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Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial In Patients Scheduled for shOrt Course radiatioN (ATTRACTION)

31 maj 2026 uppdaterad av: Anna Berghoff, Medical University of Vienna
Patients will receive in addition to standard histology analysis also the PDC- based drug screening.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: ex vivo drug screening
Patients will receive in addition to standard histology analysis also the PDC-based drug screening.
Diagnostiskt test: CBmed drug screening platform
The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of patients
Tidsram: 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)
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PDC-based drug screening
Tidsram: 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)
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
Quality of life assessment
Tidsram: 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
Quality of life assessment based on verified questionnaires
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
Neurocognitive function
Tidsram: 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)
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
Overall survival
Tidsram: 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
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
Progression free survival
Tidsram: 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
Geriatric screening tools
Tidsram: 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.
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Medical University of Vienna

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 januari 2028

Avslutad studie (Beräknad)

1 januari 2029

Studieregistreringsdatum

Först inskickad

9 april 2026

Först inskickad som uppfyllde QC-kriterierna

31 maj 2026

Första postat (Faktisk)

4 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ATTRACTION

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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