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立即从GBM切除与护理标准开始辐射。 (BRIDGES)

2026年11月5日 更新者：GT Medical Technologies, Inc.

切除和Gammatile®的随机研究，然后进行外部束放射治疗（EBRT）和替莫唑胺（TMZ）和辅助TMZ与新诊断的胶质母细胞瘤（GBM）的护理标准

This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows:

  • A Screening/Baseline Period of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B.
  • A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B).
  • An EBRT Prior to Start Period. This occurs within 10 business days prior to EBRT and Concurrent TMZ Phase.
  • An EBRT and Concurrent TMZ Phase, which will begin 30 ±10 days post-surgery. EBRT (30 fractions) and TMZ will be administered up to 5 days a week for 6 weeks in Arm A, and EBRT (20 fractions) and TMZ will be administered for up to 5 days a week for 4 weeks in Arm B. TMZ will be administered at a dose of 75 mg/m2/day orally for each Arm.
  • An Adjuvant TMZ Phase, which begins 28 ±7 days following the EBRT and Concurrent TMZ Phase, and is comprised of six 28-day cycles. TMZ (150-200 mg/m2/day orally) will be administered for the first 5 days of each 28-day cycle for each Arm. Tumor treating fields are allowed but are not mandated during this phase. Up to 6 additional cycles (for a total of 12) can be completed at the discretion of the Investigator.
  • An Early Discontinuation/Follow-Up Phase will occur 28 ±7 days after completion of Cycle 6 of the Adjuvant TMZ Phase, regardless of the total number of cycles completed or any delays in cycle start. If fewer than six cycles are completed, the first follow-up assessment will occur 28 ±7 days after the last administered dose of adjuvant TMZ. If patient has a qualifying event requiring entrance to Early Discontinuation Phase, the first follow-up assessment will occur as soon as feasible, but within 28 days.

For any unscheduled visits, data collected should be documented in the case report form (CRF) and must include, but are not limited to, safety evaluations, survival status, and disease status.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

766

阶段

  • 第三阶段

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
    • Arizona
      • Scottsdale、Arizona、美国、85251
        • 招聘中
        • HonorHealth Scottsdale Osborn Medical Center
        • 首席研究员：
          • John Wanebo, MD
        • 接触：
    • California
      • Los Angeles、California、美国、90048
        • 招聘中
        • Cedars Sinai Medical Center
        • 接触：
          • Jeremy D. Rudnick, MD
        • 首席研究员：
          • Jeremy D. Rudnick, MD
      • Los Angeles、California、美国、90033
        • 招聘中
        • Keck Medicine of USC
        • 首席研究员：
          • Eric Chang, MD
        • 接触：
      • San Francisco、California、美国、94115
        • 招聘中
        • Sutter Health
        • 接触：
          • Patricia Seid, MD
        • 首席研究员：
          • Patricia Seid, MD
      • San Francisco、California、美国、94143
        • 招聘中
        • University of California San Fransico
        • 接触：
          • Jacob Young, MD
        • 首席研究员：
          • Jacob Young, MD
    • Colorado
      • Littleton、Colorado、美国、80122
        • 招聘中
        • Advent Health - Colorado
        • 接触：
          • Darlene Bugoci, MD
        • 首席研究员：
          • Darlene Bugoci, MD
    • Florida
      • Orlando、Florida、美国、32804
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 招聘中
        • Emory Winship Cancer Institute
        • 接触：
        • 首席研究员：
          • Kimberly B. Hoang, MD
    • Illinois
      • Chicago、Illinois、美国、60607
        • 招聘中
        • Rush University Medical Center
        • 首席研究员：
          • Ken Tatebe, MD, PhD
        • 接触：
          • Ken Tatebe, MD, PhD
    • Kentucky
      • Louisville、Kentucky、美国、40241
        • 招聘中
        • Norton Cancer Institute - Brownsboro
        • 首席研究员：
          • Parag Sevak, MD
        • 接触：
          • Parag Sevak, MD
    • Maryland
      • Baltimore、Maryland、美国、21287
        • 招聘中
        • Johns Hopkins University
        • 接触：
          • Jordina Rincon-Torroella, MD
          • 电话号码：410-955-1040
          • 邮箱：jrincon2@jhmi.edu
        • 首席研究员：
          • Jordina Rincon-Torroella, MD
    • Missouri
      • Columbia、Missouri、美国、65201
        • 招聘中
        • University of Missouri
        • 接触：
          • Gregory Biedermann, MD
        • 首席研究员：
          • Gregory B. Biedermann, MD
    • New Hampshire
      • Lebanon、New Hampshire、美国、03766
    • New Jersey
      • Neptune City、New Jersey、美国、07753
        • 招聘中
        • Jersey Shore University Medical Center | Hackensack
        • 首席研究员：
          • Nitesh Patel, MD
        • 接触：
    • New York
      • Valhalla、New York、美国、10595
        • 招聘中
        • Westchester Medical Center
        • 首席研究员：
          • Simon Hanft, MD
        • 接触：
        • 副研究员：
          • Rohil Shekher, MD
    • North Carolina
      • Greenville、North Carolina、美国、27834
        • 招聘中
        • East Carolina University
        • 首席研究员：
          • K. Stuart Lee, MD
        • 接触：
    • Ohio
      • Columbus、Ohio、美国、43210
        • 招聘中
        • The Ohio State University
        • 首席研究员：
          • James B Elder, MD
        • 接触：
          • James B Elder, MD
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15212
        • 招聘中
        • Allegheny Health Network
        • 首席研究员：
          • Matthew Shepard, MD
        • 接触：
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • 招聘中
        • Brown University Health
        • 首席研究员：
          • Clark Chen, MD, PhD
        • 接触：
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • 招聘中
        • Medical University of South Carolina
        • 首席研究员：
          • Charlotte Rivers, MD
        • 接触：
    • Texas
      • Houston、Texas、美国、77030
    • Virginia
      • Fairfax、Virginia、美国、22031
        • 招聘中
        • Inova Schar Cancer Institute
        • 接触：
          • Kevin Choe, MD, PhD
        • 首席研究员：
          • Kevin Choe, MD, PhD

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

18年 及以上 (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

Major Criteria Includes the Following:

Inclusion Criteria

  • Patients must be ≥18 years of age.

  • Have radiographic suspicion of newly diagnosed glioblastoma (GBM).

    o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL measures but will not be included in the primary and secondary comparative survival and efficacy analyses.

  • Are medically and surgically appropriate for resection.

  • Have an estimated Karnofsky Performance Scale (KPS) score of ≥70.

  • Are able to receive standard of care treatment.

Exclusion Criteria

  • A previous biopsy diagnosis other than IDH wild-type GBM.
  • Have contraindications to TMZ, magnetic resonance imaging, gadolinium, or non-contrast computed tomography.
  • Have multi-focal enhancing tumors that cannot be encompassed in one operative field.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Maximal safe resection followed by EBRT with concurrent TMZ followed by adjuvant TMZ (Arm A)

All patients will undergo tumor resection. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 30-fraction course of EBRT for 6 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles.
辐射：External Beam Radiation Therapy

External beam radiation therapy (EBRT) is a type of radiation therapy that is standard of care. EBRT uses a machine outside the body to deliver high-energy beams of radiation to cancerous areas within the body

其他名称：
  • EBRT
药品：Temozolomide

TMZ (Chemotherapy) is used as a first-line treatment, often in combination with radiation therapy after surgical resection of the tumor

其他名称：
  • TMZ
实验性的：Maximal safe resection + GammaTile followed by EBRT with concurrent TMZ then adjuvant TMZ (Arm B)

All patients will undergo tumor resection + GammaTile implantation. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 20-fraction course of EBRT for 4 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles.
辐射：External Beam Radiation Therapy

External beam radiation therapy (EBRT) is a type of radiation therapy that is standard of care. EBRT uses a machine outside the body to deliver high-energy beams of radiation to cancerous areas within the body

其他名称：
  • EBRT
药品：Temozolomide

TMZ (Chemotherapy) is used as a first-line treatment, often in combination with radiation therapy after surgical resection of the tumor

其他名称：
  • TMZ
设备：GammaTile®

GammaTiles are a U.S. FDA-cleared, surgically targeted radiation therapy for patients with certain brain tumors. GammaTile consists of bioresorbable collagen tiles embedded with Cesium-131 (Cs-131) radioactive seeds

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
Overall Survival
大体时间：Days from surgery to death.

The primary endpoint of the study is OS, defined as the day from surgery to death. Patients who are still alive (or lost to follow-up) at the time of data analysis will be censored at the last time point they were known to be alive.
Days from surgery to death.

次要结果测量

结果测量
措施说明
大体时间
Progression Free Survival
大体时间：Days from surgery to death or disease progression.

To compare PFS, defined as days from surgery to death or disease progression, between the 2 study arms based on the most current RANO Resect Group criteria;
Days from surgery to death or disease progression.
Time to next unplanned treatment
大体时间：Time to next unplanned treatment.

To compare the time to next unplanned treatment per study arm
Time to next unplanned treatment.
Performance Status
大体时间：24 months.

To assess the performance status up to 24 months
24 months.
Safety Assessment
大体时间：Study duration.

To assess the nature, severity, and frequency of AEs between the 2 study arms based on the most current CTCAE criteria
Study duration.
Quality of Life Assessments
大体时间：COST-Score duration of study; FACT-Br up to 12 months after randomization.

Financial toxicity scale (Comprehensive Score for Financial Toxicity [COST]-score) and functional assessment of cancer therapy - brain (FACT-Br) up to 12 months after randomization.
COST-Score duration of study; FACT-Br up to 12 months after randomization.

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

GT Medical Technologies, Inc.

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)

2025年12月10日

初级完成 (估计的)

2031年12月1日

研究完成 (估计的)

2031年12月1日

研究注册日期

首次提交

2025年9月10日

首先提交符合 QC 标准的

2025年9月19日

首次发布 (实际的)

2025年9月26日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11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

  • GTM-105

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.

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