ALTG Concepts in Development and Trials
- Concepts in development
- ALTG 15/001 SABR-OS: A randomised phase II trial to test the feasibility of randomising patients with peripheral stage I non-small cell lung cancer to either Stereotactic Ablative Radiotherapy (SABR) Or Surgery (previously ALTG 12/005 Surgery vs SABR)
- ALTG 14/002 NIVORAD: A randomised phase 2 trial of nivolumab and stereotactic ablative body radiotherapy in advanced non-small cell lung cancer progressing after first or second line chemotherapy
- ALTG 14/001 BR.31: A phase III prospective double blind placebo controlled randomized study of adjuvant MEDI4736 in completely resected non-small cell lung cancer
- ALTG 13/004 OPAL: Online and Phone Assistance for Lung cancer (previously Helpline study)
- ALTG 13/003 Rekindle: testing an online resource to promote sexual wellbeing for both patients and their partners
- ALTG 13/002 Health related quality of life in Malignant Mesothelioma
- ALTG 13/001 TROG 13.01 SAFRON II: Stereotactic Ablative Fractionated Radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial
- ALTG 10/001 PLUNG
- ALTG 09/005 TROG 09.02 CHISEL
ALTG 13/008 PEARL: Investigating the impact of early palliative care – J Yoong, L Mileshkin
- A trial to determine if early referral to palliative care improves the disease-defining symptoms pain, cough and breathlessness of advanced thoracic cancer (NSCLC, SCLC or MPM)
- Planned sample size 200 at approx. 25 ANZ sites
- Collaboration of the ALTG with the Palliative Care Clinical Studies Collaborative
- A Cancer Australia project grant has been awarded, commencing 2016
- Protocol development is ongoing with planned first patient in by Q4 2016
ALTG 15/003 DREAM: A phase II trial of durvalumab with first line chemotherapy in mesothelioma with a safety run in – A Nowak, J Lesterhuis, M Millward, B Robinson, R Lake
- To determine the 6 month PFS, safety and tolerability of durvalumab in combination with cisplatin and pemetrexed in MPM planned for 1st line chemo
- Planned sample size 54 at approx.12 sites
- Protocol finalised and submitted to central ethics
- Feasibility completed, sites selected and informed
- Anticipated study start Q4 2016
ALTG 15/004 BR.34 – A phase III randomized trial of the anti-PD-L1 monoclonal antibody, MEDI4736 tremelimumab and chemotherapy as first-line therapy in advanced (stage IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) CCTG – L Seymour (ALTG PI TBD)
- The overall objective of this phase III randomized trial is to determine if MEDI4736 tremelimumab, when used in combination with first-line platinum-based combined chemotherapy, improves progression-free survival in patients with incurable advanced/metastatic non-squamous NSCLC
- Planned recruitment 600 globally
- Ongoing discussions with CCTG re ALTG participation
ALTG 16/004 Nivolumab in the treatment of brain metastases in patients with small cell lung cancer – P Mitchell
- This study examines nivolumab in combination with radiotherapy and the activity of nivolumab in combination with ipilimumab in SCLC brain metastases
- Planned recruitment approx.. 50
- Initial approval for concept received from Bristol Myers Squibb
- Protocol development ongoing
ALTG 15/001 SABR-OS: A randomised phase II trial to test the feasibility of randomising patients with peripheral stage I non-small cell lung cancer to either Stereotactic Ablative Radiotherapy (SABR) Or Surgery (previously ALTG 12/005 Surgery vs SABR)
This trial was initially submitted as an international collaborative group phase II study titled SABRTOOTH however during 2014 it was recognised that, due to differences in the timing of funding and governance between the UK and Australia, a standalone Australian protocol would need to be developed. As a result, the SABR-OS phase II study was approved for development by the TROG Scientific committee in February 2015 (with ALTG collaboration). It is anticipated that the SABRTOOTH and SABR-OS trials will proceed to a joint international phase III trial.
This trial aims to assess the feasibility of recruiting patients, with histologically confirmed peripheral stage I NSCLC who are at higher risk of mortality and morbidity after surgery, into trial that randomises between multi-fraction Stereotactic Ablative Body Radiotherapy (SABR) and surgery (lobectomy or sub-lobar resection). Disease free and overall survival, toxicity and selected patient-reported outcomes will be assessed as secondary endpoints. A sub study looking at economic evaluation and a study of patient preferences using Discrete Choice Experiment (DCE) will also be included in the protocol.
This study aims to recruit 72 participants over 3 years and the protocol is under development, with recruited expected to commence later in 2016.
ALTG 14/002 NIVORAD: A randomised phase 2 trial of nivolumab and stereotactic ablative body radiotherapy in advanced non-small cell lung cancer progressing after first or second line chemotherapy
NIVORAD is a trial to determine the activity and safety of combining nivolumab with local, palliative SABR to an extra-thoracic metastasis in patients with advanced NSCLC. The planned sample size is 120 at approximately 25 ANZ sites and lead HREC approval was received in December 2015. Participating sites are currently completing local governance requirements. The trial is planned to open to recruitment in July 2016.
Study Chair: Paul Mitchell (Paul.email@example.com)
CTC Trial Coordinator: Annie Yeung (firstname.lastname@example.org)
ALTG 14/001 BR.31: A phase III prospective double blind placebo controlled randomized study of adjuvant MEDI4736 in completely resected non-small cell lung cancer
BR.31 is a Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 in Completely Resected Non-Small Cell Lung Cancer.
This multicentre, international trial is being coordinated by the NCIC Clinical Trials Group in collaboration with the NHMRC Clinical Trials Centre and ALTG. The study opened to recruitment in late July 2015, with a plan to recruit 200 patients across 25 Australian and 1 New Zealand site over a 3 year period.
This study is looking at the impact of adjuvant therapy with MEDI4736 (Astra Zeneca) given by intravenous infusion for one year on the disease free survival of patients with early stage (IB >4cm, II or IIIA) NSCLC that is PD-L1 positive.
|Site Name||Principal Investigator||Activation date||Recruitment to date|
|Austin Hospital||Shane White||22 Jan 2016|
|Border Medical Oncology||Craig Underhill|
|Campbelltown Hospital||Po Yee Yip||16 Dec 2015|
|Canberra Hospital||David Leong|
|Canterbury Regional Cancer and Haematology Service||David Gibbs||19 Nov 2015|
|Central Coast Cancer Centre||Matthew Chan||1 Oct 2015|
|Chris O’Brien Lifehouse||Steven Kao||11 Dec 2015||1|
|Coffs Harbour Health Campus – NCCI||Karen Briscoe||24 July 2015|
|Epworth Richmond Hospital||Ross Jennens||22 July 2015|
|Fiona Stanley Hospital||Andrew Davidson||Planned Apr 2016|
|Flinders Medical Centre||Anand Rose|
|Liverpool Hospital||Victoria Bray||2 Dec 2015|
|Mater Adult Hospital Brisbane||Felicity Murphy (Maternity Leave)
|2 Dec 2015||2|
|Monash Medical Centre||Peter Briggs|
|Nambour General Hospital||Kathleen Houston||19 Nov 2015|
|Nepean Cancer Care Centre||Catherine Crombie||28 Oct 2015||2|
|Northern Cancer Institute St Leonards||Nick Pavlakis||17 July 2015|
|Peninsula Oncology Centre, Frankston, Victoria||Vinod Ganju||2 Mar 2016|
|Prince Charles Hospital||Brett Hughes||8 Oct 2015|
|Princess Alexandra Hospital||Ken O’Byrne||10 Sep 2015|
|Royal Adelaide Hospital||Michael Brown||30 July 2015||2|
|Royal Hobart Hospital||Louise Nott||28 Oct 2015|
|Royal Melbourne Hospital, Parkville, Victoria, Australia||Richard de Boer||18 Aug 2015||1|
|Sir Charles Gairdner Hospital||Michael Millward||8 Oct 2015||3|
|St George Hospital||Chee Lee||20 Nov 2015|
|St Vincent’s Hospital Melbourne including St Vincent’s Private Hospital||Sue-Anne McLachlan
ANZ Study Chair
|5 Aug 2015||3|
|Westmead Hospital||Rina Hui|
Study Chair: Sue-Anne McLachlan Sue-Anne.McLachlan@svha.org.au
CTC Trial Coordinator: Hannora Jurkovic BR.email@example.com
Lung cancer patients often experience poorer prognosis, more severe physical effects and more pronounced psychosocial distress than patients with other major cancers and their numbers are under-represented in accessing telephone helplines provided by the Cancer Council in each state. The OPAL study is a randomised controlled trial that aims to evaluate online versus telephone-based information and support for people with lung cancer. Recently diagnosed lung cancer patients are recruited through participating hospital sites, then after completing a Baseline survey, participants are randomised to one of three types of assistance provided by the Cancer Council NSW.
- Best-standard care (a printed “Understanding Lung Cancer” information booklet);
- Proactive Telephone-Delivered Support and Information from a trained oncology nurse consultant; or
- Proactive Online Delivered (email and live chat) Support and Information from a trained oncology nurse consultant.
Participants are asked to fill out a pen and paper survey at the time of recruitment to the study (baseline), then at 3 and 6 months later.
Recruitment had been tracking lower than was anticipated, however an Australia-wide EOI dissemination in 2015 led to our site recruitment number recently reaching 48 sites (note: 45 sites have ethical approval and are currently recruiting or will commence recruiting soon; the remainder are still in the SSA/RGO ethics phase). We have participating sites in all Australian states except NT and ACT, with the bulk of sites being located in NSW, QLD, VIC and WA. New South Wales sites include Calvary Mater Newcastle, Campbelltown Hospital, Liverpool Hospital, Concord Hospital, Manning Hospital, St Vincent’s Hospital, Illawarra Cancer Care Centre, Mid North Coast Cancer Institute, Southern Highlands Cancer Centre, North West Cancer Centre, Central West Cancer Service, Prince of Wales Hospital, Tweed Hospital, Westmead Hospital, Blacktown Hospital, St George Hospital and Sutherland Hospital. Queensland sites include Cameron Oncology at John Flynn Private Hospital, Rockhampton Base Hospital, Genesis Cancer Care (Wesley, Chermside, Tugun, Southport and Nambour sites), Radiation Oncology Centres (Cairns and Gold Coast sites), Mater Health Brisbane, Royal Brisbane and Women’s Hospital and Toowoomba Hospital. Victorian sites include Epworth Richmond Hospital, Monash Clayton, Monash Moorabbin, Mildura Base Hospital, Barwon Health/University Hospital Geelong, South West Oncology, Wimmera Health Care Group (Horsham, Stawell and East Grampians sites), Border Oncology and Peter MacCallum Cancer Centre (Bendigo site). Tasmanian sites include Royal Hobart Hospital. West Australian sites include St John of God (Bunbury, Subiaco and Murdoch sites). South Australian sites include Lyell McEwin Hospital.
To date we have recruited 229 participants to the trial. The 229 participants includes 36 participants who have withdrawn and 37 participants who have passed away. Participant withdrawal has been a continual challenge, attributable to the difficulties in recruiting from the lung cancer patient population.
As of December 2015, Cancer Council NSW consultants had delivered information, support and assistance to 98 participants (40 letters, 48 phone calls, 10 web chats). We are awaiting further data from the Cancer Council NSW regarding updated participant numbers engaging with each intervention arm.
Encouraging participants allocated to the online arm to engage with the online chat service has also been a continual challenge, despite an ethically approved, systematic reminder and follow up process being carried out with online arm participants.
The study will continue until the end of 2016.
If you have any questions about the study please contact Associate Professor Christine Paul Chris.Paul@newcastle.edu.au or (02) 4042 0693.
ALTG 13/003 Rekindle: testing an online resource to promote sexual wellbeing for both patients and their partners
Studies have estimated that between 40-100% of cancer survivors experience negative sexual changes after treatment. Changes to sexuality can lead to psychological and emotional distress for not only survivors, but also their partners, impacting their long-term quality of life. Together, The University of Sydney and Cancer Council NSW are recruiting into an exciting new research study for people who have had cancer and their partners. The Rekindle study aims to investigate and address concerns about sexuality after cancer. The first of its kind, Rekindle is an evidence-based online resource that allows users to choose the level of information that they would like about various principles relating to sexual wellbeing.
The Rekindle Study is a randomised control trial that aims to determine which modality of the Rekindle program is most feasible and encourages greater completion of the prescribed intervention. It also aims to demonstrate the efficacy of Rekindle to improve sexual satisfaction. Participants are randomised into one of the three conditions: Rekindle, Rekindle Plus (Rekindle plus three phone calls), and the Attention Control condition.
After some major changes to the study procedures we restarted recruitment in November 2015 and as at 7 July 2016, 86 participants had been recruited via 30 sites nationally and Cancer Council NSW supportive care activities. The overall recruitment target is 170.
For information or to request materials, contact Douglas Williams, Rekindle Project Manager, at firstname.lastname@example.org
Update January 2016: This project will explore longitudinal HQOL, anxiety and depression and supportive care needs in Mesothelioma. The relationships between HQOL and other prognostic factors such as inflammatory markers, malnutrition and functional status will also be explored.
Participation will involve collecting routine medical information and completing a series of questionnaires at baseline and at regular follow up intervals for 2 years or until death. There will also be the option to participate in additional nutritional and functional assessments, and to donate additional study specific bloods.
The project received ethical approval under the multi-site approval process in August 2013. Site-specific ethics approval has been received for 14 sites across NSW, QLD and SA, with potential expansion to another two sites. To date, 70 participants have been recruited with 41 currently active on the study (20 participants have deceased, 9 have withdrawn). Recruitment rates at each site are listed below.
|Northern Cancer Institute||6|
|Prince of Wales Hospital||2|
|Royal Prince Alfred Hospital||0|
|The Prince Charles Hospital||15|
|Strathfield Private Hospital||0|
|Central West Cancer Service, Orange Health Service||3|
|Macarthur Cancer Therapy Centre, Campbelltown Hospital||2|
|Alan Coates Cancer Centre, Dubbo Base Hospital||0|
|Flinders Medical Centre||0|
|Chris O’Brien LifeHouse||12|
We are recruiting patients at any stage of their disease and their cancer journey. Once a participant has been consented our research team undertakes all ongoing management of their involvement in the study. Any investigators and sites interested in participating will be most welcome, with the opportunity to participate just in questionnaire completion or other optional aspects if resources allow. If you are interested, please contact Jason or Haryana. The project received ALTG endorsement in March 2013 and is supported by a translational research grant from Cancer Institute NSW.
Investigators: A/Prof Janette Vardy, Dr Haryana Dhillon, Dr Steven Kao, Dr Melanie Price, Dr Cindy Tan and Ms Jocelyn McLean.
Study Coordinator: Mr Jason Fowler email@example.com
ALTG 13/001 TROG 13.01 SAFRON II: Stereotactic Ablative Fractionated Radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial
This trial aims to evaluate single fraction SABR (28Gy/1) versus fractionated SABR (48Gy/4) in a randomised phase II trial of 84 patients. This study aims to assess safety of the two techniques and to compare quality of life outcomes, clinical efficacy and the resource usage and costs associated of each technique. This study also aims to establish a fully annotated trial-related bank of blood and pre-treatment tissue for future analysis.
The major inclusion criteria are;
- A maximum of three metastases to the lung from any non-haematological malignancy
- Tumour diameter ≤5cm
- ECOG 0 or 1
- Targets located away from central targets
- Primary and extrathoracic disease controlled with local therapy
Major exclusion criteria are;
- Previous high-dose thoracic radiotherapy in the region of proposed SABR
- Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment
- Concurrent targeted agents (such as sunitinib, bevacizumab and tarceva).
- Germ cell and small cell histologies
This study has accrued 29 participants. Open centres include Calvary Mater Newcastle, Liverpool Hospital, Peter MacCallum Cancer, Princess Alexandra Hospital, Royal Adelaide Hospital, Royal Hobart Hospital and Royal North Shore Hospital. 7 more sites across Australia, New Zealand and Denmark are expected to be activated in 2016.
The PLUNG-GP trial is a randomized Phase III trial comparing high dose palliative radiotherapy (HDPRT) with concurrent chemotherapy + HDPRT (C-HDPRT) in patients with good performance status, locally advanced or small volume metastatic NSCLC who are not suitable for radical chemo-radiotherapy, either due to tumour extent or patient factors. The optimal treatment approach for this group of patients is unknown and clinical practice varies throughout Australia. The PLUNG trial compares a widely employed high dose palliative radiotherapy regime (36Gy/12F) with a concurrent chemotherapy and high dose palliative radiotherapy regime (40Gy/20F + Vinorelbine + Cisplatin) which has been investigated in preceding Phase I and II trials conducted under the auspices of the Trans Tasman Radiation Oncology Group (TROG).
The objectives of the trial are to determine which regime is superior in terms of symptom relief and improvement in quality of life. The study aims to recruit 130 patients and has recently received a three year extension of funding from Cancer Australia. The study is open at PAH, Peter Mac, Townsville, Royal Brisbane, Calvary Mater Newcastle, Flinders Medical Centre, Allan Walker Centre Darwin, Liverpool, ROQ Gold Coast Hospital and Cairns with recruitment now at 55 patients.
CHISEL is now closed to accrual. This phase III trial is a TROG study endorsed and co-badged by ALTG. Patients with T1 and T2A N0 non-small cell lung cancer are randomised to hypofractionated stereotactic ablative radiotherapy (either 54 Gy in 3 fractions or 48 Gy in 4 fractions) versus conventionally fractionated radiotherapy 66 Gy in 33 fractions or 50 Gy in 20 fractions. Randomisation is 2 to 1 in favour of the experimental hypofractionated arm. The accrual phase was completed on the 22nd of June 2015, with 101 patients randomised. There are 18 participating sites: Princess Alexandra (29 patients), Peter Mac Moorabbin (10), Peter Mac East Melbourne (27), Alfred (3), Peter Mac Bendigo (2), Peter Mac Box Hill (3), RPAH (0), RNSH (0), Calvary Mater (0), Austin (3), Liverpool (5), Prince of Wales (0), Canberra (4), Royal Adelaide (1), Royal Hobart (2), Christchurch (8), Auckland (3) and Palmerston North (1). The trial is currently in follow-up phase and it will be completed in June 2017 with final analysis to follow.
Six serious adverse events have been reported to date including 3 events of exacerbation of COPD, bronchial infection, constipation, and Grade 3 dyspnoea, all of which are thought to be unrelated to the protocol therapy.
This trial has been funded by two grants through Cancer Australia’s Priority-driven Collaborative Cancer Research Scheme.
- Kron T, Clements N, Aarons Y, Dunn L, Chesson B, Miller J, Roozen, K, Ball, D. Radiochromic film for individual patient QA in extracranial stereotactic lung radiotherapy. Radiation 2011;46(12):1920-3.
- Clements N, Kron T, Franich R, Dunn L, Roxby P, Aarons Y, Siva S, Chesson B, Duplan D, Ball D. The effect of irregular breathing patterns on internal target volumes in four dimensional CT and cone-beam CT images in the context of stereotactic lung radiotherapy. Med Phys. 2013;40:021904.
- Siva, S., M. Shaw, B. Chesson, S. Gill and D. Ball (2012). “Analysis of the impact of chest wall constraints on eligibility for a randomized trial of stereotactic body radiotherapy of peripheral stage I non-small cell lung cancer.” J Med Imaging Radiat Oncol 2012; 56(6): 654-660.
Any further enquiries regarding this Trial should be directed to the principal investigator David Ball firstname.lastname@example.org or the central trial manager Janani Sivasuthan Janani.Sivasuthan@petermac.org