NCT00076856已完成2 期
A Randomized, Open-Label Phase 2 Study of Temozolomide Added to Whole Brain Radiation Therapy Versus Whole Brain Radiation Therapy Alone for the Treatment of Brain Metastasis From Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.
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
- •Age greater than or equal to 18
- •Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
- •At least one brain metastasis diagnosed within 30 days of randomization
- •Brain metastases must not have been previously treated with WBRT or radiosurgery
- •No more than 2 sites of extracranial metastases
- •May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites
- •Meets protocol requirements for specified laboratory values.
- •Written informed consent and cooperation of patient
- •Appropriate use of effective contraception if of childbearing potential.
- •Karnofsky Performance Status KPS greater than 70
- •Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)
排除标准
- 未提供
结局指标
主要结局
Overall Survival
次要结局
- Time to radiological CNS progression
研究者
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