A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Over-all survival
研究概览
简要总结
This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.
详细描述
This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years to 75 years
- •newly diagnosed WHO III-IV glioma after operation and radiotherapy
- •Karnofsky Performance Score ≥ 60
- •Adequate bone marrow, liver and renal function
- •Ability of subject to understand character and individual consequences of the clinical trial
- •Written informed consent
- •anticipating survival ≥2 months
排除标准
- •Refusal to participate the study
- •Known hypersensitivity or contraindication to temozolomide
- •Incompletely radiation
- •Pregnant or lactating females
- •Malignant tumor other than brain tumor
- •Contraindicated for MRI examination
- •Unable to comply with the follow-up studies of this trial
- •Purulent and chronic infected wounds
- •Uncontrolled psychotic disorders or epilepsy
研究组 & 干预措施
temozolomide
Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide (150 mg/m^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles)
干预措施: Temozolomide (Drug)
temozolomide +α-IFN
Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN：3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles
干预措施: Temozolomide (Drug)
temozolomide +α-IFN
Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN：3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles
干预措施: α-IFN (Drug)
结局指标
主要结局
Over-all survival
时间窗: 5-year
次要结局
- Quality of life(5-year)
研究者
Zhongping Chen
Professor and Chair, Department of Neurosurgery
Sun Yat-sen University