Location: Melanoma Institute Australia North Sydney/ RPAH
Trial status: Open
Treatment type: Radiation Therapy
Stage: IV
Intent of treatment:
Title: Whole Brain Radiotherapy following local treatment of intracranial metastases of melanoma – A randomized phase III trial.
Target population: 200 patients with melanoma who have had 1-3 brain metastases excised and/or stereotactically irradiated. To be eligible patients must have an ECOG performance status of two or better at randomisation. Patients with leptomeningeal disease, or who have had previous WBRT or localised treatment for cerebral malignancy will not be eligible.
Intracranial metastases are common in melanoma. These can be treated with surgery, however the role of whole brain radiotherapy (WBRT) after local treatment is controversial.
This is a multi-centre randomized controlled trial of patients with 1-3 intracranial melanoma metastases. Patients will be randomized to receive either WBRT or observation only following surgery and/or stereotactic irradiation. Patients on the observation arm can receive WBRT at the point of recurrence at the discretion of the treating clinician.
The trial will assess the effects of WBRT on distant intracranial control, quality of life, neurocognition, and survival.
The trial aims to recruit 200 patients over 4 years and is led by the Australia and New Zealand Melanoma Trials Group (ANZMTG) in collaboration with the Trans-Tasman Radiation Oncology Group (TROG), Sydney Neuro-Oncology Group (SNOG) and the NHMRC Clinical Trials Centre (CTC).
Following establishment of the trial within Australia, it is planned that the trial will also be run internationally, pending accrual and interest.
Contacts
Principal Investigator: Dr. Angela Hong
Study Coordinator: Maria Gonzalez: +61 2 9911 7300
Study Coordinator: Maria Synnott: +61 2 9911 7306
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