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临床试验/NCT00663689
NCT00663689Unknown2 期

A Phase II Study of Erlotinib in Benefitted Patients With Asymptomatic Brain Metastases Advanced Non-Small Cell Lung Cancer By Chemotherapy.

Guangdong Provincial People's Hospital0 个研究点目标入组 45 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

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)

研究者

申办方类型
Other

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