NCT01670890Unknown2 期
Efficacy and Safety of Salvage Treatment With Dose-dense TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas: a Multicentre,Prospective Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- over all survival
研究概览
简要总结
Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ. Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment procedure has not been established yet.
The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of TMZ and CDDP in patients with recurrent malignant gliomas
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Written informed consent
- •Age>=18 and <=70years old
- •Histological diagnosis of malignant gliomas(WHO III or IV)
- •The status of methylation of promotor of MGMT should be detected.
- •The time to be enrolled should be more than 90 days after the irradiation.
- •The patients with recurrent gliomas were treated with non-dose-dense TMZ therapy before enrollment.
- •Performance status(Karnofsky index)>=60
- •Life expectancy more than 3 months
排除标准
- •Ages:< 18 years or > 70 years
- •Abnormal function of liver or renal(value more than 1.5 fold normal upper limit )
- •Blood routing: Hb < 100g/l， WBC < 4.0×109/l; PLT < 100×109/l
- •Pregnant or lactating women
- •Allergic to administered drugs
- •Radiation treatment in the previous 90 days or stereotactic radiation surgery within 60 days before enrollment
- •The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment.
- •Life expectancy less than 3 months
- •Participation in other clinical trials in the 90previous days before enrollment
研究组 & 干预措施
TMZ group
Active Comparator
patients were treated with TMZ alone
干预措施: TMZ (Drug)
TMZ plus CDDP group
Experimental
patients were treated with TMZ plus CDDP
干预措施: TMZ plus CDDP (Drug)
结局指标
主要结局
over all survival
时间窗: 1 year
次要结局
- progression free survival(6 months)
研究者
研究点 (3)
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