Whole Brain Radiotherapy
Stage IV Melanoma, Intent of treatment: This study aims to improve the treatment of brain metastases for patients with stage IV melanoma by using WBRT to improve disease control, and maintain cognitive performance and quality of life.
Lead PI - Dr. Gerald Fogarty, St Vincents Hospital, Department of Radiation Oncology, phone: 02 9458 8000, email: Gerald.Fogarty@i-med.com.au.
Contact person – Maria Cronin, SMU North Sydney, phone: 02 9911 7302, email: maria.cronin@smu.org.au or Sandie Grierson at SMU North Sydney, phone: 02 9911 7301, email: sandie.grierson@smu.org.au. Sarah Gallagher at Calvary Mater Newcastle Hospital, phone: 02 49211182. Bronwyn Raymond or Florence Ko at Royal North Shore Hospital, phone: 02 9926 5050 or Libby Emmett or Dale Dalley at St. Vincent's Hospital Sydney, phone: 02 8382 2461 or 02 8382 3392.
IINCLUSION CRITERIA
- One to three (1-3) intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation. It will be assumed that the metastases are melanoma if the patient has documented histological or radiological concurrent extracranial disease that has already
- made the patient stage IV. If the cerebral lesion(s) is/are the first presentation of stage IV disease, then one metastasis must be histologically proven to be melanoma for the patient to be included in the study
- Completed localised treatment with neurosurgery and/or stereotactic irradiation of all melanoma brain metastases no more than 6 weeks prior to randomisation
- Life expectancy of at least 6 months. Aged 18 years or older
- An ECOG score of 2 or less at randomisation
- Able to provide written informed consent
- WBRT can begin within 8 weeks of localised treatment.
EXCLUSION CRITERIA
- Leptomeningeal disease on pre randomisation MRI
- Previous WBRT to the brain
- Patients who are pregnant
- Previous localised treatment (surgical excision or stereotactic treatment) for brain metastases prior to this diagnosis of cerebral melanoma
- Patients with prior cancers, except: those diagnosed more than five years ago with no evidence of disease recurrence within this time, and successfully treated basal cell and squamous cell skin carcinoma; and carcinoma in-situ of the cervix
- In order to be eligible for the main study, patients must meet all of the above inclusion and exclusion criteria.
- In addition, patients will be excluded from the neurocognitive and quality of life aspects of the study for any of the following reasons:
- A major active psychiatric disorder that would exclude patients from participating in the neurocognitive and quality of life assessments
- Fluency (oral and written) less than year 8 standard
