NCT00147160已完成2 期
Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 4
- 主要终点
- Radiological response after two courses of Temozolomide-Cisplatinum
研究概览
简要总结
The purpose of this study is to determine whether the combination of Temozolomide and Cisplatinum is effective in the treatment of malignant glial tumours of children and adolescents
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 4th birthday and younger than 21st birthday
- •Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours
- •Measurable and evaluable disease by the imaging criteria (MRI)
- •Patient not previously treated by either of the two drugs
排除标准
- •Malignant brain stem tumours are excluded
结局指标
主要结局
Radiological response after two courses of Temozolomide-Cisplatinum
次要结局
- Progression-free survival
- Health status and quality of life
- Toxicity
研究者
研究点 (4)
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