A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation
概览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- progression free survival
概览
简要总结
This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation.
详细描述
This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation. And, this trial is approved by medical ethics committee of hebei yanda hospital. Also, the trial has got a registry code "ChiCTR-OOC-15005759" in China clinical trial registry. Researchers will conduct thsi trial from 2015/02 to 2017/12, and 100 recurrent high-grade glioma with IDH1/2 mutation patients will be recruited. Patients who are recruited will get PCV chemotherapy 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
- •A diagnosis of high-grade glioma was established by pathological method,and the recurrency of the disease is ongoing.
- •The report of the pathological diagnosis contained the status of IDH gene, and showed that IDH1/2 mutation existed.
- •The age of the patient is between 18 years old and 70 years old.
- •The condition of the patient permits the procedure of chemotherapy using PCV schema.
- •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.
- •No molecular neuropathological report is available, or the report showed that IDH1/2 mutation did not exist.
- •The age of the patient does not meet the requirement of this research.
- •The condition of the patient does not permit the procedure of chemotherapy using PCV schema.
- •There are other conditions that the clinicians believe that the PCV chemotherapy is not appropriate for the patient.
- •The patient is not willing to join in this research.
研究组 & 干预措施
case group
干预措施: Lomustine/Vincristine/Procarbazine (Drug)
结局指标
主要结局
progression free survival
时间窗: 12 months or later
次要结局
- 6-month progression-free survival rate(6 month)
- 12-month progression-free survival rate(12 month)
- 6-month survival rate(6 month)
- 12-month survival rate(12 month)
- 6-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30,EORTC QLQ-BN20) and other methods(6 month)
- 12-month life quality as measured by European Organization for the Research and Treatment of Cancer Quality of Life questionnaires(EORTC QLQ-C30,EORTC QLQ-BN20) and other methods(12 month)