跳至主要内容
临床试验/ACTRN12615000329561
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.

William Buckland Radiotherapy Centre0 个研究点目标入组 64 人开始时间: 2015年4月10日最近更新:
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

相似试验