Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Large Brain Metastases: a Propensity-matched Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Local tumor control rate (LTCR)
研究概览
简要总结
A propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.
详细描述
A previous single arm phase II trial of our institution has shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control and overall survival rate was better than the results of a retrospective study using HFSRT alone in treating BMs of ≥ 3cm in diameter. Thus, we hypothesized that adding TMZ to HFSRT should translate to substantive benefits in clinical outcomes compared to HFSRT alone. Propensity score matching method was adopted to decrease potential bias in this retrospective study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) primary tumor was pathologically diagnosed and brain metastases were confirmed by gadolinium-enhanced magnetic resonance imaging (MRI) ; (2) age 18 years or older (3) KPS ≥60, or KPS ≥50 but symptomatically caused by BMs; (4) the large lesions haven't treated with surgery or SRT.
排除标准
- •(1) KPS <60 but not caused by BMs; (2) the large lesions have been treated with surgery or SRT.
结局指标
主要结局
Local tumor control rate (LTCR)
时间窗: 3 months after radiation
the control rate of treated lesions
次要结局
- Intracranial progression- free survival (IPFS)(up to 1 year)
- Local recurrence- free survival (LRFS)(up to 1 year)
- Overall survival (OS)(up to 3 years)
- Progression- free survival (PFS)(up to 1 year)
- Brain metastasis-specific survival (BMSS)(up to 1 year)
研究者
Jianping Xiao
Dr
Chinese Academy of Medical Sciences