An interventional study of WBRT in Metastatic Melanoma, sponsored by Melanoma and Skin Cancer Trials Limited. Status unknown at 23 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-07.
Sponsored by Melanoma and Skin Cancer Trials Limited · Not applicable, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 220 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Melanoma and Skin Cancer Trials Limited is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with prior cancers, except:
Patients will receive WBRT after local treatment. A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
Radiation: WBRT
No Intervention
A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
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
Plan to share: No
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Melanoma and Skin Cancer Trials Limited