EUCTR2010-022189-28-SE进行中（未招募）1 期
A PHASE II OPEN-LABEL, RANDOMIZED, MULTI- CENTRE COMPARATIVE STUDY OF BEVACIZUMAB-BASED THERAPY IN PAEDIATRIC PATIENTS WITH NEWLY DIAGNOSED SUPRATENTORIAL, INFRATENTORIAL CEREBELLAR, OR PEDUNCULAR HIGH-GRADE GLIOMA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 124
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
- •- Written informed consent obtained from the patient/parents or legally acceptable representative
- •- Paediatric patients, age >/=3 years and <18 years
- •- Newly diagnosed localized, supratentorial- or infratentorial cerebellar or peduncular, WHO Grade III or IV gliomas
- •- Local histological diagnosis confirmed by a designated central reference neuropathologist
- •- Availability of a baseline MRI performed according to imaging guidelines
- •- Able to commence trial treatment not before 4 weeks after cranial surgery and no later than 6 weeks following the last major surgery
- •- Adequate bone marrow, coagulation, liver, renal function
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 130
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Metastatic (HGG) defined as evidence of neuraxis dessimination by MRI or positive CSF cytology
- •- WHO-defined Gliomatosis cerebri (multifocal HGG)
- •- Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications
- •- Radiological evidence of surgically related intracranial bleeding
- •- Prior diagnosis of a malignancy and disease-free for 5 years
- •- Prior systemic anti-cancer therapy
- •- Previous cranial irradiation
研究者
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