Radiotherapy Versus Radiotherapy Combined With Temozolomide in High-risk Low-grade Gliomas After Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in patients with high-risk low-grade gliomas.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed supratentorial WHO grade II gliomas;
- •Aged 18 to 39 years without total resection, or aged 40 to 70 years with any extent of resection or biopsy;
- •Karnofsky performance score (KPS) ≥ 60;
- •No more than moderate neurologic symptoms and signs;
- •The interval between surgery and randomization is less than 12 weeks;
- •Have signed the consent form. -
排除标准
- •WHO grade I gliomas or high-grade gliomas according to WHO's grading system;
- •Have received prior radiation therapy to the head and neck region;
- •Have received prior chemotherapy;
- •Synchronous multiple primary malignant tumor excluding carcinoma of the cervix in situ or nonmelanomatous skin cancer;
- •Prior malignancy's disease-free survival less than 5 years;
- •Have active infection;
- •Patients are pregnant or breast-feeding. -
研究组 & 干预措施
RT+TMZ
干预措施: Temozolomide (Drug)
RT+TMZ
干预措施: intensity modulated radiation therapy (Radiation)
RT
干预措施: intensity modulated radiation therapy (Radiation)
结局指标
主要结局
Progression-free survival
时间窗: up to 120 months
Our primary outcome is progression-free survival which is calculated from the date of randomization to the date of first reported disease progression or the date of death.
次要结局
未报告次要终点
研究者
Xingchen Peng
PhD, Associate Professor
West China Hospital