Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial In Patients Scheduled for shOrt Course radiatioN (ATTRACTION)
31 de mayo de 2026 actualizado por: Anna Berghoff, Medical University of Vienna
Patients will receive in addition to standard histology analysis also the PDC- based drug screening.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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State of Vienna
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Vienna, State of Vienna, Austria, 1090
- Reclutamiento
- AKH Vienna, Department for Internal Medicine I, Oncology
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Contacto:
- Marika Rosner
- Número de teléfono: 44450 +43140400
- Correo electrónico: marika.rosner@meduniwien.ac.at
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Contacto:
- Anna Berghoff, MD
- Número de teléfono: 44450 +43140400
- Correo electrónico: anna.berghoff@meduniwien.ac.at
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of patients
Periodo de tiempo: 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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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PDC-based drug screening
Periodo de tiempo: 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 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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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
Periodo de tiempo: 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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de enero de 2028
Finalización del estudio (Estimado)
1 de enero de 2029
Fechas de registro del estudio
Enviado por primera vez
9 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ATTRACTION
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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