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 maio de 2026 atualizado por: Anna Berghoff, Medical University of Vienna
Patients will receive in addition to standard histology analysis also the PDC- based drug screening.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
State of Vienna
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Vienna, State of Vienna, Áustria, 1090
- Recrutamento
- AKH Vienna, Department for Internal Medicine I, Oncology
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Contato:
- Marika Rosner
- Número de telefone: 44450 +43140400
- E-mail: marika.rosner@meduniwien.ac.at
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Contato:
- Anna Berghoff, MD
- Número de telefone: 44450 +43140400
- E-mail: anna.berghoff@meduniwien.ac.at
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of patients
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
PDC-based drug screening
Prazo: 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
Prazo: 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
Prazo: 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
|
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Overall survival
Prazo: 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
|
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Progression free survival
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
1 de janeiro de 2028
Conclusão do estudo (Estimado)
1 de janeiro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
9 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de maio de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ATTRACTION
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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