Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial

Inclusion Criteria:

- 1-3 intracranial metastases on MRI from melanoma, locally treated with either
surgical excision and/or stereotactic irradiation.

- Life expectancy of at least 6 months

- Aged 18 years or older

- WBRT must begin within 8 weeks of completion of localised treatment and within 4
weeks of randomisation

- Able to have an MRI brain scan with contrast. Estimated Glomerular Filtrate Rate
(eGFR) is adequate at the discretion of the radiologist and capable of having
gadolinium-containing contrast medium for MRI as per practice guidelines

- Complete localised treatment of all these metastases no more than 6 weeks prior to
randomisation

- An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at
randomisation

- CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must
be within 12 weeks of randomisation

- Serum Lactate Dehydrogenase (LDH) must be = or < 2 x upper limit of normal

- Able to provide written informed consent

Exclusion Criteria:

- Any untreated intracranial disease

- Any previous intracranial treatment (surgical excision and/or stereotactic
irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma

- Evidence of leptomeningeal disease on pre-local treatment MRI scan

- Patients with prior cancers, except:

- Those diagnosed more than five years ago with no evidence of disease recurrence
within this time;

- Successfully treated basal cell and squamous cell skin carcinoma;

- Carcinoma in-situ of the cervix

- A medical or psychiatric condition that compromises ability to give informed consent
or complete the protocol

- Positive urine pregnancy test for women of childbearing potential within a week of
registration onto the trial