A Single Center, Open Label, Multicenter Study to Determine the Safety and Efficacy of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Objective response rate of intracranial lesions
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of icotinib in combination with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is objective response rate of intracranial lesions.
详细描述
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with multiple brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. This study is designed to evaluate the safety and efficacy of icotinib combined with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is intracranial objective response rate .
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmation of non-small-cell lung cancer (NSCLC).
- •Diagnosis of non-systematic brain metastases on a Gadolinium-enhanced MRI. More than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
- •No other metastases except for brain metastases.
排除标准
- •Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- •CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
研究组 & 干预措施
Icotinib plus WBRT
Standard whole brain radiotherapy is given with 4000cGY/20 times, plus concurrent icotinib, which was administered orally three times per day.
干预措施: Icotinib plus WBRT (Drug)
结局指标
主要结局
Objective response rate of intracranial lesions
时间窗: 8 weeks
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
次要结局
- Objective response rate of extracranial lesions(8 weeks)
- Progression-free survival of intracranial lesions(3-6 months)
- Safety and tolerability(6-12 months)