EUCTR2007-000128-42-DE进行中（未招募）1 期
International cooperative Phase II trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children = 3 years and adolescents < 18 years. - HIT-HGG-2007
Martin-Luther-University Halle-Wittenberg0 个研究点目标入组 456 人开始时间: 2008年6月2日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 456
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
入选标准
- •Newly diagnosed, previously untreated high grade glioma with central neuropathological review including glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic mixed glioma/anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (WHO III), giant cell glioblastoma (WHO IV), and gliosarcoma (WHO IV)
- •Newly diagnosed, previously untreated diffuse intrinsic pontine glioma of all tumour grades or without histology when confirmed by central neuroradiological review
- •Newly diagnosed, previously untreated gliomatosis cerebri of all tumour grades with central neuropathological review and neuroradiological review
- •Patient aged 3 years and older but under 18 years at time of diagnosis
- •Written informed consent of the patient and/or the patient’s parents or legal guardian according to national laws
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 456
- •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
- •Pre-treatment differing from study protocol
- •Known hypersensitivity or contraindication to study drugs and/or dacarbazine
- •Prior chemotherapy or radiotherapy which prevents adequate performance of radiotherapy as outlined by the present protocol. This may mainly apply to patients with secondary malignant glioma after a previous malignant brain tumour, e.g. medulloblastoma, supratentorial PNET. If previous treatment does not prevent the adequate performance of the outlined treatment protocol patients with secondary malignant glioma will be eligible for the present trial.
- •Other (simultaneous) malignancies
- •Pregnancy and / or lactation
- •Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile)
- •Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
- •Very poor clinical condition as defined by demand of mechanical ventilation and/or demand for intravenous catecholamines and/or very severe neurological damage equivalent to a coma and/or tetraplegia with complete incapability for communication (deafness, blindness, mutism)
- •Severe concomitant diseases (e.g. immune deficiency syndrome)
- •Known HIV positivity
- •Country-specifically very young patients may be excluded to comply with national laws or formal insurance requirements
研究者
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