Evaluation the Prognostic Significance of High Radiation Dose in Malignant Glioma Patients Treated With Chemoradiation
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Progression Free survival rate
研究概览
简要总结
Simultaneous integrated boost (SIB), a field-in-field escalation technique, has been introduced to deliver higher radiation dose to the certain part of target with the same fractionation scheme. The aim of this study was to investigate the value of chemoradiation (CCRT) using SIB in glioblastoma and the correlation with surgical extent.
详细描述
The SIB technique provides the higher radiobiological effect with the same fractionation scheme, i.e. 69 Gy over 6 weeks, which might increase the loco-regional control. Besides, the co-registration with magnetic resonance imaging (MRI) strengthens the precision of target delineation as well as higher possibility to spare adjacent normal brain tissue.
In this protocol, the newly diagnosed, primary glioblastoma patients received SIB 69 Gy/30 fractions to preoperative tumor bed and surgical cavity, while 60 Gy/30 fractions were covering preoperatively edematous area. To determine the status of surgical extent, postoperative CT scan and MRI was acquired within 72 hours and at 4th week after surgery. During the period of chemoradiation, acute neurotoxicity and hematological toxicity was assessed as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or above
- •newly diagnosed, tissue-proven glioblastoma
- •pre-radiotherapy Karnofsky performance score (KPS) ≧60.
排除标准
- •any previous history of chemotherapy or radiotherapy
- •receiver of any investigating agents
- •recurrent GBM
- •any second malignancies.
研究组 & 干预措施
Simultaneous integrated boost
In this protocol, the newly diagnosed, primary glioblastoma patients receive SIB 69 Gy/30 fractions to preoperative tumor bed and surgical cavity, while 60 Gy/30 fractions were covering preoperatively edematous area. PTV is 5 mm.
干预措施: Simultaneous integrated boost (Radiation)
结局指标
主要结局
Progression Free survival rate
时间窗: at the end of first year
Actual one-year progression-free survival rate
次要结局
- Surgical extent(CT within 72 hours and MRI at 4th week after surgery)