NCT03841435已完成不适用
Feasibility Study of Hypofractionated Radiotherapy in the Setting of Recurrent Diffuse Intrinsic Pontine Glioma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Post Radiation Toxicity
研究概览
简要总结
This study evaluates the feasibility of hypofractionated radiotherapy (RT) in the palliative treatment of recurrent diffuse intrinsic pontine glioma (DIPG). Participants will receive 15 Gy in 3 fractions as opposed to the standard 20 Gy in 10 fractions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≤30 years of age
- •Patients must have a diagnosis of progressive DIPG.
- •Received prior IMRT based definitive radiotherapy to a dose of ≥54 Gy.
- •The patient and or parent/legal guardian must be physically and mentally capable of signing the consent form of their own volition.
- •Steroids dosage must be unchanged for 5 days.
- •No Bevacizumab within 21 days (Half-life 11 days ~)
排除标准
- •Patients with incomplete medical records
- •Patients with prior history of reirradiation for DIPG
- •Life expectancy < or equal to 1 month
- •Pregnant women
- •Concurrent systemic therapy at the time of reirradiation
- •Physically or mentally incapable of signing the consent form of their own volition
- •< 6 mos time interval between completion of initial RT to start of reRT.
结局指标
主要结局
Post Radiation Toxicity
时间窗: Through Study Completion, an average of 1 year
RTOG common toxicity criteria grade 0-5
次要结局
- Progression Free Survival(Through Study Completion, an average of 1 year)
- Radiographic Response(1 month)
- Change in Quality of Life score(Pre-RT, 2 weeks, 1 month, 3 months and every 3 months there-after post RT)
- Overall Survival(Through Study Completion, an average of 1 year)
- Steroid Requirement(Through Study Completion, an average of 1 year)
研究者
Luke Pater
Associate Professor of Radiation Oncology, Mediacal Director, West Chester Hospital Radiotherapy
University of Cincinnati
研究点 (2)
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