Craniospinal Irradiation in Histone AlteRed Midline Glioma (CHARM) - A Phase II Open Label Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Survival Outcomes
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 the investigator 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.
详细描述
Introduction: Paediatric H3K27/H3G34 mutant diffuse midline gliomas (DMGs) are aggressive high-grade gliomas predominantly affecting midline structures and cerebral hemispheres. Despite aggressive therapy including radiation and chemotherapy, these tumors carry a poor prognosis, particularly in children, with frequent recurrence and high risk of leptomeningeal spread. Current standard treatment involves definitive radiation therapy to the primary site and concurrent temozolomide chemotherapy following histological confirmation via biopsy. However, outcomes remain suboptimal, prompting exploration of more intensive therapeutic strategies.
Primary objective:
To study if the addition of craniospinal irradiation to standard practice improves outcomes in pediatric diffuse midline glioma.
Secondary objectives:
- Estimate median time to leptomeningeal dissemination and compare with historical control
- Study patterns of failure
- Early and late toxicities
- Study quality of life indices
- To estimate QTWiST (Quality of life without symptoms or toxicity)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed biopsy proven histone altered diffuse midline glioma
- •Age- ≥3 to <18 years at time of diagnosis
- •Karnofsky/Lansky Performance Score more than or equal to 70
- •Has provided written informed consent/ assent form
- •No prior therapy except debulking surgery or biopsy
排除标准
- •Recurrent or progressive disease
- •Clinical features or family history suggestive of Inherited Cancer Predisposition such as Constitutional Mismatch Repair Deficiency (CMMRD)
- •Previous history of malignancy
- •Not willing /unlikely to comply with proposed therapy and follow up
结局指标
主要结局
Survival Outcomes
时间窗: at 12 months
Overall survival- time in months between the date of diagnosis to date of death due to any cause
次要结局
- Leptomeningeal Dissemination(at 12 months)
- Patterns of failure(at 12 months)
- Any treatment emergent acute toxicity recording(Baseline , week 1 , week 2 , week 3 , week 4 , week 5 ,week 6 , conclusion of RT)
- Quality of life indices(will be done at 3 months)
- QTWiST (Quality of life Without Symptoms or Toxicity) calculation(will be done at 3 months)
- Any treatment emergent late toxicity recording(After completion of 6 cycles of adjuvant chemotherapy, at 3months, 6months, 9months and 12months follow up)