Feasibility of Vertebral Body Sparing Intensity Modulated Proton Therapy Craniospinal Irradiation With in Vivo Range Verification in Growing Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Dose delivered to vertebral bodies and quality assurance of treatment plans
研究概览
简要总结
This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.
详细描述
PRIMARY OBJECTIVES:
I. To demonstrate the feasibility and safety of using intensity modulated proton therapy to deliver vertebral body sparing craniospinal irradiation in growing children.
Ia. To report the dose received to the vertebral bodies and the dose gradient/heterogeneity within the vertebral body.
Ib. To document, using weekly cone beam computed tomography (CT) of the cervical and lumbar spine, delivered dose in comparison with planned dose after accounting for any errors in patient positioning.
II. To evaluate acute toxicity of vertebral body sparing (VBS) craniospinal irradiation (CSI).
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
- •Pathologic diagnosis of central nervous system malignancy requiring craniospinal irradiation.
- •Signed informed consent and assent when indicated.
排除标准
- •Any contraindication to undergoing MRI (ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial cardiac valves or devices, electrical implants such as cardiac pacemakers or perfusion pumps). Metal fragments, shrapnel, or tattoos near the eye.
- •Any major uncontrolled or poorly controlled current illness that would limit compliance with study requirements.
- •Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
结局指标
主要结局
Dose delivered to vertebral bodies and quality assurance of treatment plans
时间窗: Up to 2 years
Multiple measurements will be aggregated to arrive at one reported value when toxicities are graded (1-5). Dose statistics are in units of Gy or may be %
Bone marrow changes on MRI
时间窗: At baseline, and fractions 7, 13, 20, and 30 of radiation therapy
Will be quantitatively and qualitatively analyzed in relationship to the proton dose distribution
Incidence and severity of acute hematologic toxicity
时间窗: Up to 2 years
Will be graded according to Common Terminology Criteria for Adverse Events version 5.0.
次要结局
未报告次要终点
研究者
Bree Eaton
Principal Investigator
Emory University