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
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
- Procedimiento: Biospecimen Collection
- Procedimiento: Magnetic Resonance Imaging
- Otro: Questionnaire Administration
- Procedimiento: Computed Tomography
- Radiación: F-18 Fluoroethyltyrosine
- Droga: Fluorodopa F 18
- Radiación: Dose-intensified Photon Beam Radiation Therapy
- Procedimiento: Positron Emission Tomography
- Radiación: Proton Beam Radiation Therapy
- Radiación: Proton Beam Radiation Therapy
- Radiación: Proton Beam Radiation Therapy
- Radiación: Proton Beam Radiation Therapy
- Droga: Temozolomide
- Radiación: Standard Photon Beam Radiation Therapy
- Radiación: Dose-intensified Accelerated Photon Beam Radiation Therapy
- Radiación: Accelerated Photon Beam Radiation Therapy
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Contacto:
- Sujay A. Vora
- Número de teléfono: 480-342-2000
- Correo electrónico: 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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Contacto:
- Daniel Trifiletti
- Número de teléfono: 904-953-2000
- Correo electrónico: 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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Contacto:
- John E. Yeakel
- Número de teléfono: 507-668-2063
- Correo electrónico: 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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Contacto:
- Jason T. Hayes
- Número de teléfono: 507-668-2063
- Correo electrónico: 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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Contacto:
- William Breen
- Número de teléfono: 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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Contacto:
- Now Bahar Alam
- Número de teléfono: 715-464-8124
- Correo electrónico: 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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Contacto:
- Abigail L. Stockham
- Número de teléfono: 608-392-7332
- Correo electrónico: stockham.abigail@mayo.edu
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Investigador principal:
- Abigail L. Stockham
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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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
Otros nombres:
Undergo MRI
Otros nombres:
Ancillary studies Undergo FET or FDOPA PET/CT
Otros nombres:
Given via injection
Otros nombres:
Given IV
Otros nombres:
Undergo dose-intensified photon radiation therapy
Otros nombres:
Undergo FET or FDOPA PET/CT
Otros nombres:
Undergo dose-intensified proton radiation therapy
Otros nombres:
Undergo standard proton radiation therapy
Otros nombres:
Undergo dose-intensified accelerated proton radiation therapy
Otros nombres:
Undergo accelerated proton radiation therapy
Otros nombres:
Given SOC temozolomide
Otros nombres:
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Comparador activo: 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
Otros nombres:
Undergo MRI
Otros nombres:
Ancillary studies Undergo FET or FDOPA PET/CT
Otros nombres:
Given via injection
Otros nombres:
Given IV
Otros nombres:
Undergo FET or FDOPA PET/CT
Otros nombres:
Undergo dose-intensified proton radiation therapy
Otros nombres:
Undergo standard proton radiation therapy
Otros nombres:
Undergo dose-intensified accelerated proton radiation therapy
Otros nombres:
Undergo accelerated proton radiation therapy
Otros nombres:
Given SOC temozolomide
Otros nombres:
Undergo standard photon radiation therapy
Otros nombres:
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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
Otros nombres:
Undergo FET or FDOPA PET/CT
Otros nombres:
Given via injection
Otros nombres:
Given IV
Otros nombres:
Undergo FET or FDOPA PET/CT
Otros nombres:
Undergo dose-intensified proton radiation therapy
Otros nombres:
Undergo standard proton radiation therapy
Otros nombres:
Undergo dose-intensified accelerated proton radiation therapy
Otros nombres:
Undergo accelerated proton radiation therapy
Otros nombres:
Given SOC temozolomide
Otros nombres:
Undergo dose-intensified accelerated photon radiation therapy
Otros nombres:
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Comparador activo: 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
Otros nombres:
Undergo FET or FDOPA PET/CT
Otros nombres:
Given via injection
Otros nombres:
Given IV
Otros nombres:
Undergo FET or FDOPA PET/CT
Otros nombres:
Undergo dose-intensified proton radiation therapy
Otros nombres:
Undergo standard proton radiation therapy
Otros nombres:
Undergo dose-intensified accelerated proton radiation therapy
Otros nombres:
Undergo accelerated proton radiation therapy
Otros nombres:
Given SOC temozolomide
Otros nombres:
Undergo accelerated photon radiation therapy
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall survival (Cohort 1)
Periodo de tiempo: Up to 18 months
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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
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Overall survival (Cohort 2)
Periodo de tiempo: Up to 12 months
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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
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of grade 3+ central nervous system (CNS) toxicity, regardless of attribution (Overall CNS toxicity)
Periodo de tiempo: Up to 36 months post-radiation therapy (RT)
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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)
Periodo de tiempo: Up to 36 months post-RT
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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
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Quality of life (Cohort 1) - EORTC QLQ-C30
Periodo de tiempo: Up to 6 months post-RT
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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
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Quality of life (Cohort 1) - EORTC QLQ-BN20
Periodo de tiempo: Up to 6 months post-RT
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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
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Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neurocognitive outcomes (Cohort 1)
Periodo de tiempo: Up to 1 month post-RT
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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
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: William Breen, Mayo Clinic in Rochester
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Astrocitoma
- Glioma
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Glioblastoma
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Técnicas de investigación
- Terapéutica
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Azoles
- Fenómeno físico
- Dacarbazina
- Triazenes
- Imidazoles
- Químicos inorgánicos
- Elementos
- Técnicas de química, analítica
- Análisis de espectro
- Iones
- Electrolitos
- Fenómenos electromagnéticos
- Fenómeno magnético
- Radioterapia
- Radiación electromagnética
- Gases
- Partículas elementales
- Luz
- Fenómeno óptico
- Radiación, nonionizante
- Radioterapia de iones pesados
- Cationes, monovalente
- Cationes
- Hidrógeno
- Nucleones
- Temozolomida
- Radiación
- Manejo de muestras
- Espectroscopía de resonancia magnética
- Fotones
- fluorodopa f 18
- Terapia de protones
- Protones
- (18F) fluoroetiltyrosina
Otros números de identificación del estudio
Otros números de identificación del estudio
- GMROR2661
- NCI-2026-07628 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 26-003443 (Otro identificador: Mayo Clinic Institutional Review Board)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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