A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
试验速览
- 阶段
- 2 期
- 入组人数
- 162
- 主要终点
- Progression-free survival of intracranial lesions
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS 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 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. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.
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 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) with brain metastases
- •Histological or cytological confirmation of EGRF positive sensitive mutation
- •Diagnosis of brain metastases on a Gadolinium-enhanced MRI
排除标准
- •Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux
- •Previous usage of radiation with brain
- •CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
研究组 & 干预措施
Icotinib
icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(>3 with WBRT or <=3 with SRS) after PD
干预措施: Icotinib (Drug)
Icotinib plus radiation therapy
Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(>3), or SRS(<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses.
干预措施: Icotinib (Drug)
Icotinib plus radiation therapy
Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(>3), or SRS(<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses.
干预措施: WBRT or SRS (Radiation)
结局指标
主要结局
Progression-free survival of intracranial lesions
时间窗: 10 months
Number of participants with progress of intracranial lesions
次要结局
- Progression-free survival(8 months)
- Objective response rate of intracranial lesions(8 weeks)