NCT03675230Unknown不适用
Study of Tomotherapy HD in Medulloblastoma
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2018年1月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- QoL(quality of life)
研究概览
简要总结
The aim of the study was to improve local control and long-term survival in children with medulloblastoma, reduce the side effects of treatment and improve quality of life.
详细描述
The technical advantages of Tomotherapy HD in the radiotherapy of children medulloblastoma (advantages in clinical operation and physics) were transformed into clinical advantages, and the possible mechanisms were explored.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient was diagnosed as myeloblastoma by surgical pathology with definite pathological classification. MRI of the head and spinal cord before and after operation, with definite staging; Radiotherapy was performed within 28 days after surgery.
排除标准
- •Previous radiotherapy in the whole brain, whole spinal cord or primary focus; Postoperative radiotherapy for more than 28 days.
研究组 & 干预措施
3DCRT
Active Comparator
This arm will be planned by 3DCRT to the treatment of the Medulloblastoma
干预措施: 3DCRT (Device)
Tomotherapy HD，TOMO
Experimental
This arm will be planned by TOMO to the treatment of the Medulloblastoma
干预措施: Tomotherapy HD (Device)
结局指标
主要结局
QoL(quality of life)
时间窗: 2 years
Changes in quality of life were assessed by EORTC QLQ-C30
次要结局
- PFS (progression free survival)(2 years)
- OS (overall survival)(2 years)
研究者
研究点 (1)
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