Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial In Patients Scheduled for shOrt Course radiatioN (ATTRACTION)
2026年5月31日 更新者：Anna Berghoff、Medical University of Vienna
Patients will receive in addition to standard histology analysis also the PDC- based drug screening.
研究概览
详细说明
Patients will receive in addition to standard histology analysis also the PDC- based drug screening. The PDC-based drug screening will be performed only in accordance with the approved Performance Study Plan on subjects who have signed an informed consent form. Execution of the PDC-based drug screening is limited to the approved study investigators. Based on the results of the PDC-based drug screening, a molecular tumor board will formulate a personalized treatment approach. The personalized treatment recommendation will be communicated to the patient. Application of adjuvant
/ maintenance therapy will be evaluated to evaluate the proportion of patients scheduled for a reduced course of radio(-chemo)therapy fit enough to receive at least one day of systemic therapy.
研究类型
介入性
注册 (估计的)
30
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。
学习地点
-
-
State of Vienna
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Vienna、State of Vienna、奥地利、1090
- 招聘中
- AKH Vienna, Department for Internal Medicine I, Oncology
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接触：
- Marika Rosner
- 电话号码：44450 +43140400
- 邮箱：marika.rosner@meduniwien.ac.at
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接触：
- Anna Berghoff, MD
- 电话号码：44450 +43140400
- 邮箱：anna.berghoff@meduniwien.ac.at
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-
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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- ECOG performance status 0-2
- Newly diagnosed glioblastoma, IDH-wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System
- Unmethylated MGMT promotor per local assessment
- Successful PDC establishment and PDCs available for drug screening - based on inclusion in one of the following studies: (EK Nrs. (a) Medical University of Graz: 32-650 ex 19/20; (b) Medical University of Vienna: 1407/2021; (c) Karl Landsteiner University of Health Sciences: GS1-EK-4/823-2022; (d) Kepler University Hospital Linz: 1323/2022; (e) Medical University of Innsbruck 1003/2023) and follow-up ethics covering the establishment of an Austrian GlioBank (EK Nrs. (a) Medical University of Graz: 36-253 ex 23/24; (b) Medical University of Vienna: 2186/2023; (c) Karl Landsteiner University of Health Sciences: GS3-EK-1/211-2024; (d) Kepler University Hospital Linz: 1002/2024; (e) Medical University of Innsbruck 1095/2024)
- Scheduled short-course radiotherapy with or without concomitant temozolomide
- Written informed consent
- No exclusion criteria
Exclusion Criteria:
- Current participation in another therapeutic clinical trial.
- Patients with a concurrent malignancy or malignancy within five years of study enrolment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma or stage I uterine cancer within the last 3 years.
- Pregnant or lactating women.
- Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection are eligible. Patients positive for anti-HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥350 cells/mm3, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended.
- Participants who are unable or unwilling to comply with the requirements of the protocol as assessed by the investigator.
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：其他
- 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 |
|---|---|
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其他：ex vivo drug screening
Patients will receive in addition to standard histology analysis also the PDC-based drug screening.
|
The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics
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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 |
|---|---|---|
|
Percentage of patients
大体时间：From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
Percentage of patients receiving at least one day of maintenance systemic therapy in the timeframe of 4-6 weeks after completion of a short course radio(-chemo)therapy (40 Gy in 15 fractions)
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From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PDC-based drug screening
大体时间：From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
Assess feasibility of a PDC-based drug screening approach in a multi-center study hroughout Austria and within the timeframe short course radio(-chemo)therapy (40 Gy in 15 fractions)
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From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
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Quality of life assessment
大体时间：From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
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Quality of life assessment based on verified questionnaires
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From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
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Neurocognitive function
大体时间：From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
Assess the neurocognitive function using the NANO scale (neurological assessment in neuro- oncology)
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From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
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Overall survival
大体时间：From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
Assess the overall survival
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From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
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Progression free survival
大体时间：From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
Assess the progression free survival
|
From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
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Geriatric screening tools
大体时间：From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
|
Geriatric vulnerability will be assessed using the Geriatric-8 (G8) and Vulnerable Elders Survey 13 (VES-13) screening tools.
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From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 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。
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 (估计的)
2026年6月1日
初级完成 (估计的)
2028年1月1日
研究完成 (估计的)
2029年1月1日
研究注册日期
首次提交
2026年4月9日
首先提交符合 QC 标准的
2026年5月31日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年5月31日
最后验证
2026年5月1日
更多信息
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.