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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
State of Vienna
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Vienna、State of Vienna、オーストリア、1090
- 募集
- AKH Vienna, Department for Internal Medicine I, Oncology
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コンタクト：
- Marika Rosner
- 電話番号：44450 +43140400
- メール：marika.rosner@meduniwien.ac.at
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コンタクト：
- Anna Berghoff, MD
- 電話番号：44450 +43140400
- メール：anna.berghoff@meduniwien.ac.at
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：ex vivo drug screening
Patients will receive in addition to standard histology analysis also the PDC-based drug screening.
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The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of patients
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PDC-based drug screening
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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Assess the progression free 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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Geriatric screening tools
時間枠：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 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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2028年1月1日
研究の完了 (推定)
2029年1月1日
試験登録日
最初に提出
2026年4月9日
QC基準を満たした最初の提出物
2026年5月31日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年5月31日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ATTRACTION
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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