Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 709
- 试验地点
- 89
- 主要终点
- Progression-free 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. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.
详细描述
OBJECTIVES:
Primary
- Compare the progression-free survival of patients with low-grade gliomas treated with radiotherapy vs temozolomide.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Determine whether the incidence of late toxicity can be decreased in patients who are randomized to receive temozolomide.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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
radiotherapy
Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
干预措施: radiation therapy (Radiation)
Temozolomide
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles (experimental arm)
干预措施: temozolomide (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 5 years
次要结局
- Overall survival(5 years)
- Adverse events as measured by CTCAE v3.0(As indicated in the protocol)
- Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20(every 3 months until progression, and then every 6 months until death)
- Mini-Mental State Examination(every 3 months until progression, and then every 6 months until death)