NCT03002532Unknown不适用
Whole Brain Irradiation With Hippocampal Sparing for Brain Metastases From Breast Cancer: Neurocognitive Function and Prognosis Analysis
Affiliated Hospital to Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- neurocognitive function
研究概览
简要总结
Based on evidence that radiation-induced damage to the hippocampus plays a considerable role in neurocognitive decline after cranial irradiation, hippocampal-sparing whole brain radiation therapy (HS-WBRT) has been proposed. This study will investigate the neurocognitive function and prognosis between HS-WBRT and conventional WBRT for the treatment of brain metastases from breast cancer.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with advanced breast cancer who is confirmed historically.
- •New developing brain metastases (BM) is confirmed by gadolinium contrast-enhanced magnetic resonance imaging (MRI), with or without clinical symptoms and pathology, and without a history of BM treatment.
- •At least 2 BM lesions with the diameter of the largest lesion < 40 mm is eligible. And the distance from the border of a mass to the hippocampal margin should be more than 15 mm.
- •The Eastern Cooperative Oncology Group (ECOG) is from 0 to 2, and the expected life expectancy is ≥3 months.
排除标准
- •Concurrent chemoradiation.
- •Patient who had received cranial irradiation previously.
- •Patient who are enrolled in other clinical trial at the same time.
- •Patient who has severe co-morbidity or infection.
结局指标
主要结局
neurocognitive function
时间窗: 1 years
delayed recall using Hopkins Verbal Learning Test
次要结局
- time to intracranial progression(2 years)
- patient-reported quality of life(2 years)
- overall survival after brain metastases(2.5 years)
- quality of life(2 years)
研究者
研究点 (1)
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