ALTG Trial Updates
- 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 14/001 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 12/003 Chemotherapy Utilisation for Malignant Mesothelioma (CUMM)
- ALTG 10/001 PLUNG
- ALTG 09/005 TROG 09.02 CHISEL
- ALTG 08/001 PAL study (Physical Activity in Lung)
- ALTG 06/003 NITRO: A phase III, multi-centre randomised trial of adding nitroglycerin to first line chemotherapy for advanced non-small cell lung cancer
- ALTG 04/009 PACT in NSCLC
ALTG 13/008 Investigating the impact of early palliative care (J Yoong, L Milleshkin)
- 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
- Project grant resubmitted to CA in 2015. Result pending Q4 2015
ALTG 14/002 Phase II placebo-controlled randomised study of nivolumab +/- RT in the treatment of advanced NSCLC (P Mitchell, K O’Byrne, S Siva)
- 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
- Planned sample size 120 at approx. 25 ANZ sites
- Budget & protocol are being finalised. Ethics submission estimated November 2015
ALTG 14/003 Phase II trial of MEDI4736 & nab-paclitaxel as 2nd line chemotherapy in advanced MPM (S Kao)
- A trial to determine the activity and safety of MEDI4736 alone, nab-paclitaxel alone, and the combination of nab-paclitaxel and MEDI4736 as 2nd line chemotherapy for MPM
- Planned sample size 90 at approx. 35 sites (25 ANZ + 10 Canada)
- Concept submitted to company for consideration
TBA Randomised phase II study of switch maintenance nab-paclitaxel plus BSC vs BSC alone in extensive-stage small-cell lung cancer non-progressive after initial platinum-based chemotherapy (P Mitchell, N Pavlakis)
- Planned sample size 147; concept in development
TBA Phase III open label randomised trial of adjuvant cisplatin/nab-paclitaxel, adjuvant immunotherapy or both versus observation following resection of stage I solid or micropapillary predominant adenocarcinoma of the lung (T Clay, K O’Byrne, N Pavlakis)
- A trial to determine the efficacy of adjuvant chemotherapy with cisplatin and nab-paclitaxel, adjuvant immunotherapy or both following resection of stage I solid or micropapillary predominant lung adenocarcinoma
- Planned sample size approx. 1200; concept in development
TBA MEDI4736 and chemotherapy in mesothelioma (A Nowak, J Lesterhuis, M Millward, B Robinson, R Lake)
- To determine the 6 month PFS, safety and tolerability of MEDI4736 in combination with cisplatin and pemetrexed in MPM planned for 1st line chemo
- Planned sample size 54 at approx.12 sites
- Concept submitted to company for consideration
TBA Pembrolizumab for 1st line treatment of mesothelioma (NCIC – L Seymour)
- A trial to evaluate whether pembrolizumab, single agent or added to standard chemotherapy, improves progression free survival in mesothelioma
- Planned sample size 126 (50 from ANZ); concept 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)
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) and a grant application was submitted to the NHMRC and funding partners in March 2015. 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 is currently under development and aims to start the 3 year recruitment phase of 72 participants in April 2016.
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|
|Austin Hospital||Shane White|
|Campbelltown Hospital||Po Yee Yip|
|Canberra Hospital||David Leong|
|Canterbury Regional Cancer and Haematology Service||David Gibbs|
|Central Coast Cancer Centre||Matthew Chan||Planned Oct2015|
|Chris O’Brien Lifehouse||Steven Kao|
|Coffs Harbour Health Campus – NCCI||Karen Briscoe||24-Jul-15|
|Epworth Richmond Hospital||Ross Jennens||22-Jul-15|
|Fiona Stanley Hospital||Andrew Davidson|
|Flinders Medical Centre||Anand Rose|
|Liverpool Hospital||Victoria Bray|
|Mater Adult Hospital Brisbane||Felicity Murphy||Planned Oct2015|
|Monash Medical Centre||Peter Briggs|
|Nambour General Hospital||Kathleen Houston (Maternity Leave)
|Nepean Cancer Care Centre||Catherine Crombie||Planned Oct2015|
|Northern Cancer Institute St Leonards||Nick Pavlakis||17-Jul-15|
|Peninsula Oncology Centre, Frankston, Victoria||Vinod Ganju|
|Prince Charles Hospital||Brett Hughes||Planned Oct2015|
|Princess Alexandra Hospital||Ken O’Byrne||10-Sep-15|
|Royal Adelaide Hospital||Michael Brown||30-Jul-15|
|Royal Hobart Hospital||Louise Nott|
|Royal Melbourne Hospital, Parkville, Victoria, Australia||Richard de Boer||18-Aug-15|
|Sir Charles Gairdner Hospital||Michael Millward||Planned Sep2015|
|St George Hospital||Chee Lee|
|St Vincent’s Hospital Melbourne including St Vincent’s Private Hospital||Sue-Anne McLachlan
ANZ Study Chair
|Westmead Hospital||Rina Hui|
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. Site-specific ethics approval has been received for 20 hospital sites across NSW, QLD and VIC (Calvary Mater Newcastle, Campbelltown, Cameron Oncology, Coffs Harbour, Concord, Epworth Richmond, Geelong, Illawarra, Liverpool, Manning/Taree, Mildura, Monash Clayton, Monash Moorabbin, Rockhampton, Royal Hobart, South West Oncology Warnambool, Southern Highlands Bowral, St Vincents, Tamworth, Tweed Heads/Murwillumbah) with a further 10 sites in process. To date, 55 participants are enrolled in the study (7 participants have deceased, 14 have withdrawn). As of August 2015, Cancer Council NSW consultants have delivered information, support and assistance to 26 participants (10 letters, 15 phone calls, 1 web chat). The phone calls vary from 1 minute to 20 minutes. The webchat was 20 minutes in length. The study is expected to continue for another 12-15 months.
The study is supported by funding received from the National Health and Medical Research Council and the Cancer Council NSW. The study received ALTG endorsement.
For any further information please contact Principal Investigator A/Prof Christine Paul (email@example.com)
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.
Rekindle is a randomised control trial that aims to determine which modality of Rekindle is most feasible and encourages greater completion of the prescribed intervention, and demonstrate the efficacy of Rekindle to improve sexual satisfaction. Participants are randomised into three conditions: Rekindle, Rekindle Plus (Rekindle plus three phone calls), and the Attention Control condition.
At 1 July 2015 166 participants had been recruited via 30 sites nationally and Cancer Council NSW supportive care activities. The overall recruitment target is 500.
For information or to request materials, contact Amelia Beaumont, Rekindle Project Manager, at firstname.lastname@example.org
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 approval at another 3 sites pending. To date, 60 participants have been recruited with 44 currently active on the study (12 participants have deceased, 4 have withdrawn).
|Northern Cancer Institute||6|
|Prince of Wales Hospital||1|
|Royal Prince Alfred Hospital||0|
|The Prince Charles Hospital||12|
|Strathfield Private Hospital||0|
|Central West Cancer Service, Orange Health Service||2|
|Macarthur Cancer Therapy Centre, Campbelltown Hospital||0|
|Alan Coates Cancer Centre, Dubbo Base Hospital||0|
|Flinders Medical Centre||0|
|Chris O’Brien LifeHouse||10|
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 is a Trans-Tasman Radiation Oncology Group (TROG) lead trial conducted in co-operation with the Australasian Lung Cancer Trials Group (ALTG).
Stereotactic Ablative Body Radiotherapy (SABR) is an emerging radiotherapy technique that is delivered over very few sessions. It is non-invasive and associated with high rates of tumour control and relatively low toxicity for patients with limited metastatic disease to the lung. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments.
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 pretreatment 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 opened in January 2015 and has accrued 16 participants. Open centres include Calvary Mater Newcastle, Liverpool Hospital, Peter MacCallum Cancer, Princess Alexandra Hospital and Royal Adelaide Hospital. Austin Health, Barwon Health, Campbelltown Hospital, Prince of Wales Hospital and Royal Hobart Hospital are all expected to be activated by the end of 2015.
Trial Chair: Dr Shankar Siva, Peter MacCallum Cancer Centre (firstname.lastname@example.org)
Trial Co-ordinator: Rebecca Montgomery, TROG Cancer Research (SAFRONII@trog.com.au)
Stage 1 of this study demonstrated that the rate of chemotherapy uptake amongst people diagnosed with malignant pleural mesothelioma (MPM) is around 54%, whereas evidence-based guidelines for MPM suggest the optimal rate of chemotherapy utilisation should be around 65%. The aim of this study was to explore the reasons for this difference in chemotherapy use.
Stage 2 of the study involved interviewing 70 people about their views on chemotherapy use and treatment decision-making across patients, caregivers, nurses and a range of medical specialties.
These interviews identified a range of potential barriers to accessing chemotherapy. The results were used to develop quantitative questionnaires (Stage 3) for patients, caregivers, doctors, and nurses which investigated management of MPM on a broad scope. An online version of the survey was available for participants to complete or they could nominate to have a hard copy of it mailed to them with a reply-paid envelope. Patient and caregiver participants were recruited through the Dust Diseases Board NSW, mesothelioma support groups, clinicians treating MPM patients and other groups involved with mesothelioma. Healthcare professionals treating patients with MPM were invited to complete the questionnaire through professional organisations and specialist colleges.
Data were collected from January to September 2014. Surveys were completed by:
- 78 people with MPM;
- 106 caregivers;
- 107 doctors (53 Respiratory Physicians, 37 Medical Oncologists, 7 Radiation Oncologist, 3 Palliative Care Physicians, 3 Thoracic Surgeons and 4 “Other”); and
- 19 specialist nurses.
The data are currently being analysed and the results from the study will be presented at conferences over the coming months. A publication is also currently being prepared.
We are very grateful to the ALTG for the strong level of support they have provided to the study and we would like to thank all the ALTG members who participated in the project by giving their time to be interviewed and/or completing the survey.
Investigators: Dr Steven Kao, A/Prof. Janette Vardy, Dr Haryana Dhillon, Dr Prunella Blinman
Study Coordinator: Ms Anne Warby (email@example.com)
- A Warby, H Dhillon, S Kao, J Vardy. Chemotherapy for malignant mesothelioma: patient, caregiver and health professionals’ perceptions of treatment and what influences access. (Poster) Cancer Institute NSW Innovations in Cancer Services & Care Conference, Sydney, August 2013
- H Dhillon, A Warby, S Kao, J Vardy. Chemotherapy for malignant mesothelioma: patient, caregiver and health professionals’ perceptions of treatment and what influences access. (Poster) IALSC World Conference on Lung Cancer, Sydney, October 2013. J Thorac Oncol 2013; 8(Suppl. 2): S1240
- A Tognela, S Kao, N Van Zandwijk, S Clarke, J Vardy, V Bray, S Lumba, W. Ng. Estimation of an optimal chemotherapy utilisation rate for malignant pleural mesothelioma: an evidence-based benchmark for patient care. (Poster) IALSC World Conference on Lung Cancer, Sydney, October 2013. J Thorac Oncol 2013; 8(Suppl. 2): S642-S643
- MA Malalasekera, HM Dhillon, A Warby, SC Kao, JL Vardy. “Mortally wounded”: stakeholder perceptions of the Malignant Pleural Mesothelioma diagnostic process. (Poster presentation) Australian Lung Cancer Conference, Brisbane, October 2014
- HM Dhillon, SC Kao, A Warby, JL Vardy. Healthcare professional perceptions regarding chemotherapy use in treatment of Malignant Pleural Mesothelioma (MPM): quantitative survey results. (Oral presentation) Australian Lung Cancer Conference, Brisbane, October 2014
- JM Fowler,HM Dhillon,J Shaw,A Warby,J Coll,S Kao,J Vardy. Mesothelioma from the Patient’s Perspective: Quality of Life and Lived Experience in people with MPM. (Invited presentation). Clinical Oncology Society of Australia ASM, Melbourne, December 2014. Asia-Pac J Clin Oncol 2014; 10(Suppl. 8): 111
- A Warby, SC Kao, HM Dhillon, JL Vardy. Healthcare professional perceptions regarding chemotherapy use in treatment of Malignant Pleural Mesothelioma (MPM): quantitative survey results. (Poster) Cancer Institute NSW Innovations in Cancer Treatment & Care Conference, Sydney, October 2014
- MA Malalasekera, HM Dhillon, A Warby, SC Kao, JL Vardy. “Mortally wounded”: stakeholder perceptions of the Malignant Pleural Mesothelioma diagnostic process. (Poster presentation) International Mesothelioma Interest Group Conference, Cape Town, October 2014
- S Kao, H Dhillon, A Warby, J Vardy. Healthcare Professional Perceptions of Chemotherapy in Treatment of Malignant Pleural Mesothelioma (MPM). (Poster presentation) IASLC 16th World Conference on Lung Cancer, Denver, September 2015
- SCH Kao, N van Zandwijk, S Clarke, J Vardy, S Lumba, A Tognela, W Ng. Estimation of an optimal chemotherapy utilisation rate for malignant pleural mesothelioma: An evidence-based benchmark for cancer care. Asia Pac J Clin Oncol. 2015; 11:85-92. DOI: 10.1111/ajco.12306
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, Newcastle, Flinders Medical Centre and the Gold Coast Hospital with recruitment now at 37 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 randomized 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).
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 Measurements. 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 fourdimensional 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, at firstname.lastname@example.org or the central trial coordinator, Marijana Vanevski at email@example.com
The PAL study is a randomised control trial which aims to evaluate the effects of a structured physical activity program on fatigue and quality of life for people with non-resectable lung cancer (NSCLC, SCLC). Participants are randomised to either the usual standard of care or a 2-month physical activity programme, which consists of a combination of homebased and supervised exercise sessions. The supervised sessions also include a behavioural change component to help promote the importance, benefits and maintenance of physical activity.
This study is now complete with 112 randomised participants. Results were presented at the 2015 ASCO Meeting and publications are currently in process.
A/Prof Janette Vardy (PI) Janette.firstname.lastname@example.org
Dr Haryana Dhillon (PI) Haryana.email@example.com
Ms Jane Turner (Study Coordinator) firstname.lastname@example.org
ALTG 06/003 NITRO: A phase III, multi-centre randomised trial of adding nitroglycerin to first line chemotherapy for advanced non-small cell lung cancer
Participant follow up ceased on 31st December 2014 and the final analysis was performed in early 2015. The final results have been accepted for publication in Annals of Oncology, November 2015 issue and are now available on the Annals of Oncology website.
This study was closed in October 2013. Results were published in the European Journal of Cancer (2015) 51:1529-1537