NCT00385398撤回2 期
Phase II Quality of Life Study of Stereotactic RadioSurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Cognitive function
研究概览
简要总结
RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function (the ability to think, learn, remember, and judge) in patients with non-small cell lung cancer and brain metastases. A study that evaluates brain function may help doctors plan the best treatment.
PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and erlotinib on brain function in patients with non-small cell lung cancer and brain metastases.
详细描述
OBJECTIVES:
Primary
- Determine the effect of stereotactic radiosurgery, temozolomide, and erlotinib hydrochloride on cognitive function in patients with non-small cell lung cancer and brain metastases.
Secondary
- Determine the feasibility and safety of this regimen, in terms of tumor response, time to tumor progression in brain, survival, physical functioning, and quality of life, in these patients.
- Determine the frequency of O6-methylguanine-DNA methyltransferase promoter methylation in these patients.
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
结局指标
主要结局
Cognitive function
时间窗: 2 years
次要结局
- Tumor response(2 years)
- Time to tumor progression in brain(2 years)
- Survival(2 years)
- Quality of life as measured by FACT subscale(2 years)
- Physical functioning as measured by Karnofsky performance status and Katz index of activities of daily living(2 years)
- Frequency of O6-methylguanine-DNA methyltransferase promoter methylation(2 years)
研究者
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