NCT01067196已完成不适用
A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Measure late effects of proton therapy on pediatric patients with CNS tumors
研究概览
简要总结
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.
详细描述
Data collection will be obtained from the patient's medical records including initial evaluation, radiotherapy completion records and follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 20 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated >5 cc of the brain tissue to receive >5 CGE radiation
- •Patient must be less than 21 years of age at time of consent.
- •Patients that require localized and craniospinal irradiation.
- •Patients and/or patient parent must complete baseline Quality of Life Questionnaire as applicable by patient age group.
排除标准
- •Prior radiation therapy.
- •Evidence of metastases outside the central nervous system.
结局指标
主要结局
Measure late effects of proton therapy on pediatric patients with CNS tumors
时间窗: 5.4 years after treatment completion
次要结局
- Survival endpoints of local control, progression-free survival, and overall and cause-specific survival.(12 years after treatment completion)
研究者
研究点 (1)
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