Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC
详细描述
The investigators will observe the time controlled by the brain lesion after the test and the total survival time of the patients. Meanwhile, during each follow-up, the investigators will extract cerebrospinal fluid for genomic analysis of cerebrospinal fluid
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC Brain metastasis
排除标准
- 未提供
研究组 & 干预措施
arm a
This group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study
干预措施: Placebos (Drug)
arm a
This group is a placebo control group, and we will use radiation therapy plus Placebos as the control group for the study
干预措施: radiotherapy (Radiation)
arm b
This group belongs to the experimental group. We will use radiotherapy combined with endostar for treatment, so as to judge the efficacy of the medicine
干预措施: endostar (Drug)
arm b
This group belongs to the experimental group. We will use radiotherapy combined with endostar for treatment, so as to judge the efficacy of the medicine
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From date of randomization until the date of first documented progression of brain lesions, and the maximum evaluation time is 36 months
the time from the start of treatment to the progression of the brain metastases, in months
次要结局
- Overall survival （OS）(From date of randomization until the date of death, assessed up to 36 months)
研究者
Xiaorong Dong
Clinical Professor
Wuhan Union Hospital, China