None listed
Conditions
Brief summary
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. 200 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.
Interventions
Whole brain radiotherapy - a minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
Sponsors
Melanoma and Skin Cancer (MASC) Trials
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation. 2. Life expectancy of at least 6 months 3. Aged 18 years or older 4. WBRT must be within 8 weeks of completion of localised treatment and within 4 weeks of randomisation 5. 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 6. Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation 7. An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation 8. CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation 9. Serum Lactate Dehydrogenase (LDH) must be = or < 2 x upper limit of normal 10. Able to provide written informed consent
Exclusion criteria
1. Any untreated intracranial disease 2. Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma 3. Evidence of leptomeningeal disease on pre-local treatment MRI scan 4. Patients with prior cancers, except: o Those diagnosed more than five years ago with no evidence of disease recurrence within this time; o Successfully treated basal cell and squamous cell skin carcinoma; o Carcinoma in-situ of the cervix 5. A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol 6. Positive urine pregnancy test for women of childbearing potential within a week of registration onto the trial
Outcome results
None listed