Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (NSCLC)

Samsung Medical Center2 个研究点分布在 1 个国家目标入组 176 人开始时间: 2008年6月最近更新: 2011年2月23日

适应症

试验速览

阶段: 3 期
发起方: Samsung Medical Center
入组人数: 176
试验地点: 2
主要终点: overall survival

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non small cell lung cancer (NSCLC).

Therefore, the investigators do a randomized study comparing overall survival between two groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative chemotherapy for NSCLC.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically confirmed non-small cell lung cancer with synchronous brain metastases
•One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:
•Well circumscribed tumor(s) with brain edema Grade 0-1
•Maximum diameter ≤ 3.0 cm
•No prior surgical treatment or RT for brain metastases
•No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
•Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0)
•Age, 18 and over
•ECOG performance status 0-1
•Written informed consent

排除标准

•severe co-morbid illness and/or active infections
•pregnant or lactating women
•RTOG neurologic function status of 1~4
•Uncontrollable extracranial metastases

结局指标

主要结局

overall survival

时间窗: 1 year after the enrollment of the last patient

次要结局

Time to CNS progression(1 year after the enrollment of the last patient)

研究者

发起方

Samsung Medical Center

申办方类型

Other

研究点 (2)

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