Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/30899
Title: Multi-Arm GlioblastoMa Australasia (MAGMA): protocol for a multiarm randomised clinical trial for people affected by glioblastoma.
Austin Authors: Kong, Benjamin Y;Sim, Hao-Wen;Barnes, Elizabeth H;Nowak, Anna K;Hovey, Elizabeth J;Jeffree, Rosalind;Harrup, Rosemary;Parkinson, Jonathon;Gan, Hui K ;Pinkham, Mark B;Yip, Sonia;Hall, Merryn;Tu, Emily;Carter, Candace;Koh, Eng-Siew;Lwin, Zarnie;Dowling, Anthony;Simes, John S;Gedye, Craig
Affiliation: Hunter Medical Research Institute, New Lambton, New South Wales, Australia
Collaboration for Cancer Outcomes, Research and Evaluation, Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia
Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
School of Medicine, University of Queensland, Brisbane, Queensland, Australia
Department of Medical Oncology, St Vincent's Hospital Melbourne Pty Ltd, Fitzroy, Victoria, Australia
Department of Medical Oncology, Calvary Mater Newcastle, Waratah, New South Wales, Australia
NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia ben.kong@sydney.edu.au.. Department of Medical Oncology, Royal North Shore Hospital, St Leonards, New South Wales, Australia
NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia
St Vincent's Clinical School, University of New South Wales, Sydney, New South Wales, Australia
Department of Medical Oncology, The Kinghorn Cancer Centre, Darlinghurst, NSW, Australia
Department of Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Medical School, The University of Western Australia, Crawley, Western Australia, Australia
Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Perth, Australia
Department of Medical Oncology, Nelune Comprehensive Cancer Centre, Prince of Wales Hospital, Randwick, New South Wales, Australia
Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
Department of Neurosurgery, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Cancer and Blood Services, Royal Hobart Hospital, Hobart, Tasmania, Australia
Department of Neurosurgery, Royal North Shore Hospital, St Leonards, New South Wales, Australia
Olivia Newton-John Cancer Research Institute
School of Cancer Medicine, La Trobe University, Melbourne, Victoria, Australia
Department of Medicine, University of Melbourne Victorian Comprehensive Cancer Centre, Parkville, Victoria, Australia
Medical Oncology
Department of Radiation Oncology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
School of Clinical Sciences, Queensland University of Technology, Brisbane, Queensland, Australia
Radiation Oncology, Liverpool Cancer Therapy Centre, Liverpool, New South Wales, Australia
Issue Date: 14-Sep-2022
metadata.dc.date: 2022
Publication information: BMJ open 2022; 12(9): e058107
Abstract: Glioblastoma (GBM) is the most common malignant primary central nervous system cancer in adults. The objective of the Multi-Arm GlioblastoMa Australasia (MAGMA) trial is to test hypotheses in real world setting to improve survival of people with GBM. Initial experimental arms are evaluating the effectiveness of interventions in newly diagnosed GBM (ndGBM). This study will compare maximal surgical resection followed by chemoradiotherapy plus adjuvant chemotherapy for 6 months with the addition of (1) 'neoadjuvant' chemotherapy beginning as soon as possible after surgery and/or (2) adjuvant chemotherapy continued until progression within the same study platform. MAGMA will establish a platform for open-label, multiarm, multicentre randomised controlled testing of treatments for GBM. The study began recruiting in September 2020 and recruitment to the initial two interventions in MAGMA is expected to continue until September 2023.Adults aged ≥18 years with ndGBM will be given the option of undergoing randomisation to each study intervention separately, thereby giving rise to a partial factorial design, with two separate randomisation time points, one for neoadjuvant therapy and one for extended therapy. Patients will have the option of being randomised at each time point or continuing on with standard treatment.The primary outcome for the study is overall survival from the date of initial surgery until death from any cause. Secondary outcomes include progression-free survival, time to first non-temozolomide treatment, overall survival from each treatment randomisation, clinically significant toxicity as measured by grade 3 or 4 adverse events and health-related quality-of-life measures. Tertiary outcomes are predictive/prognostic biomarkers and health utilities and incremental cost-effectiveness ratio.The primary analysis of overall survival will be performed separately for each study intervention according to the intention to treat principle on all patients randomised to each study intervention. The study (Protocol version 2.0 dated 23 November 2020) was approved by a lead Human Research Ethics Committee (Sydney Local Health District: 2019/ETH13297). The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. ACTRN12620000048987.
URI: https://ahro.austin.org.au/austinjspui/handle/1/30899
DOI: 10.1136/bmjopen-2021-058107
ORCID: http://orcid.org/0000-0001-8659-5591
http://orcid.org/0000-0002-2530-0523
http://orcid.org/0000-0001-7663-2694
Journal: BMJ open
PubMed URL: 36104135
Type: Journal Article
Subjects: Adult oncology
Magnetic resonance imaging
Neurological oncology
Appears in Collections:Journal articles

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