Advanced Imaging-Guided Standard Versus Dose-Intensified Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma, SAGA 2.0 Trial
Stereotactic Advanced-Imaging Guided Radiotherapy for Glioblastoma (SAGA 2.0)
This clinical trial studies how well advanced imaging-guided standard dose versus (vs.) dose-intensified radiation therapy (RT) and dose-intensified accelerated RT works in treating patients with newly diagnosed glioblastoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. During dose-intensified RT, a higher dose than normal of radiation therapy is delivered over 6 weeks. During dose-intensified accelerated RT, the higher dose of radiation therapy is delivered over a shorter amount of time (2 weeks) than normal (6 weeks). Patients also undergo an advanced brain imaging positron emission tomography (PET)/computed tomography (CT) scan (using a radioactive drug called either FET or FDOPA) prior to RT to that may help doctors better plan the treatment. Dose-intensified and dose-intensified accelerated radiation therapy may be effective in treating patients with newly diagnosed glioblastoma. Giving dose-intensified RT or dose-intensified accelerated RT guided by advanced imaging may work better than standard dose RT in treating patients with newly diagnosed glioblastoma.
IND Numbers: 61300, 140882, 176402, 154793, 167879
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
- Procedimento: Biospecimen Collection
- Procedimento: Magnetic Resonance Imaging
- Outro: Questionnaire Administration
- Procedimento: Computed Tomography
- Radiação: F-18 Fluoroethyltyrosine
- Medicamento: Fluorodopa F 18
- Radiação: Dose-intensified Photon Beam Radiation Therapy
- Procedimento: Positron Emission Tomography
- Radiação: Proton Beam Radiation Therapy
- Radiação: Proton Beam Radiation Therapy
- Radiação: Proton Beam Radiation Therapy
- Radiação: Proton Beam Radiation Therapy
- Medicamento: Temozolomide
- Radiação: Standard Photon Beam Radiation Therapy
- Radiação: Dose-intensified Accelerated Photon Beam Radiation Therapy
- Radiação: Accelerated Photon Beam Radiation Therapy
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259
- Mayo Clinic in Arizona
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Investigador principal:
- Sujay A. Vora
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Contato:
- Sujay A. Vora
- Número de telefone: 480-342-2000
- E-mail: vora.sujay@mayo.edu
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Florida
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Jacksonville, Florida, Estados Unidos, 32224-9980
- Mayo Clinic in Florida
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Investigador principal:
- Daniel Trifiletti
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Contato:
- Daniel Trifiletti
- Número de telefone: 904-953-2000
- E-mail: trifiletti.daniel@mayo.edu
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Minnesota
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Albert Lea, Minnesota, Estados Unidos, 56007
- Mayo Clinic Health System in Albert Lea
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Contato:
- John E. Yeakel
- Número de telefone: 507-668-2063
- E-mail: yeakel.john@mayo.edu
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Investigador principal:
- John E. Yeakel
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Mankato, Minnesota, Estados Unidos, 56001
- Mayo Clinic Health Systems-Mankato
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Contato:
- Jason T. Hayes
- Número de telefone: 507-668-2063
- E-mail: hayes.jason@mayo.edu
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Investigador principal:
- Jason T. Hayes
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic in Rochester
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Contato:
- William Breen
- Número de telefone: 507-284-3261
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Investigador principal:
- William Breen
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Wisconsin
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Eau Claire, Wisconsin, Estados Unidos, 54701
- Mayo Clinic Health System-Eau Claire Clinic
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Contato:
- Now Bahar Alam
- Número de telefone: 715-464-8124
- E-mail: alam.nowbahar@mayo.edu
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Investigador principal:
- Now Bahar Alam
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La Crosse, Wisconsin, Estados Unidos, 54601
- Mayo Clinic Health System-Franciscan Healthcare
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Contato:
- Abigail L. Stockham
- Número de telefone: 608-392-7332
- E-mail: stockham.abigail@mayo.edu
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Investigador principal:
- Abigail L. Stockham
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age ≥ 18 years
- Histological confirmation of glioblastoma (IDH-wildtype)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 3 at baseline
- Provide written informed consent or have a Legally Authorized Representative (LAR) who is responsible for the care and well-being of the potential study participant, provide consent in accordance with ethical, regulatory, and institutional requirements
- Willing to return to enrolling institution for follow-up either in-person or by video visit (where indicated)
Exclusion Criteria:
- Known to be pregnant or nursing
- Unable to undergo MRI scans with contrast (such as patients with devices or metal in head that is MRI incompatible)
- Unable to undergo amino acid PET (FET or FDOPA) scan (such as allergy to the contrast/tracer, or technical or patient factors per the discretion of the treating physician)
- Prior radiation (including tile-based brachytherapy) or chemotherapy for glioblastoma (note: prior cancer diagnoses and treatment for other cancers are not exclusion criteria, and multiple surgeries prior to enrollment is not an exclusion criteria)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: Arm A (dose-intensified radiation therapy)
Patients undergo thirty treatment fractions of dose-intensified proton or photon radiation therapy QD (Monday-Friday) over 6 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI and blood sample collection throughout the study. |
Undergo blood sample collection
Outros nomes:
Undergo MRI
Outros nomes:
Ancillary studies Undergo FET or FDOPA PET/CT
Outros nomes:
Given via injection
Outros nomes:
Given IV
Outros nomes:
Undergo dose-intensified photon radiation therapy
Outros nomes:
Undergo FET or FDOPA PET/CT
Outros nomes:
Undergo dose-intensified proton radiation therapy
Outros nomes:
Undergo standard proton radiation therapy
Outros nomes:
Undergo dose-intensified accelerated proton radiation therapy
Outros nomes:
Undergo accelerated proton radiation therapy
Outros nomes:
Given SOC temozolomide
Outros nomes:
|
|
Comparador Ativo: Arm B (standard radiation therapy)
Patients undergo thirty treatment fractions of standard proton or photon radiation therapy QD (Monday-Friday) over 6 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI and blood sample collection throughout the study. |
Undergo blood sample collection
Outros nomes:
Undergo MRI
Outros nomes:
Ancillary studies Undergo FET or FDOPA PET/CT
Outros nomes:
Given via injection
Outros nomes:
Given IV
Outros nomes:
Undergo FET or FDOPA PET/CT
Outros nomes:
Undergo dose-intensified proton radiation therapy
Outros nomes:
Undergo standard proton radiation therapy
Outros nomes:
Undergo dose-intensified accelerated proton radiation therapy
Outros nomes:
Undergo accelerated proton radiation therapy
Outros nomes:
Given SOC temozolomide
Outros nomes:
Undergo standard photon radiation therapy
Outros nomes:
|
|
Experimental: Arm C (dose-intensified accelerated radiation therapy)
Patients undergo ten treatment fractions of dose-intensified accelerated proton or photon radiation therapy QD (Monday-Friday) over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI throughout the study. |
Undergo MRI
Outros nomes:
Undergo FET or FDOPA PET/CT
Outros nomes:
Given via injection
Outros nomes:
Given IV
Outros nomes:
Undergo FET or FDOPA PET/CT
Outros nomes:
Undergo dose-intensified proton radiation therapy
Outros nomes:
Undergo standard proton radiation therapy
Outros nomes:
Undergo dose-intensified accelerated proton radiation therapy
Outros nomes:
Undergo accelerated proton radiation therapy
Outros nomes:
Given SOC temozolomide
Outros nomes:
Undergo dose-intensified accelerated photon radiation therapy
Outros nomes:
|
|
Comparador Ativo: Arm D (accelerated radiation therapy)
Patients undergo ten treatment fractions of accelerated proton or photon radiation therapy QD (Monday-Friday) over 2 weeks in the absence of unacceptable toxicity. Patients may also receive SOC temozolomide during and/or after radiation therapy at the discretion of the treating team. Additionally, patients receive FET via injection or FDOPA IV and undergo PET/CT prior to treatment and optionally during treatment and follow-up. Patients also undergo MRI throughout the study. |
Undergo MRI
Outros nomes:
Undergo FET or FDOPA PET/CT
Outros nomes:
Given via injection
Outros nomes:
Given IV
Outros nomes:
Undergo FET or FDOPA PET/CT
Outros nomes:
Undergo dose-intensified proton radiation therapy
Outros nomes:
Undergo standard proton radiation therapy
Outros nomes:
Undergo dose-intensified accelerated proton radiation therapy
Outros nomes:
Undergo accelerated proton radiation therapy
Outros nomes:
Given SOC temozolomide
Outros nomes:
Undergo accelerated photon radiation therapy
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall survival (Cohort 1)
Prazo: Up to 18 months
|
Overall survival (OS) is defined as the time from registration until death due to any cause. Will be summarized by treatment arm using the difference in proportions test. |
Up to 18 months
|
|
Overall survival (Cohort 2)
Prazo: Up to 12 months
|
Overall survival (OS) is defined as the time from registration until death due to any cause. A Bayesian pick-the-winner design will be used to identify the more promising treatment arm based on 12-month overall survival. |
Up to 12 months
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of grade 3+ central nervous system (CNS) toxicity, regardless of attribution (Overall CNS toxicity)
Prazo: Up to 36 months post-radiation therapy (RT)
|
CNS toxicities will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0. For each treatment arm, CNS toxicity will be summarized as: the number and proportion of patients experiencing at least one qualifying grade ≥ 3 CNS toxicity event. Between-arm comparisons will be performed descriptively. |
Up to 36 months post-radiation therapy (RT)
|
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Incidence of grade 3+ higher CNS toxicity at least possibly attributable to radiation therapy (Treatment-related CNS toxicity)
Prazo: Up to 36 months post-RT
|
As assessed by the treating investigator. CNS toxicities will be graded according to CTCAE 5.0. Events classified as possibly, probably, or definitely related to radiation therapy will be included. For each treatment arm, CNS toxicity will be summarized as: the number and proportion of patients experiencing at least one qualifying grade ≥ 3 CNS toxicity event. |
Up to 36 months post-RT
|
|
Quality of life (Cohort 1) - EORTC QLQ-C30
Prazo: Up to 6 months post-RT
|
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 is a 30-item questionnaire a questionnaire used to assess the quality of life of cancer patients. Twenty-eight questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much), and two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life. |
Up to 6 months post-RT
|
|
Quality of life (Cohort 1) - EORTC QLQ-BN20
Prazo: Up to 6 months post-RT
|
The EORTC QLQ-BN20 is a 20-item questionnaire related to symptoms experienced by patients with brain cancer during the past week. Questions are answered on a scale of 1-4 where 1=not at all, 2=a little; 3-quite a bit; and 4=very much. Higher scores indicate greater severity of symptoms. |
Up to 6 months post-RT
|
Outras medidas de resultado
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Neurocognitive outcomes (Cohort 1)
Prazo: Up to 1 month post-RT
|
As measured by Mayo Test Drive (MTD), a web-based platform for remote self-administered cognitive assessment. The primary comparison will be the between-arm difference in mean change over time (arm-by-time interaction). Higher or average composite scores indicate functioning consistent with healthy cognitive peers for participant's age, sex, and education. Significantly negative scores suggest performance drops in memory and processing. An MTD score is a screening and monitoring tool, not a medical diagnosis. Lower scores do not automatically indicate Alzheimer's or dementia; they can be influenced by other factors such as fatigue, high stress, medications, technical issues during the test, or mild age-related changes. |
Up to 1 month post-RT
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: William Breen, Mayo Clinic in Rochester
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias Glandulares e Epiteliais
- Astrocitoma
- Glioma
- Neoplasias Neuroepiteliais
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Glioblastoma
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Técnicas de investigação
- Terapêutica
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Azoles
- Fenômenos físicos
- Dacarbazina
- Triazenos
- Imidazoles
- Produtos químicos inorgânicos
- Elementos
- Técnicas de química, analíticas
- Análise de espectro
- Íons
- Eletrólitos
- Fenômenos eletromagnéticos
- Fenômenos magnéticos
- Radioterapia
- Radiação eletromagnética
- Gases
- Partículas elementares
- Luz
- Fenômenos ópticos
- Radiação, não ionizante
- Radioterapia de íons pesados
- Cátions, monovalente
- Cátions
- Hidrogênio
- Núcleos
- Temozolomida
- Radiação
- Manipulação de amostras
- Espectroscopia de ressonância magnética
- Fótons
- Fluorodopa F 18
- Terapia com prótons
- Prótons
- (18f) Fluoroetiltosina
Outros números de identificação do estudo
Outros números de identificação do estudo
- GMROR2661
- NCI-2026-07628 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 26-003443 (Outro identificador: Mayo Clinic Institutional Review Board)
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