Hypofractionated accelerated Radiotherapy versus Conventional Radiotherapy in Glioblastoma Multiforme: A prospective randomised controlled study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Loco regional control
研究概览
简要总结
This is a prospective, open label randomised controlled study comparing the safety and efficacy of Hypofractionated accelerated Radiotherapy at 52.5 Grey in 15 fractions with Conventional Radiotherapy at 60 Grey in 30 fractions, both administered with concurrent temozolomide @ 75 mg/m2 once daily throughout radiotherapy and six cycles of adjuvant temozolomide @ 150-200 mg/m2 starting 4 weeks after Radiotherapy, administered once daily for 5 days and each cycle delivered at an interval of 4 weeks in 52 patients of Glioblastoma Multiforme. The study is single institutional which aims to assess loco-regional control as primary outcome and overall survival, progression free survival and Quality of life as secondary oiutcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Histologically proven patients of Glioblastoma Multiforme
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Patients willing to give written consent for the study.
排除标准
- •Recurrent cases of Glioblastoma Multiforme, previously treated.
- •Patients with any contraindications to Radiotherapy.
结局指标
主要结局
Loco regional control
时间窗: 2 years
次要结局
- Overall Survival(Progression free survival)
研究者
Dipanjan Nandi
Department of Radiotherapy and Radiation Medicine, Institute of Medical Sciences, BHU, Varanasi
