Phase II Study of Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Progression free of participants
研究概览
简要总结
The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.
详细描述
Investigators designed this study of a re-irradiation with single radiosurgery or hypofractionated intensity modulated radiation therapy (IMRT) with or without temozolomide.
Objective of the study is evaluating efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other 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 —（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
- •Patients aged >70 years with KPS ≥80
- •Histopathologically confirmed grade III-IV glioma
- •Estimated survival ≥ 3 months
- •Any Tumor volume
- •Unifocal tumor
- •Interval time from previous radiotherapy ≥ 6mesi
- •Normal liver, Kidney and bone marrow function
- •Written informed consent
排除标准
- •KPS < 70
- •Multifocal tumor
- •Other primary cancer
- •Pregnant women
研究组 & 干预措施
Recurrent high grade glioma
IMRT with or without radiosensitive therapy
干预措施: IMRT with or without radiosensitive therapy (Radiation)
Recurrent high grade glioma
IMRT with or without radiosensitive therapy
干预措施: Radiosensitive therapy (Drug)
结局指标
主要结局
Progression free of participants
时间窗: 4 years
Overall survival of participants
时间窗: 4 years
次要结局
- Incidence of radionecrosis(3 months)
- Questionnaire assessment of neurocognitive function(6 months)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas