Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With Newly Diagnosed Glioblastoma Multiforme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed and pathologically confirmed glioblastoma multiforme without an enhanced lesion beside the cerebrospinal fluid space on baseline magnetic resonance imaging
- •Karnofsky performance status more than 60
- •Normal liver, kidney, and bone marrow function.
排除标准
- •Previous allergies to granulocyte macrophage colony stimulating factor
- •Receiving radiotherapy
- •Receiving other investigational agents
- •Had uncontrolled intercurrent illnesses.
研究组 & 干预措施
IMRT
Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor
干预措施: Hypofractionated IMRT (Radiation)
IMRT
Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor
干预措施: Granulocyte-macrophage Colony-stimulating Factor (Biological)
IMRT
Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor
干预措施: Temozolomide (Drug)
结局指标
主要结局
PFS
时间窗: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
次要结局
未报告次要终点