Whole brain radiotherapy following local treatment of brain metastases in melanoma patients.

This randomised phase III trial aims to assess the value of treating brain metastases in patients with AJCC stage IV melanoma using adjuvant post-operative whole brain radiotherapy (WBRT) in the hope of improving disease control, and quality of life, while maintaining satisfactory cognition. The primary objective is to assess the effect of WBRT (after localised treatment for melanoma brain metastases) on distant intracranial control, as assessed by MRI scanning. From a health economics perspective the aim is to investigate the costs and effects of WBRT, and assess the impact of melanoma brain metastases on employment and household income. Utility-based quality of life of adults treated for melanoma brain metastases is calculated using European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) scores, and transforming them to utilities by using the new EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) instrument. This trial is an international, prospective multi-centre, open-label, phase III randomised controlled trial. Patients aged 18 years or older with 1-3 brain metastases excised and/or stereotactically irradiated and an Eastern Cooperative Oncology Group (ECOG) status of 0-2 are eligible. This trial aims to provide evidence that is currently lacking in treatment decision-making for patients with melanoma brain metastases.

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Melanoma Institute Australia, St Vincent’s Hospital, Mater Hospital, University of Sydney School of Public Health, Australia and New Zealand Melanoma Trials Group, Sydney Cancer Centre, University of Sydney Central Clinical School, Sir Charles Gairdner Hospital, Peter MacCallum Cancer Centre, University of Newcastle Research Centre for Gender, Health and Aging, Princess Alexandra Hospital, Trans-Tasman Radiation Oncology Group, Radium Hospital Norway, Oxford Clinical Trials Unit

Funded by:

NHMRC Cancer Australia project grants #512358 and #1009485

NSW Clinical Trials Partnership (Cancer Institute NSW and NHMRC Clinical Trials Centre)

Cancer Australia

Chief investigators:

Rachael L Morton, Janette Vardy, Haryana Dhillon, Gerald Fogarty, Anna Nowak, Catherine Mandel, Peta M Forder, Angela Hong, George Hruby, Bryan Burmeister, Brindha Shivalingam, John F Thompson

Trial registration number: