此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Phase-1 Trial to Investigate the Use of Pulsed Low-dose Rate Radiotherapy in Diffuse Midline Gliomas. (BABY-PULSAR)

2026年10月29日 更新者：Centro di Riferimento Oncologico - Aviano

Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Pulsed low-dose-rate radiotherapy (pLDRT) may offer additional advantages by further reducing treatment-related toxicity, preserving tumor vascularization to facilitate the delivery and efficacy of subsequent chemotherapy, and exploiting the low-dose hyper-radiosensitivity phenomenon. To the best of our knowledge, no clinical studies have evaluated pLDRT in patients with DMG. Therefore, the primary objective of this phase I study is to evaluate the tolerability of pLDRT in this predominantly pediatric population and to determine a safe dose level for future clinical investigation.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Pulsed low-dose-rate radiotherapy (pLDRT) may offer additional advantages by further reducing treatment-related toxicity, preserving tumor vascularization to facilitate the delivery and efficacy of subsequent chemotherapy, and exploiting the low-dose hyper-radiosensitivity phenomenon. To the best of our knowledge, no clinical studies have evaluated pLDRT in patients with DMG. Therefore, the primary objective of this phase I study is to evaluate the tolerability of pLDRT in this predominantly pediatric population and to determine a safe dose level for future clinical investigation.

研究类型

介入性

注册 (估计的)

12

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

  • 姓名：Elisa Coassin, MD
  • 电话号码：+39 0434 659632
  • 邮箱：ecoassin@cro.it

学习地点

  • 意大利
    • Pordenone
      • Aviano、Pordenone、意大利、33081
        • 招聘中
        • Centro di Riferimento Oncolgico -IRCCS
        • 接触：
        • 首席研究员：
          • Elisa Coassin

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

1秒 至 100年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Radiological and/or histological diagnosis of diffuse midline glioma (DMG).
  • Ability to maintain the treatment position or undergo sedation, if required.
  • Written informed consent provided by the parent(s) or legal guardian(s), or by the patient if aged ≥18 years.

Exclusion Criteria:

  • Refusal to undergo radiotherapy (i.e., lack of signed informed consent).
  • Concurrent chemotherapy.
  • Leptomeningeal dissemination of disease.
  • Ongoing pregnancy (for post-pubertal female patients).
  • Previous radiotherapy to the brainstem.

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：Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
辐射：Pulsed Low-Dose-Rate Radiotherapy, pLDRT

The radiotherapy treatment will preferably be delivered using volumetric modulated arc therapy (VMAT) with high-energy photons (6 MV), including 6 MV flattening filter-free (FFF) beams when appropriate. In selected cases, intensity-modulated radiotherapy (IMRT) may be used.

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
Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
大体时间：Up to 5 years

Incidence of grade ≥3 toxicities, as defined according to the CTCAE v5.0 scale
Up to 5 years

次要结果测量

结果测量
措施说明
大体时间
To evaluate the median time to local disease progression.
大体时间：Up to 5 years

Median progression-free survival (PFS) defined as the time from treatment initiation to the first documented disease progression or death from any cause. Disease progression will be defined according to the RAPNO criteria for pediatric patients and the RANO criteria for adult patients.
Up to 5 years
To evaluate median overall survival.
大体时间：Up to 5 years

Median overall survival (OS), defined as the time from treatment initiation to death from any cause.
Up to 5 years
To assess the incidence of treatment-related toxicities other than dose-limiting toxicities.
大体时间：Up to 5 years

Frequency of neurological toxicities
Up to 5 years
To assess changes in neurological symptoms compared with baseline.
大体时间：Up to 5 years

Change in frequencies of neurological symptoms
Up to 5 years
To evaluate corticosteroid use during radiotherapy.
大体时间：Up to 5 years

Dexamethasone dose (mg/day) mean
Up to 5 years
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
大体时间：Up to 5 years

Relation between PFS (defined as the time from treatment initiation to the first documented disease progression or death from any cause) and levels of circulating biomarkers will be evaluated with Kaplan-Meyer method
Up to 5 years
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
大体时间：Up to 5 years

Relation between OS (defined as the time from treatment initiation to death from any cause) and levels of circulating biomarkers will be evaluated with Kaplan-Meyer method
Up to 5 years
To evaluate tissue biomarkers of response to pLDRT.
大体时间：Up to 5 years

Relation between PFS (defined as the time from treatment initiation to the first documented disease progression or death from any cause) and levels of tissue biomarkers will be evaluated with Kaplan-Meyer method
Up to 5 years
To evaluate tissue biomarkers of response to pLDRT.
大体时间：Up to 5 years

Relation between OS (defined as the time from treatment initiation to death from any cause) and levels of tissue biomarkers will be evaluated with Kaplan-Meyer method
Up to 5 years
To characterize the inflammatory and immune profile induced by the pLDRT treatment schedule.
大体时间：Up to 5 years

Mean of median levels of biomarkers of inflammatory and immune profile
Up to 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

Centro di Riferimento Oncologico - Aviano

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)

2026年5月13日

初级完成 (估计的)

2030年7月15日

研究完成 (估计的)

2030年7月15日

研究注册日期

首次提交

2026年10月29日

首先提交符合 QC 标准的

2026年10月29日

首次发布 (实际的)

2026年11月5日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CRO-2025-21

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

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.

订阅