Craniospinal irradiation in Histone AlteRed Midline glioma (CHARM) – A Phase II Open label prospective study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Paediatric H3K27/H3G34 mutant diffuse midline gliomas are high grade gliomas that arise in midline structures/cerebral hemispheres and are known to have dismal outcomes. Standard treatment includes definitive radiation therapy to primary site along with concurrent temozolomide chemotherapy following histological confirmation with a biopsy. Studies have shown poorer outcomes in the paediatric age group compared to that of adults and an increased risk to fail/recur in the leptomeninges(covering of brain and spinal cord). The following study is planned in order to assess the benefit of craniospinal irradiation(delivering radiotherapy to brain, spinal cord and its covering membrane in this high risk population. Thereby we aim to improve survival in newly diagnosed histone mutant pediatric midline gliomas in the upfront setting. Patterns of disease failure, treatment related toxicities and quality of life will also be assessed as a part of this study. If proven beneficial, this study will influence how patients with this diagnosis will be treated in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Newly diagnosed biopsy proven histone altered diffuse midline glioma 2.Age-More than equal to 3 to less than 18 years at time of diagnosis 3.Karnofsky/Lansky Performance Score more than or equal to 70 4.Has provided written informed consent/ assent form 5.No prior therapy except debulking surgery or biopsy.
排除标准
- •1.Recurrent or progressive disease 2.Clinical features or family history suggestive of Inherited Cancer Predisposition such as Constitutional Mismatch Repair Deficiency (CMMRD) 3.Previous history of malignancy 4.Not willing /unlikely to comply with proposed therapy and follow up.
结局指标
主要结局
Overall survival
时间窗: at 12 months
次要结局
- Time to leptomeningeal dissemination in months(- Incidence of different failure patterns from clinico-radiological assessment)
研究者
Dr Abhishek Chatterjee
Department of Radiation Oncology Neuro-oncology Disease Management Group Room number 1002 Homi Bhabha Building Tata Memorial Centre Mumbai MAHARASHTRA India