Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Duration of survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. 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. It is not yet known whether standard radiation therapy, higher-dose radiation therapy, or chemotherapy is more effective in treating older patients with glioblastoma multiforme.
PURPOSE: This randomized phase III trial is studying standard radiation therapy to see how well it works compared with higher-dose radiation therapy or chemotherapy in treating older patients with glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Compare the survival of patients over 60 with glioblastoma multiforme treated with standard radiotherapy vs hypofractionated radiotherapy vs chemotherapy.
Secondary
- Compare the quality of life (QLQ-C30) of these patients.
- Compare the safety, tolerance, and toxicity of these regimens.
- Assess the pharmacoeconomic cost of these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 60 Years 至 —（Adult, 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
Arm I
Patients undergo standard radiotherapy 5 days a week for 6 weeks.
干预措施: radiation therapy (Radiation)
Arm II
Patients undergo hypofractionated radiotherapy 5 days a week for 2 weeks.
干预措施: hypofractionated radiation therapy (Radiation)
Arm III
Patients receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: temozolomide (Drug)
结局指标
主要结局
Duration of survival
次要结局
未报告次要终点