EUCTR2015-002185-23-IT进行中（未招募）1 期
Phase 2 open label randomized study of radiotherapy, concomitant nimotuzumab and vinorelbine and re-irradiation at relapse versus radiotherapy and multiple elective radiotherapy courses with concomitant vinorelbine and nimotuzumab for newly diagnosed childhood and adolescence diffuse intrinsic pontine glioma (DIPG) - INT - DIPG 2015
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
- 79
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
- •- Patients from 2 to 21 years old will be eligible
- •- No previous treatment consented apart from steroids
- •- Strict eligibility criteria will radiologically-verified DIPG (an intrinsic, pontine-based infiltrative lesion hypointense on T1- and hyperintense on T2-weighted sequences, involving at least 2/3 of the pons)
- •- Symptoms lasting less than 6 months
- •- Life expectancy =4 weeks
- •- Karnowski/Lansky performance status > or = 40 %
- •- No organ dysfunction
- •- No pregnancy or breast-feeding
- •- Patients undergo baseline cranial MRI with gadolinium, to be repeated if treatment begins more than 2 weeks; spinal MRI due to the occurrence of metastatic cases at diagnosis will also be mandatory
- •- Written and signed informed consent from parents or legal guardians will be obtained before starting the treatment-
- •- For diffuse midline glioma observational arm, central reviewed pathology of the disease according to standard Italian procedure, i.e. referral to the Neuropathology at Sapienza University in Rome.
- •Are the trial subjects under 18? yes
- •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 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients below 2 years or over 21
- •- Pre-treatment with radio or chemotherapy
- •- Neurofibromatosis 1
- •- Non-typical imaging
- •- Symptoms duration over 6 months, Lansky/Karnowski scores below 40
- •- Metastatic disease as shown by MRI
- •- Organ disfunction, pregnancy or breast-feeding
- •- Absence of parents, patient or tutor consent
- •- Not central review diagnosis of diffuse midline glioma histone H3, K27 mutated
研究者
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