A Randomized Phase III Study of Temozolomide and Short-Course Radiation Versus Short-Course Radiation Alone In The Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 562
- 试验地点
- 22
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether radiation therapy and temozolomide are more effective than radiation therapy alone in treating glioblastoma multiforme.
PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared with radiation therapy alone in treating patients with newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Compare overall survival rates in older patients with newly diagnosed glioblastoma multiforme treated with short-course radiotherapy with or without temozolomide.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Compare the nature, severity, and frequency of adverse events in patients treated with these regimens.
- Compare the quality of life of patient treated with these regimens.
- Determine the methylation status of the O6-methylguanine-DNA methyltransferase promoter.
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
- 65 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Temozolomide
Temozolomide and short course radiation
干预措施: temozolomide (Drug)
Temozolomide
Temozolomide and short course radiation
干预措施: DNA methylation analysis (Genetic)
Temozolomide
Temozolomide and short course radiation
干预措施: quality-of-life assessment (Procedure)
Radiation
Short course radiation alone
干预措施: DNA methylation analysis (Genetic)
Radiation
Short course radiation alone
干预措施: quality-of-life assessment (Procedure)
Radiation
Short course radiation alone
干预措施: Radiation (Radiation)
结局指标
主要结局
Overall Survival
时间窗: 7 years
Time from date of randomization to the date of death of any causes, or censored at last known alive date.
次要结局
- Progression-free Survival(7 years)
- Adverse Events(7 years)
- Methylation Status of the O6-methylguanine-DNA Methyltransferase Promoter(7 years)