Prospective Randomized Trial of Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Median overall-free survival
研究概览
简要总结
Hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. This study is to evaluate the clinical end results of the hypofractionated radiotherapy in DIPG compared to the conventional treatment. The non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital, stay or engagement, for more than its half with the same results.
详细描述
In lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic pontine glioma (DIPG), the investigators examined a hypofractionated radiotherapy regimen up to a dose of 39Gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks.
This schedule offers a reduction in patient burden, especially preferable in children with a poor compliance and performance status. The non-inferiority of the hypofractionated regimen in its clinical end-results, with the reduction of the overall treatment time to less than its half will decrease the burden for the patient, his/her family and the treating department. This will be considered as added value without compromising the survival or increasing side effects.
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
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with a diffuse intrinsic brainstem glioma, ages 3-18years, were eligible for this protocol.
- •Patients were required to have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.
- •No performance criteria were required for entry onto the study.
- •The diagnosis of DIPG based on a high-quality, gadolinium- enhanced magnetic resonance imaging (MRI) scan containing at least T1, T2 MRIs with gadolinium contrast in three series, as well as diffusion imaging.
- •Symptoms & signs of less than 3 months duration
排除标准
- •Children were not eligible if they had received any prior therapy other than steroid
- •The diagnosis of exophytic brainstem glioma
结局指标
主要结局
Median overall-free survival
时间窗: 3 years
Progression-free survival
时间窗: 3 Years
次要结局
未报告次要终点