NCT05588206招募中1 期
Dose-escalation by Hypofractionated Stereotactic Radiotherapy Simultaneous Integrated Boost IMRT for Brain Metastases in Non Small Cell Lung Cancer：A Phase I Study
First People's Hospital of Hangzhou1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- MTD
研究概览
简要总结
The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.
详细描述
The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histology confirmed that it was non-small cell lung cancer
- •1 to 10 brain metastases detected by magnetic resonance imaging (MRI)
- •A life expectancy of >3 months according to the DS GPA.
- •Control of the primary lesions (thorax) at the time of SBRT
- •2cm<Tumor size ≤ 4 cm
- •Age of 18-75 years old
- •Patients must be able to undergo contrast enhanced MRI for planning
- •Adequate bone marrow and organ function
排除标准
- •other malignant tumors
- •Prior surgery to brain metastasis
- •Prior brain radiotherapy
- •Non-small cell lung cancer with more than 10 brain metastases detected by MRI
- •Contraindication to receiving radiotherapy.
结局指标
主要结局
MTD
时间窗: 1 years
maximum tolerated dose
次要结局
- ARE(2 years)
- iPFS(2 years)
- OS(2 years)
研究者
研究点 (1)
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