Clinical Trials and Studies
Since its inception in 2008, ANZSA has been involved in more than 13 clinical trials, both locally and internationally.
Here you will find a list of 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 and New Zealand, including those that are not managed by ANZSA, please visit the Australia New Zealand Clinical Trials Registry.
Information accurate as of 30/10/2024
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
CO-SPONSORS
European Organisation for Research and Treatment of Cancer (EORTC)
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
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.
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
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, Chris O'Brien Lifehouse, Royal Children's Hospital, 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
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)
Retrospective Database Research Studies
Since its inception in 2008, ANZSA has been involved in more than 50 retrospective data collection studies, both locally and internationally.
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 30/10/2024
ReLaPSe
Prospective study evaluating the treatment outcomes for localised Recurrent, resectable retroperitoneal LiPoSarcoma (ReLaPSe)
Summary
The aim of the registry is to collect prospective data on the treatment outcomes in patients with first localized, resectable recurrent retroperitoneal well-differentiated and/or dedifferentiated liposarcoma undergoing curative intent treatment.
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
Registry study
RECRUITMENT TARGET
100
EXPECTED COMPLETION
27/05/2032
COUNTRY PI
Prof Angela Hong
PARTICIPATING SITES
Royal Prince Alfred Hospital
CO-SPONSORS
ANZSA and Transatlantic Australasian Retroperitoneal Sarcoma Working Group (TARSWG)
Travel Distance
Travel distance and outcomes in patients with sarcoma
Summary
This is a multicentre retrospective registry-based study aiming to assess impact on travel distance and remoteness on outcomes for patients with sarcoma treated in the three major Australian sarcoma specialist centres in NSW and Victoria. The outcomes of this study may highlight any disparities by geographic location, and provide the bases to improve efforts to diminish impediments caused by travel distance and ultimately improve survival in rural patients with sarcoma.
Eligible Cohort
Eligible patients diagnosed between 1st Jan 2013 – 31st December 2017 will be identified from the ACCORD database.
PHASE
N/A
RECRUITMENT TARGET
500
EXPECTED COMPLETION
2023
COUNTRY PI
Prof. Angela Hong
PARTICIPATING SITES
Peter MacCallum Cancer Centre, Chris O’Brien Lifehouse/Royal Prince Alfred Hospital, Prince of Wales Hospital
CO-SPONSORS
ANZSA
LMS
Predictors of early recurrence and metastasis in Leiomyosarcoma: clinicopathologic and immunohistochemical markers
Summary
This study is designed to increase the ability to identify a target group of high-risk patients and determine their risk factors, which may allow for more intensive treatment or enhanced followup to either reduce relapse risk or enable earlier detection.
Eligible Cohort
Patients with non-metastatic LMS in the trunk wall or extremities and being treated with curative intent that relapse early.
PHASE
N/A
RECRUITMENT TARGET
N/A
EXPECTED COMPLETION
2022
COUNTRY PI
Dr Ganaps Perianayagam
PARTICIPATING SITES
Prince of Wales Hospital, Royal Prince Alfred Hospital, Royal Adelaide Hospital, Peter MacCallum Cancer Centre
CO-SPONSORS
Newcastle University, UK.
ASPS
Activity of immunotherapy in alveolar soft part sarcoma: a retrospective study
Summary
Single site retrospective data collection from medical records that will be contributed to an international, multi-institutional, retrospective study.
Eligible Cohort
Patients with alveolar soft part sarcoma who have received immunotherapy.
PHASE
N/A
RECRUITMENT TARGET
N/A
EXPECTED COMPLETION
2022
COUNTRY PI
Dr Vivek Bhadri
PARTICIPATING SITES
Prince of Wales Hospital, Royal Prince Alfred Hospital, Royal Adelaide Hospital, Peter MacCallum Cancer Centre, Sir Charles Gairdner Hospital
CO-SPONSORS
Musculoskeletal Tumour Board of Excellence Sevilla (MUSTBE SEVILLA), Spain.
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 and Westmead Hospital, Canberra Hospital, Princess Alexandra Hospital
CO-SPONSORS
ANZSA and the Netherland Cancer Institute
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)
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.
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.
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.
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.
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.
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
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.
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
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.
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
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
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.
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)
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