ACTRN12615000329561Active, not recruitingPhase 2
Double-blinded randomised trial of prophylactic dexamethasone versus placebo in stereotactic radiotherapy to 1-5 brain metastases, assessing symptomatology and quality of life.
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 64
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1Number of brain metastases – 1-5 brain metastases (as defined on the MRI brain); at least one lesion planned for SRT
- •2Non-primary brain tumour
- •3ECOG performance status 0-2
- •4Expected life expectancy of >6 months
- •5Not on dexamethasone for at least 7 days preceding treatment
- •6Willing or able to complete questionnaires by themselves
- •7Willing to be contacted by the study investigators in first 30 days following treatment for follow up
Exclusion Criteria
- •1More than 5 untreated brain metastases
- •2Leptomeningeal metastases
- •3Contraindications or comorbidities which may be seriously affected by dexamethasone – uncontrolled diabetes, previous psychosis secondary to dexamethasone
- •4Inability to complete MRI
- •5Planned cytotoxic chemotherapy during SRT
- •6Other tumour types – primary germ cell tumour, small cell carcinoma, haematological malignancies
- •7Brain metastases unsuitable for SRT (eg: located <2 mm of the optic chiasm)
- •8Pregnant or lactating women
- •9Men or women of childbearing potential who are unwilling to employ adequate contraception throughout study
Investigators
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