A Phase II Study of Erlotinib in Benefitted Patients With Asymptomatic Brain Metastases Advanced Non-Small Cell Lung Cancer By Chemotherapy.
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 主要终点
- Time of asymptomatic brain metastasis turn into symptomatic brain metastasis
研究概览
简要总结
This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and toxicity of erlotinib in patients with asymptomatic brain metastasis advanced NSCLC who was benefitted by first line chemotherapy. Patients with stage IV NSCLC who have one or more asymptomatic brain metastasis who was benefitted by first line chemotherapy will receive oral erlotinib 150mg once daily until disease progression or unacceptable toxicity. These patients' direct DNA sequencing of tumor tissue EGFR exons 18-21 will be analyzed The response was evaluated by RECIST criteria after the patient received erlotinib 6 weeks.If the patients present with progress disease of brain metastasis after the therapy of erlotinib, the patients will receive irradiation of brain metastasis.If the response is stable disease,partial response or complete response,he will be examined by brain MRI every 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
non-randomized open-label uncontrolled phase II trial erlotinib 150mg qd until disease progression or unacceptable toxicity
干预措施: erlotinib (Drug)
结局指标
主要结局
Time of asymptomatic brain metastasis turn into symptomatic brain metastasis
时间窗: 3/2008~3/2011
次要结局
- To determine objective response (CR+PR), time to progression, 6-month survival and 1-year survival,safety.(3/2008~3/2011)
