Hippocampal Avoidance Whole Brain Irradiation With Simultaneous Integrated Boost for the Treatment of Lung Cancer Brain Metastases：A Prospective Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
Patients with lung cancer and brain metastases undergo HA-WBRT-SIB using image-guided radiotherapy, receiving a total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV is boosted to 44 Gy-52 Gy in 18-20 fractions, five times a week. The optimal mean dose (Dmean) to the bilateral hippocampus should optimally be ≤ 8 Gy, with a mandatory maximum dose (Dmax) to the hippocampus not exceeding 10 Gy; the preferred Dmean to the hippocampus PRV should optimally be ≤ 9 Gy, while the mandatory Dmax to the hippocampus PRV should be ≤ 12 Gy. The HVLT-R immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically diagnosed primary lung cancer with brain metastasis confirmed via magnetic resonance imaging (MRI);
- •18-75 years old;
- •BM outside a 10 mm margin around either hippocampus;
- •at least one BM existed if prior resection of BM was done;
- •BM measuring less than 5.0 cm in maximal extent;
- •Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-2
排除标准
- •previous brain radiotherapy or brain metastasis resection;
- •history of malignancies other than lung cancer;
- •radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases
- •presence of other serious illnesses such as acute myocardial infarction, severe arrhythmia, or psychiatric disorders within the past 6 months.
研究组 & 干预措施
HA-WBRT-SIB
Patients with lung cancer and brain metastases undergo HA-WBRT-SIB using image-guided radiotherapy, receiving a total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV is boosted to 44 Gy-52 Gy in 18-20 fractions, five times a week. The optimal mean dose (Dmean) to the bilateral hippocampus should optimally be ≤ 8 Gy, with a mandatory maximum dose (Dmax) to the hippocampus not exceeding 10 Gy; the preferred Dmean to the hippocampus PRV should optimally be ≤ 9 Gy, while the mandatory Dmax to the hippocampus PRV should be ≤ 12 Gy. The HVLT-R immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment.
干预措施: HA-WBRT-SIB (Radiation)
结局指标
主要结局
OS
时间窗: 24 months
the time from the end of brain radiotherapy to death from any cause
次要结局
- PFS(24 months)
- HVLT-R learning score(at baseline and 1, 3, and 6 months after radiotherapy)
- iPFS(24 months)
研究者
ZONG MEI ZHOU
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences