EUCTR2005-005377-29-IE进行中（未招募）1 期
International Consortium on Low Grade Glioma - ICLGG of the International Society of Pediatric Oncology - SIOPCooperative multicenter Study for Children and Adolescents with Low Grade Glioma SIOP - LGG 2003 - LGG2
Our Lady's Hospital for Sick Children0 个研究点开始时间: 2006年5月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Age: children and adolescents up to age 16 years.
- •2. Histology: Glioma of low grade malignancy ( ICD O-Code )
- •Pilocytic Astrocytoma I°9241/3
- •Subependymal Giant Cell Astrocytoma I°9384/1
- •Dysembryoplastic Neuroepithelial Tumor I°9413/0
- •Desmoplastic Infantile Ganglioglioma I°9505/0
- •Ganglioglioma I° and II°9505/1
- •Pleomorphic Xanthoastrocytoma II°9424/3
- •Oligodendroglioma II°9450/3
- •Oligoastrocytoma II°9382/3
- •Astrocytoma II°9400/3
- •Fibrillary Astrocytoma II°9420/3
- •Protoplasmatic Astrocytoma II°9410/3
- •Gemistocytic Astrocytoma II°9411/3
- •Within the randomized part of the study all histologies will be randomized, since up to now there are no data to exclude any of the subgroups, e.g. children with oligodendroglioma, from this study.
- •Specific neuroradiological criteria may allow to diagnose a low grade chiasmatic-hypothalamic tumor without biopsy
- •3. Primary tumor localization: intracranial and spinal cord.
- •4. Dissemination: Children presenting with disseminated low grade glioma will be eligible for the study.
- •5. Associated conditions: Children are eligible for the trial regardless of the presence of associated genetic disease
- •6. Primary tumor diagnosis: The tumor should not be pretreated with chemotherapy or radiotherapy.
- •7. Informed consent: The patient and/or his legal guardian ( parents ) have to have declared their written informed consent to the study.
- •Randomization: All eligible patients without Neurofibromatosis NF I receiving chemotherapy as their first non-surgical therapy are eligible for randomization.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1. Primary tumor localization: diffuse intrinsic tumors of the pons, even if histologically an Astrocytoma II° is diagnosed.
- •Exception: pontine glioma II° in NF I patients may be entered into the study.
- •2. Special diagnosis: Patients presenting with rare intracranial neoplasms of low grade malignancy, but non-glial origin. Their data may be registered however, to learn about those therapeutic interventions which may prove useful to these patients and to develop separate strategies in the future. Choroid plexus papilloma should be entered on the SIOP-CPT-study.
- •3. Pretreatment: Children treated with chemo- or radiotherapy prior to entering the study will be evaluated separately. Previous treatment with steroids is not considered a chemotherapeutic treatment.
- •4. Preexisting impairments of health status, making the conduct of the study impossible or ethically unwise.
- •5. Evidence of pregnancy or lactation period.
- •In case the patient participates in another clinical study simultaneously to being enrolled in the study SIOP-LGG 2003, but not interfering with the present treatment strategy ( e.g. endocrinologic study ), this should be known to the national study chairmen.
- •Concommittant medication for associated or other conditions ( e.g. hormone replacement, anticonvulsants ) should be recorded, but is no exclusion criteria.
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