Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of patient survival associated with relapse rate after surgery
研究概览
简要总结
High grade glioma is a rare disorder affecting children at all ages with a high mortality rate. Overall survival is estimated at 40%, depending on the type of treatment administered. Major late sequelaes are experienced with the irradiation in this population under 5 years. Therefore, the current recommendations by The French Society for Childhood Cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. The results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. Few studies concerning evaluation of treatment toxicity and long term outcomes are available. Therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. This retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under 5 years old
- •High grade glioma (WHO status III or IV)
- •No previous treatment with chemotherapy or radiotherapy
- •No contraindication to chemotherapy
- •Consent of legal representative for participation in the study
排除标准
- •Low grade glioma
- •Any other histological pattern
- •Parent's denial to access data concerning their child in the frame of medical research
结局指标
主要结局
Assessment of patient survival associated with relapse rate after surgery
时间窗: 10 years
Assessment of patient survival associated with relapse rate after chemotherapy
时间窗: 10 years
次要结局
未报告次要终点
