EUCTR2006-001545-34-IT进行中（未招募）不适用
Evaluating primary chemotherapy with temozolomide continuative low dose in patients with low grade gliomas grade II WHO - Continuative temozolomide in low grade gliomas
ISTITUTI FISIOTERAPICI OSPITALIERI0 个研究点目标入组 45 人开始时间: 2006年4月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically proven low grade diffuse glioma Astrocytoma WHO grade II gemistocytic, fibrillary and protoplasmatic , Oligoastrocytoma WHO grade II and oligodendroglioma WHO II; Newly diagnosed; Requiring treatment as demonstrated by at least one of the following criteria 1. measurable disease after surgery or biopsy 2. Prior radiotherapy, if any, have to be completed at least 8 weeks before enrollment 3. Neurological symptoms others than seizures only focal deficits, signs of increased intracranial pressure, mental deficits ; 4. Intractable/drug-resistent seizures; 5. Age 40 years; Karnofsky PS 60; Adequate hematological, renal and hepatic function; No prior chemotherapy; Written informed consent 1p/19q FISH analysis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Recurrent/progressive low grade astrocytoma with histological or radiological signs of anaplastic progression.
研究者
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