Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
研究概览
简要总结
This study is to evaluate the effectiveness of ultra-low dose Bevacizumab plus Temozolomide for recurrent high-grade gliomas.
详细描述
This trial is aimed at evaluating the effectiveness of ultra-low dose Bevacizumab plus Temozolomide for recurrent high-grade gliomas. And, this trial is approved by medical ethics committee of Hebei Yanda Hospital.Researchers will conduct thsi trial from 2015/05 to 2018/05, and 30 recurrent high-grade glioma patients will be recruited. Patients who are recruited will get treatment of ultra-low dose Bevacizumab plus Temozolomide in ether Hebei Yanda Hospital or Beijing Tiantan hospital, and get follow-ups from clinicians.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High grade glioma was diagnosed by post-operation pathological method, and shows a relapse.
- •Before included, the patient needs imageological examinations, and the diameter of contrast enhancing area is bigger than 1cm, PET or MRS results show positive features.
- •The age of patient should be between 18 years old and 70 years old.
- •The condition of the patient permits the treatment of ultra-low dose Bevacizumab plus Temozolomide.
- •The patient is informed consent,and willing to join in this research.
排除标准
- •The diagnosis is not recurrent high-grade glioma.
- •The diagnosis of high-grade glioma was not established by pathological method.
- •The results of imageological examinations do not meet the standard of including.
- •The age of the patient does not meet the requirement of this research.
- •The condition of the patient does not permit the treatment of ultra-low dose Bevacizumab plus Temozolomide.
- •There are other conditions that the clinicians believe that the treatment of ultra-low dose Bevacizumab plus Temozolomide is not appropriate for the patient.
- •The patient is not willing to join in this research.
研究组 & 干预措施
patient group
干预措施: Ultra-low dose Bevacizumab (Drug)
patient group
干预措施: Temozolomide (Drug)
结局指标
主要结局
6-month survival rate of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment
时间窗: 6 months
12-month survival rate of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment
时间窗: 12 months
次要结局
- Progression free survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment(6 months or later, up to 12 months)
- 6-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30 and EORTC QLQ-BN20 together)(6 months)
- Overall survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment(12 months or later, up to 24 months)
- Progression free survival of recurrent WHO-III glioma patients under ultra-low dose Bevacizumab plus Temozolomide treatment(12 months or later, up to 24 months)
- 12-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30 and EORTC QLQ-BN20 together)(12 months)
- Overall survival of recurrent glioblastoma multiforme patients under ultra-low dose Bevacizumab plus Temozolomide treatment(6 months or later, up to 12 months)