Treatment Strategy for Low-grade Gliomas
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.
研究概览
简要总结
Although the prognosis of patients with low-grade glioma (LGG) is generally good, recurrence seems unavoidable in some patients because of the infiltrative growth of the tumors. How to treat LGGs is still under controversy. The role of radiation therapy and chemotherapy in the treatment of LGG need to be further investigated. The purpose of this study is the following:
- to investigate the role of early radiation therapy in MRI-determined total resected LGGs;
- to compare the efficacy of early radiation therapy and that of initial chemotherapy in the LGGs without total resection.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed newly diagnosed low-grade gliomas
- •Karnofsky performance status of 60 or more
排除标准
- •Previous history of radiation therapy or chemotherapy for gliomas
- •Pregnant or breast feeding
- •Diagnosis of another malignancy may exclude subject from study
- •Evidence or history of bleeding diathesis
- •Evidence or history of hypersensitivity to temozolomide
研究组 & 干预措施
Total resection with early radiation
Total resected LGGs treated with early radiation
干预措施: Radiation therapy (Radiation)
Residual LGGs with radiation
Residual LGGs treated with early radiation
干预措施: Radiation therapy (Radiation)
Residual LGGs with chemo
Residual LGGS treated with temozolomide
干预措施: Temozolomide (Drug)
结局指标
主要结局
Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.
时间窗: 10 years
Efficacy of early radiation therapy vs. initial chemotherapy with temozolomide in LGGs without total resection: evaluated as 5-year progression-free survival.
时间窗: 10 years
次要结局
未报告次要终点