ACTRN12615000689572终止2 期
Randomised trial of adjuvant versus delayed stereotactic radiotherapy to resection cavity of brain metastases and quality of life outcomes
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
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
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Age >/=18 years
- •2 Number of brain metastases – 1-4 brain metastases (as defined on the pre-operative MRI brain) and complete resection of the lesions on post-operative imaging performed within 4 weeks of surgery
- •3 Non-primary brain tumour site
- •4 ECOG performance status 0-3
- •5 Expected life expectancy of >6 months
- •6 Size of each resection cavity – resection cavity must measure < /=5.0 cm in maximal extent on the post-operative MRI obtained within 4 weeks post-surgery.
- •7 Tumour staging procedures – all standard tumour-staging procedures necessary to define baseline extra-cranial disease status completed < /=42 days prior to registration
- •8 Willing or able to complete health-related questionnaires by themselves and by a carer/proxy, if available
- •9 Willing and able to complete neurocognitive assessments
排除标准
- •1 More than 4 untreated brain metastases
- •2 Prior cranial radiation therapy
- •3 Leptomeningeal metastases
- •4 Inability to complete MRI brain
- •5 Known allergy to gadolinium
- •6 Remaining unresected brain metastases
- •7 Planned cytotoxic chemotherapy during stereotactic radiotherapy (SRT)
- •8 Other tumour types – primary germ cell tumour, small cell carcinoma, or lymphoma
- •9 Resected cavities unsuitable for SRT (eg. located < /= 2 mm from the optic chiasm)
- •10 Pregnant or lactating women
- •11 Men or women of childbearing potential who are unwilling to employ adequate contraception throughout study
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