People with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. Depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised after local treatment of their brain metastases to either WBRT or observation. 220 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Calvary Mater Hospital
Newcastle, New South Wales, Australia
Genesis Cancer Care - Gateshead
Newcastle, New South Wales, Australia
Melanoma Institute Australia / Royal Prince Alfred Hospital
North Sydney, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Darwin Hospital, NT Radiation Oncology
Darwin, Northern Territory, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Radiation Oncology Services - Mater Centre
South Brisbane, Queensland, Australia
Townsville Hospital
Townsville, Queensland, Australia
...and 13 more locations
Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment
Time frame: 12 months post randomisation
Time to intracranial failure (local, distant and overall) as determined by MRI
Time frame: Post randomisation to intracranial failure
Quality of life as measured by EORTC QLQ-C30 and BN-20
Time frame: At baseline and every 2 months post randomisation
Neurocognitive function as measured by Hopkins Verbal Learning Test, Controlled Oral Word Association Test, Trail Making Test Part A & B, Stroop - Colour and Word Test and Digit Span (Forwards and Backwards).
Time frame: At baseline and every 2 months post randomisation
Overall survival
Time frame: Post randomisation to death from any cause
Performance status as measured by ECOG
Time frame: At baseline and every 2 months post randomisation
Incremental cost effectiveness ratio (ICER)
Time frame: At 12 months from randomisation
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