NCT01878266已完成不适用
Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma
Children's Cancer Hospital Egypt 573572 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2013年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Median overall-free survival
研究概览
简要总结
This Trial offers a reduction in patient burden, which is especially preferable in children with a poor compliance and poor performance status. This prospective randomized trial was extension to the previous controlled prospective study performed in Children's Cancer Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this work is to demonstrate noninferiority of the hypofractionated regimens relative to the conventional regimen in a controlled randomized clinical study.
详细描述
In this study will add a third arm in which we will increase in the total dose to 4500 cGy in 15 fractions in 3 weeks may lead to improvement in Over-all survival or Progression-Free Survival.
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
- 2 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
- •Aged 2-18years,
- •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.
排除标准
- •Children were not eligible if they had received any prior therapy other than steroids Treatment
结局指标
主要结局
Median overall-free survival
时间窗: 3 years
次要结局
- Progression-free survival(3 years)
研究者
研究点 (2)
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