CTIS2024-513654-30-00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). - DIPG
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 81
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 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) [Hargrave], Symptoms lasting less than 6 months, life expectancy =4 weeks; Karnowski/Lansky performance status = 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
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 dysfunction, 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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