Tumor Bed Hypofractionated IMRT (VMAT-RA) After Surgical Resection for Patients With Single, Large (≥2.1 cm) Brain Metastases From Solid Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Local control rate
研究概览
简要总结
Investigators designed a study of a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for patients with single, large brain metastases from solid primary tumor
详细描述
Investigators designed a study to recruit patients with single, large brain metastases from solid primary tumor for a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach. The potential advantage of this treatment is to improve local control and to reduce toxicity compared with WBRT or SRS after surgical resection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Karnosky performance status (KPS) ≥70
- •All Solid tumor (esclusion SCLC and Germinal tumors)
- •Controlled primary tumor
- •Controlled other metastatic site
- •Single metastatic lesion at diagnosis
- •Lesions ≥ 2.1 cm in maximum diameter (4 cm3), < 3 cm conditioning mass effect or neurological deficits or massive aedema, unknown primary tumor
- •Estimated survival ≥ 3 months.
- •Written informed consent
排除标准
- •Prior WBRT
- •Other primary cancer
- •Pregnant women
研究组 & 干预措施
brain metastatic patients
Patients with single, large brain metastases from solid tumors
干预措施: brain metastatic patients (Radiation)
结局指标
主要结局
Local control rate
时间窗: 6 months
次要结局
- Distant brain failure(6 months)
- Overall survival, statistical(6 months)
- Morbidity/mortality after surgery(1 month)
- Radionecrosis after treatments(6 months)
- Neuropsycological alterations after treatments, questionnaire(6 months)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas