NCT03366376Unknown2 期
A Phase II Multi-institutional Study of Hippocampus-sparing Whole Brain Radiotherapy and Simultaneous Integrated Boost for Multiple Brain Metastases From Non-small Cell Lung Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Intracranial progression free survival
研究概览
简要总结
This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. The primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival, adverse events according to CTCAE v4.03, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven diagnosis of primary non-small cell lung cancer
- •3 or more measurable brain metastasis ≥3 mm outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI within 14 days prior to registration
- •Age ≥55 years
- •Informed consent prior to study entry
排除标准
- •Patients with leptomeningeal metastases
- •≥3 organ sites of extracranial metastases (including lung-to-lung metastases) within 3 months
- •Contraindication to MRI such as implanted metal devices or foreign bodies
- •Prior radiation therapy (including SRS) to the brain
结局指标
主要结局
Intracranial progression free survival
时间窗: until 12 months
Time from the date of start of radiotherapy to the date of death or intracranial progression
次要结局
- Quality of life(3,6,12 months)
- Adverse events(3,6,12 months)
- Verbal neurocognitive function (Seoul Verbal Learning Test-Elderly, SVLT-E)(3,6,12 months)
- Overall survival(until 12 months)
研究者
研究点 (2)
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