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Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation

2021年1月3日 更新者：Shannon MacDonald, MD、Massachusetts General Hospital

Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children

This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation.

The radiation involved in this study is:

-Proton Radiation

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This research study is a Pilot Study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. This is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation.

The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this specific disease but it has been approved for other uses.

In this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. The standard of care for this procedure is photon radiation, which is very similar to proton radiation. The investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

研究类型

介入性

注册 (预期的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02214
        • 招聘中
        • Massachusetts General Hospital
        • 接触：
        • 首席研究员：
          • Shannon MacDonald, MD
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • MD Anderson Cancer Center
        • 接触：
        • 首席研究员：
          • Susan McGovern, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

3年 至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age ≥ 3 years and ≤ 18 years at the time of registration
  • Histologically proven malignancy necessitating cranio-spinal irradiation. This will include patients with a diagnosis of medulloblastoma, Supratentorial primitive neuroectodermal tumor (SPNET), germ cell tumor (GCT), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR), Atypical Teratoid/Rhabdoid Tumor (ATRT), and disseminated low-grade glioma (LGG).
  • Life expectancy ≥ 12 months.
  • Signed informed consent document and assent when appropriate.
  • HGB of > 10 g/L and PLT count > 80 K/uL

Exclusion Criteria:

  • Any prior therapeutic radiation therapy > 500 cGy has been delivered.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 5 years and are deemed by the investigator to be a low-risk for recurrence of that malignancy; or, have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin.
  • Any major uncontrolled or poorly controlled intercurrent 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.
  • Patients that receive concurrent chemotherapy with the exception of concurrent Vincristine.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Proton Radiotherapy
  • Patients will be treated with Proton Beam once daily 5 days per week.
  • Doses will be prescribed such that maximum possible coverage is achieved
辐射：Proton Beam
precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Feasibility of cranio-spinal irradiation (CSI) utilizing intensity-modulated proton therapy (IMPT) with pencil beam scanning (PBS) for vertebral body sparing (VBS) in pediatric patients.
大体时间：3 months
IMPT using PBS delivery will be considered to be feasible as a VBS technique for CSI in pediatric patients if the rate of grade 3/4 hematologic toxicity were no more than 5% within 3 months after the completion of radiation treatment, within the range associated with conventional techniques of CSI. Toxicity will be assess using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
3 months

次要结果测量

结果测量
措施说明
大体时间
Early marrow changes in the vertebral bodies
大体时间：2 years
Summary of early marrow changes in the vertebral bodies by Magnetic resonance imaging (MRI) of the spine during radiation therapy (RT) by comparing one study MRI to the baseline pre-RT MRI.
2 years
Vertebral column growth (measured by MRI) over 5 years
大体时间：Annually for 5 years
Summary of vertebral column growth (measured by MRI) over 5 years following vertebral body sparing cranio-spinal irradiation in pediatric patients.
Annually for 5 years
Change in sitting height and standing height
大体时间：Annually for 5 years
Summary of the changes in the participants sitting and standing heights.
Annually for 5 years
Time to abnormality in spinal curvature
大体时间：5 years
Participants are monitored both clinically and by MRI for any abnormality in spinal curvature. The time to abnormality in spine curvature will be measured from the start of radiation to the date of documented abnormality or censored at the date of last follow-up for patients still alive with normal spine.
5 years
Disease Free Survival
大体时间：5 years
Disease-free survival is measured from the start of radiation to the date of progressive disease based on imaging studies obtained as standard care or to the date of death due to any cause, whichever is earlier. Disease-free survival will be estimated using the Kaplan-Meier method. Patients without progressive disease and still alive will be censored at their date of last contact.
5 years
Pattern of Disease Relapse
大体时间：2 years
Summary of the sites where the cancer relapses. Relapse is the regrowth of cancer cells.
2 years
Complete blood counts (CBC) over time
大体时间：Annually for 5 years
Summary of the change in complete blood counts (CBC) over time as determined by yearly blood samples.
Annually for 5 years
Change in levels of vitamin D, calcium, and growth hormones over time
大体时间：Annually for 5 years
Summary of the changes in blood levels of vitamin D, calcium, and growth hormones.
Annually for 5 years
Weight
大体时间：Annually for 5 years
Summary of the changes in weight of the participants as assessed by yearly evaluations.
Annually for 5 years
BMI
大体时间：Annually for 5 years
Summary of the body mass index (BMI) of the participants as assessed by yearly physical evaluations.
Annually for 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Massachusetts General Hospital

合作者

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Shannon MacDonald, MD、Massachusetts General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月4日

初级完成 (预期的)

2022年3月31日

研究完成 (预期的)

2025年3月31日

研究注册日期

首次提交

2017年9月8日

首先提交符合 QC 标准的

2017年9月11日

首次发布 (实际的)

2017年9月13日

研究记录更新

最后更新发布 (实际的)

2021年1月5日

上次提交的符合 QC 标准的更新

2021年1月3日

最后验证

2021年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 17-283
  • U19CA021239-37 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Proton Beam的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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