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临床试验/NCT01067196
NCT01067196已完成不适用

A Study of Late Effects After Proton Radiotherapy for Pediatric Tumors of the Brain, Head, and Neck

University of Florida1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年2月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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