
PHASE
N/A
RECRUITMENT TARGET
N/A
EXPECTED COMPLETION
2019
COUNTRY PI
Dr Susie Bae, A/Prof Jayesh Desai
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Royal Adelaide Hospital, Prince of Wales Hospital, Royal Prince Alfred Hospital, Sir Charles Gairdner Hospital, Canberra Hospital
CO-SPONSORS
ANZSA, Novartis
AMOSS
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)
Recruitment Status
Retrospective database study
Eligible Cohort
Retrospective: Male or female, 48 months of age at the date of diagnostic biopsy
PHASE
N/A
RECRUITMENT TARGET
27
EXPECTED COMPLETION
2019
COUNTRY PI
Dr Phoebe Chidly, Dr Susie Bae, Dr Sarat Chander
PARTICIPATING SITES
Peter MacCallum Cancer Centre
CO-SPONSORS
ANZSA