- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00967330
A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Aachen, Alemanha, 52074
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Berlin, Alemanha, 13353
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Bochum, Alemanha, 44892
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Bonn, Alemanha, 53127
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Chemnitz, Alemanha, 09113
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Dresden, Alemanha, 01307
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Düsseldorf, Alemanha, 40225
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Erfurt, Alemanha, 99089
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Erlangen, Alemanha, 91054
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Frankfurt am Main, Alemanha, 60528
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Freiburg, Alemanha, 79106
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Göttingen, Alemanha, 37075
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Idar-Oberstein, Alemanha, 55743
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Kiel, Alemanha, 24105
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Köln, Alemanha, 50937
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Leipzig, Alemanha, 04103
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Mannheim, Alemanha, 68167
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Marburg, Alemanha, 35043
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Muenchen, Alemanha, 81377
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München, Alemanha, 81675
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Münster, Alemanha, 48149
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Regensburg, Alemanha, 93053
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Tübingen, Alemanha, 72076
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Ulm, Alemanha, 89081
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- adult patients, 18-70 years of age;
- glioblastoma, confirmed histologically;
- no previous chemotherapy or radiotherapy for glioblastoma;
- non-methylated MGMT promoter in the tumor.
Exclusion Criteria:
- prior systemic treatment for glioblastoma multiforme;
- prior treatment with Avastin;
- significant cardiovascular disease;
- other active malignant disease.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 1
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10mg/kg iv every 2 weeks
125mg/m2 iv every 2 weeks
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Comparador Ativo: 2
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75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months
Prazo: 6 months
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Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first.
Progression was defined as 25 percent (%) increase in size of enhancing tumor or any new tumor on gadolinium contrast agent magnetic resonance imaging (Gd-MRI) scans, or neurologically worse, and steroids stable or increased.
Percentage of participants achieving PFS without disease progression or death was reported.
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Progression-Free Survival (PFS)
Prazo: From baseline to the end of the study (up to 4.5 years)
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Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first.
Progression was defined as 25% increase in size of enhancing tumor or any new tumor on Gd-MRI scans, or neurologically worse, and steroids stable or increased.
PFS was estimated using Kaplan-Meier method.
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From baseline to the end of the study (up to 4.5 years)
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Overall Survival (OS)
Prazo: From baseline until death (up to 4.5 years)
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Overall survival was defined as the time from randomization to death from any cause.
OS was estimated using Kaplan-Meier method.
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From baseline until death (up to 4.5 years)
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Percentage of Participants Who Discontinued
Prazo: From baseline until death (up to 4.5 years)
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Discontinuation was defined as the percentage of participants who permanently discontinued treatment in either treatment arm.
Percentage of participant with individual discontinuation reason are reported.
CNS: central nervous system; CTCAE: Common Terminology Criteria for Adverse Events .
Other reason refers to any other reason than the specified ones.
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From baseline until death (up to 4.5 years)
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Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR)
Prazo: 4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6
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BOR was defined as the best response observed for a participant during assessment.
Number of participants who had BOR as CR and number of participants who had BOR as CR or PR were reported.
Complete response was defined as disappearance of all enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, off steroids, and neurologically stable or improved.
Partial response was defined as 50% reduction in size of enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved.
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4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6
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Percentage of Participants With Response on FLAIR Imaging
Prazo: At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years)
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FLAIR lesions were determined as "stable", "progressive" or "decreased". FLAIR lesions was determined as "progressive" only if they were not be attributed to causes apart from tumor infiltration (sequelae of radiation therapy, demyelination, ischemia, infection, seizures, or other treatment effects). Percentage of participants are based on ITT population. Dis.=Discontinuation. |
At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years)
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30)
Prazo: Baseline, Post-Baseline (up to Month 30)
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The EORTC QLQ-C30 incorporates: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale.
Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent').
Scores were averaged and transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of functioning or a higher score for symptom scale=greater degree of symptoms.
The change in global health status was determined to be the difference in values at baseline and each specific visit.
The term ''baseline'' refers to the time of randomization to the maintenance phase.
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Baseline, Post-Baseline (up to Month 30)
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Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30)
Prazo: Baseline, Post-Baseline (up to Month 30)
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EORTC QLQ-BN20 consisted of 20 items assessing visual disorders, motor dysfunction, communication deficit, various disease symptoms (e.g.
headaches and seizures), treatment toxicities (e.g.
hair loss) and future uncertainty.
All of the 20 items are rated on a 4 point Likert scale from 1=not at all, 2=a little, 3=quite a bit and 4=very much, and were linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.
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Baseline, Post-Baseline (up to Month 30)
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Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30)
Prazo: Baseline, Post-Baseline (up to Month 30)
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The MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language and construct ability.
Each area tested had a designated point value, the total score can range from 0 to 30, with a higher score indicating better function.
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Baseline, Post-Baseline (up to Month 30)
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Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30)
Prazo: Baseline, Post-Baseline (up to Month 30)
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KPS is an 11-level score (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100) which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks.
Deterioration in KPS was defined as decrease of 20 or more points in KPS score.
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Baseline, Post-Baseline (up to Month 30)
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Percentage of Participants Who Received Corticosteroid for Glioblastoma
Prazo: From baseline to Month 6
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Participants used corticosteroids for the glioblastoma condition.
Corticosteroids included dexamethasone, methylprednisone, fortecortin, hydrocortisone, urbason, and prednisolone.
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From baseline to Month 6
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Time to Treatment Failure
Prazo: From baseline until end of study (up to 4.5 years)
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From baseline until end of study (up to 4.5 years)
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Schafer N, Proescholdt M, Steinbach JP, Weyerbrock A, Hau P, Grauer O, Goldbrunner R, Friedrich F, Rohde V, Ringel F, Schlegel U, Sabel M, Ronellenfitsch MW, Uhl M, Grau S, Hanel M, Schnell O, Krex D, Vajkoczy P, Tabatabai G, Mack F, Schaub C, Tzaridis T, Niessen M, Kebir S, Leutgeb B, Urbach H, Belka C, Stummer W, Glas M, Herrlinger U. Quality of life in the GLARIUS trial randomizing bevacizumab/irinotecan versus temozolomide in newly diagnosed, MGMT-nonmethylated glioblastoma. Neuro Oncol. 2018 Jun 18;20(7):975-985. doi: 10.1093/neuonc/nox204.
- Herrlinger U, Schafer N, Steinbach JP, Weyerbrock A, Hau P, Goldbrunner R, Friedrich F, Rohde V, Ringel F, Schlegel U, Sabel M, Ronellenfitsch MW, Uhl M, Maciaczyk J, Grau S, Schnell O, Hanel M, Krex D, Vajkoczy P, Gerlach R, Kortmann RD, Mehdorn M, Tuttenberg J, Mayer-Steinacker R, Fietkau R, Brehmer S, Mack F, Stuplich M, Kebir S, Kohnen R, Dunkl E, Leutgeb B, Proescholdt M, Pietsch T, Urbach H, Belka C, Stummer W, Glas M. Bevacizumab Plus Irinotecan Versus Temozolomide in Newly Diagnosed O6-Methylguanine-DNA Methyltransferase Nonmethylated Glioblastoma: The Randomized GLARIUS Trial. J Clin Oncol. 2016 May 10;34(14):1611-9. doi: 10.1200/JCO.2015.63.4691. Epub 2016 Mar 14.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias Glandulares e Epiteliais
- Astrocitoma
- Glioma
- Neoplasias Neuroepiteliais
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Glioblastoma
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Agentes Antineoplásicos Alquilantes
- Agentes Alquilantes
- Inibidores da Topoisomerase
- Agentes Antineoplásicos Imunológicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Inibidores da Topoisomerase I
- Temozolomida
- Bevacizumabe
- Irinotecano
Outros números de identificação do estudo
- ML21965
- 2009-010390-21
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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