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ALTG Trials and Concepts in Development

  1. Concepts in development
  2. 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 cance
  3. 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
  4. 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)
  5. ALTG 13/004 OPAL: Online and Phone Assistance for Lung cancer (previously Helpline study)
  6. ALTG 13/003 Rekindle: testing an online resource to promote sexual wellbeing for both patients and their partners
  7. ALTG 13/002 Health related quality of life in Malignant Mesothelioma
  8. 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
  9. ALTG 10/001 PLUNG
  10. ALTG 09/005 TROG 09.02 CHISEL

Concepts in development

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 completed and a central ethics application was submitted in August, with anticipated approval late October and planned first patient in by Q1 2017

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. 14 sites
  • Feasibility completed, sites selected and informed
  • Protocol finalised and granted central ethics approval
  • Anticipated study start Q4 2016

ALTG 15/004 BR.34 – A phase III randomized trial of durvalumab ± tremelimumab in patients receiving pemtrexed-platinum combination chemotherapy for advanced (stage IIIb/IV) or metastatics non- squamous non-small cell lung cancer (NSCLC) CCTG – L Seymour (ALTG PI TBD)

  • The overall objective of this trial is to determine if durvalumab ± 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 300 globally
  • Ongoing discussions with CCTG re ALTG participation – likely to progress in 2017

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. 53
  • Initial approval for concept received from Bristol-Myers Squibb
  • Protocol development nearing completion

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
Austin Hospital Shane White 22 Jan 2016
Border Medical Oncology Craig Underhill
Campbelltown Hospital Po Yee Yip  16 Dec 2015
Canberra Hospital David Leong  14 Apr 2016
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 22 May 2016
Flinders Medical Centre Anand Rose  29 July 2016
Liverpool Hospital Victoria Bray  2 Dec 2015
Mater Adult Hospital Brisbane Felicity Murphy (Maternity Leave)

Vikram Jain

2 Dec 2015 2
Monash Medical Centre Peter Briggs 24 Aug 2016
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 Vinod Ganju  2 Mar 2016
Prince Charles Hospital Brett Hughes  8 Oct 2015
Princess Alexandra Hospital Ken O’Byrne 10 Sep 2015 2
Royal Adelaide Hospital Michael Brown 30 July 2015 2
Royal Hobart Hospital Louise Nott  28 Oct 2015
Royal Melbourne Hospital, Parkville 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  17 June 2016

Study Contacts

Study Chair: Sue-Anne McLachlan sue-anne.mcLachlan@svha.org.au

CTC Trial Coordinator: Hannora Jurkovic BR.31@ctc.usyd.edu.au

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 October 2016.

Site Name Principal Investigator Est. Recruitment
The Alfred Hospital Maggie Moore 15
Auckland City Hospital George Laking 6
Austin Hospital Paul Mitchell 18
Chris O’Brien Lifehouse Steven Kao 10
Flinders Medical Centre Chris Karapetis 15
Genesis Cancer Care Kenneth O’Byrne 6
Nambour General Hospital Kathleen Houston 6
Peninsula South Eastern Haematology & Oncology Group Vinod Ganju 6
Prince of Wales Hospital Craig Lewis 8
Princess Alexandra Hospital Kenneth O’Byrne 20
Royal Adelaide Hospital Hien Le 10
Royal Brisbane and Women’s Hospital Brett Hughes 10
Royal Hobart Hospital Louise Nott 6
Royal North Shore Hospital Nick Pavlakis 10
Sir Charles Gairdner Hospital Arman Hasani 4
St Vincent’s Hospital Sue-Anne McLachlan 6
Sydney Adventist Hospital Csilla Hasovits 5
Townsville Hospital Suresh Varma 10
The Tweed Hospital Ehtesham Abdi 8
Western Health Sunshine/ Western Health Lung Oncology (Footscray) Shankar Siva 10

Study Contacts

Study Chair: Paul Mitchell (paul.mitchell@austin.org.au)

CTC Trial Coordinator: Annie Yeung (nivorad@ctc.usyd.edu.au)

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. A consumer meeting regarding the design and implementation of the consumer survey has recently been held. The DCE survey is being prepared and will be rolled out soon.

This study aims to recruit 72 participants over 3 years and the protocol is still under development.

Study contacts

Trial Chair: Dr Fiona Hegi-Johnson (fionahegi@gmail.com)
Trial Co-ordinator: Angie Chung, TROG Cancer Research (SABR-OS@trog.com.au)

ALTG 13/004 OPAL: Online and Phone Assistance in Lung cancer (previously Helpline study)

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.

Patient recruitment has continued to track lower than was anticipated, however has continued to progress at a steady rate. Our site recruitment number recently reached 49 sites (note: 48 sites have ethical approval and are currently recruiting or will commence recruiting soon; the remaining site is 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, WA and SA. 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, Toowoomba Hospital and Nambour 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, Queen Elizabeth Hospital and Royal Adelaide Hospital.

To date we have recruited 291 participants to the trial. Participant withdrawal has been a continual challenge, attributable to the difficulties in recruiting from the lung cancer patient population.

Cancer Council NSW consultants continue to deliver information, support and assistance to participants (via letters, outbound phone calls and web chats/email support). 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 protocol paper for the study, titled Protocol for a randomised controlled trial of proactive Web-based versus telephone-based information and support: Can electronic platforms deliver effective care for lung cancer patients?, is currently undergoing copy editing and has been accepted for publication in JMIR Research Protocols.

A systematic review, titled Techniques for Improving Communication of Emotional Content in Text-only Online Therapeutic Communications – A Systematic Review, is currently being considered by a peer-reviewed journal.

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

July 2016 update: 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 douglas.williams@sydney.edu.au

ALTG 13/002 Health related quality of life in Malignant Mesothelioma

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.

The project received ethical approval under the multi-site approval process in August 2013. Site-specific ethics approval has been received for 15 sites across NSW, QLD, VIC and SA. To date, 84 participants have been recruited with 34 currently active on the study. Twenty-seven participants have deceased, 16 have withdrawn (primarily due to disease progression) and 7 participants have completed their 2-year involvement in the study. Recruitment rates at each site are listed below.

Concord Hospital 3
ADRI 23
Northern Cancer Institute 6
Prince of Wales Hospital 2
Royal Prince Alfred Hospital 0
Westmead Hospital 4
The Prince Charles Hospital 16
Strathfield Private Hospital 0
Central West Cancer Service, Orange Health Service 6
Macarthur Cancer Therapy Centre, Campbelltown Hospital 2
Liverpool Hospital 5
Alan Coates Cancer Centre, Dubbo Base Hospital 0
Flinders Medical Centre 1
Chris O’Brien LifeHouse 15
Austin Health 1

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.

Study contacts

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 jason.fowler@sydney.edu.au

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 37 participants. Open centres include Calvary Mater Newcastle, Campbelltown Hospital, Canberra Hospital, Liverpool Hospital, Peter MacCallum Cancer Centre, Prince of Wales Hospital, Princess Alexandra Hospital, Royal Adelaide Hospital, Royal Hobart Hospital and Royal North Shore Hospital.

Publications

  1. Pham D, Hardcastle N, Foroudi F, Kron T, Bressel M, Hilder B, Chesson B, Oates R, Montgomery R, Ball D, Siva S. A Multidisciplinary Evaluation of a Web-based eLearning Training Programme for SAFRON II (TROG 13.01): A Multicentre Randomised Study of Stereotactic Radiotherapy for Lung Metastases. Clin Oncol. 2016
  2. Siva S, Kron T, Bressel M, Haas M, Mai T, Vinod S, Sasso G, Wong W, Le H, Eade T, Hardcastle N, Chesson B, Pham D, Høyer M, Montgomery R, Ball D. A Randomised Phase II Trial of Stereotactic Ablative Fractionated Radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the Lung (TROG 13.01 SAFRON II). BMC Cancer. 2016 Mar: 16:183

Study Contacts
Trial Chair: Dr Shankar Siva, Peter MacCallum Cancer Centre shankar.siva@petermac.org
Trial Co-ordinator: Rebecca Montgomery, TROG Cancer Research SAFRONII@trog.com.au

ALTG 10/001 PLUNG

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 MacCallum Cancer Centre, Townsville, Royal Brisbane, Calvary Mater Newcastle, Flinders Medical Centre, Allan Walker Centre Darwin, Liverpool, ROQ Gold Coast Hospital, Cairns and St George Hospital with recruitment now at 59 patients.

For anyone who is interested in this study please contact either Dr Margot Lehman (margot.lehman@health.qld.gov.au) or A/Prof Michael Michael (michael.michael@petermac.org)

ALTG 09/005 TROG 09.02 CHISEL

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.

Publications

  1. 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.
  2. 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.
  3. 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 (david.ball@petermac.org) or the central trial manager Janani Sivasuthan (janani.sivasuthan@petermac.org)