ACTRN12615000329561进行中(未招募)2 期
Double-blinded randomised trial of prophylactic dexamethasone versus placebo in stereotactic radiotherapy to 1-5 brain metastases, assessing symptomatology and quality of life.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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