NCT00575887已完成2 期
Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-grade Gliomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Progression-free Survival at 6-months
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age >18 years old
- •Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme)
- •Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging
- •Karnofsky Performance Status scale >/=50 (due to brain pathology)
- •Adequate hematological, renal and hepatic function
- •Patients willing to participate in the study and signing the informed consent
排除标准
- •Karnofsky Performance Status scale <50
- •Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study
- •Patients not suitable for follow-up
研究组 & 干预措施
1
Experimental
干预措施: Temozolomide (Drug)
结局指标
主要结局
Progression-free Survival at 6-months
时间窗: Until progression
次要结局
未报告次要终点
研究者
Ufuk ABACIOGLU
Assoc. Prof.
Marmara University
研究点 (1)
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