Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 30
- 主要终点
- Efficacy of SBRT assessed 6 months after treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.
详细描述
SBRT (Stereotactic Body Radiation Therapy) is a radiotherapy treatment which involves the delivery of a single high dose radiation treatment or a few fractionated radiation treatments (usually up to 5). A high potent biological dose of radiation is delivered to the tumor improving the cure rates for the tumor, in a manner previously not achievable by standard conventional radiation therapy.
For adult patients, the "Haute Authorité de Santé" (HAS) validates some indications for this treatment which are the followings :
- Few primary or secondary brain tumors, which cannot be surgically removed
- Spinal tumors
- Primary bronchopulmonary tumors T1 T2 N0 M0 and pulmonary metastasis with slow growth and controled primary tumor.
For pediatrics patients, no indication is now validated by HAS. Indications validated for adults are rare in pediatrics but not exceptional, and in such cases efficient alternative treatments does not exist.
In consequence, and regarding the good results obtained in adult patients, it seems very important to validate the efficacy of this treatment on pediatrics population
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
- 18 Months 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Efficacy of SBRT assessed 6 months after treatment
时间窗: 6 months after inclusion
The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)
次要结局
- Efficacy of SBRT assessed 12 months after treatment(12 months after inclusion)
- Efficacy of SBRT assessed between 1,5 and 3 months after treatment(Between 1,5 and 3 months after inclusion)
- Overall Survival(From the date of inclusion to the date of death (Up to 5 years since the first inclusion))
- Short time Safety profile of SBRT(From inclusion to 3 months after inclusion)
- Efficacy of SBRT assessed 24 months after treatment(24 months after inclusion)
- Progressive Free Survival(From the date of inclusion to the date of progression)
- Medium time Safety profile of SBRT(Between 3 months and 24 months after inclusion)
- Long term Safety profile of SBRT(after 24 months after inclusion)