A Study on β-elemene as Maintain Treatment for Complete Remission Patients of Newly Diagnosed Malignant Gliomas Following Standard Treatment
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 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 β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma.
详细描述
This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma. β-elemene will be given 600mg/d,d1-14,q28 days for 6 cycles.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Page 3 of 4 [DRAFT] - Arms Assigned Interventions
- •Temodar Experimental: 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 Drug: Temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
- •Other Names:
- •Temodar Drug: α-IFN 3mIU (3million) D1，3，5
- •Other Names:
- •Minimum Age: 18 Years Maximum Age: 75 Years Gender: Both Accepts Healthy Volunteers?: No
- •Criteria: Inclusion Criteria:
- •Age: 18 years to 75 years
- •complete remission patients of newly diagnosed WHO III-IV glioma following standard treatment
- •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
- •progression disease
研究组 & 干预措施
β-elemene
β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles.
干预措施: β-elemene (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
Sun Yat-sen University