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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
- Procedura: Biospecimen Collection
- Procedura: Magnetic Resonance Imaging
- Altro: Questionnaire Administration
- Procedura: Computed Tomography
- Radiazione: F-18 Fluoroethyltyrosine
- Droga: Fluorodopa F 18
- Radiazione: Dose-intensified Photon Beam Radiation Therapy
- Procedura: Positron Emission Tomography
- Radiazione: Proton Beam Radiation Therapy
- Radiazione: Proton Beam Radiation Therapy
- Radiazione: Proton Beam Radiation Therapy
- Radiazione: Proton Beam Radiation Therapy
- Droga: Temozolomide
- Radiazione: Standard Photon Beam Radiation Therapy
- Radiazione: Dose-intensified Accelerated Photon Beam Radiation Therapy
- Radiazione: Accelerated Photon Beam Radiation Therapy
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85259
- Mayo Clinic in Arizona
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Investigatore principale:
- Sujay A. Vora
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Contatto:
- Sujay A. Vora
- Numero di telefono: 480-342-2000
- Email: vora.sujay@mayo.edu
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Florida
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Jacksonville, Florida, Stati Uniti, 32224-9980
- Mayo Clinic in Florida
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Investigatore principale:
- Daniel Trifiletti
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Contatto:
- Daniel Trifiletti
- Numero di telefono: 904-953-2000
- Email: trifiletti.daniel@mayo.edu
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Minnesota
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Albert Lea, Minnesota, Stati Uniti, 56007
- Mayo Clinic Health System in Albert Lea
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Contatto:
- John E. Yeakel
- Numero di telefono: 507-668-2063
- Email: yeakel.john@mayo.edu
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Investigatore principale:
- John E. Yeakel
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Mankato, Minnesota, Stati Uniti, 56001
- Mayo Clinic Health Systems-Mankato
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Contatto:
- Jason T. Hayes
- Numero di telefono: 507-668-2063
- Email: hayes.jason@mayo.edu
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Investigatore principale:
- Jason T. Hayes
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic in Rochester
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Contatto:
- William Breen
- Numero di telefono: 507-284-3261
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Investigatore principale:
- William Breen
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Wisconsin
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Eau Claire, Wisconsin, Stati Uniti, 54701
- Mayo Clinic Health System-Eau Claire Clinic
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Contatto:
- Now Bahar Alam
- Numero di telefono: 715-464-8124
- Email: alam.nowbahar@mayo.edu
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Investigatore principale:
- Now Bahar Alam
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La Crosse, Wisconsin, Stati Uniti, 54601
- Mayo Clinic Health System-Franciscan Healthcare
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Contatto:
- Abigail L. Stockham
- Numero di telefono: 608-392-7332
- Email: stockham.abigail@mayo.edu
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Investigatore principale:
- Abigail L. Stockham
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
Undergo MRI
Altri nomi:
Ancillary studies Undergo FET or FDOPA PET/CT
Altri nomi:
Given via injection
Altri nomi:
Given IV
Altri nomi:
Undergo dose-intensified photon radiation therapy
Altri nomi:
Undergo FET or FDOPA PET/CT
Altri nomi:
Undergo dose-intensified proton radiation therapy
Altri nomi:
Undergo standard proton radiation therapy
Altri nomi:
Undergo dose-intensified accelerated proton radiation therapy
Altri nomi:
Undergo accelerated proton radiation therapy
Altri nomi:
Given SOC temozolomide
Altri nomi:
|
|
Comparatore attivo: 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
Altri nomi:
Undergo MRI
Altri nomi:
Ancillary studies Undergo FET or FDOPA PET/CT
Altri nomi:
Given via injection
Altri nomi:
Given IV
Altri nomi:
Undergo FET or FDOPA PET/CT
Altri nomi:
Undergo dose-intensified proton radiation therapy
Altri nomi:
Undergo standard proton radiation therapy
Altri nomi:
Undergo dose-intensified accelerated proton radiation therapy
Altri nomi:
Undergo accelerated proton radiation therapy
Altri nomi:
Given SOC temozolomide
Altri nomi:
Undergo standard photon radiation therapy
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Undergo FET or FDOPA PET/CT
Altri nomi:
Given via injection
Altri nomi:
Given IV
Altri nomi:
Undergo FET or FDOPA PET/CT
Altri nomi:
Undergo dose-intensified proton radiation therapy
Altri nomi:
Undergo standard proton radiation therapy
Altri nomi:
Undergo dose-intensified accelerated proton radiation therapy
Altri nomi:
Undergo accelerated proton radiation therapy
Altri nomi:
Given SOC temozolomide
Altri nomi:
Undergo dose-intensified accelerated photon radiation therapy
Altri nomi:
|
|
Comparatore attivo: 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
Altri nomi:
Undergo FET or FDOPA PET/CT
Altri nomi:
Given via injection
Altri nomi:
Given IV
Altri nomi:
Undergo FET or FDOPA PET/CT
Altri nomi:
Undergo dose-intensified proton radiation therapy
Altri nomi:
Undergo standard proton radiation therapy
Altri nomi:
Undergo dose-intensified accelerated proton radiation therapy
Altri nomi:
Undergo accelerated proton radiation therapy
Altri nomi:
Given SOC temozolomide
Altri nomi:
Undergo accelerated photon radiation therapy
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall survival (Cohort 1)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of grade 3+ central nervous system (CNS) toxicity, regardless of attribution (Overall CNS toxicity)
Lasso di tempo: 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)
|
|
Incidence of grade 3+ higher CNS toxicity at least possibly attributable to radiation therapy (Treatment-related CNS toxicity)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Neurocognitive outcomes (Cohort 1)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: William Breen, Mayo Clinic in Rochester
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie
- Neoplasie per tipo istologico
- Neoplasie, ghiandolari ed epiteliali
- Astrocitoma
- Glioma
- Neoplasie, Neuroepiteliali
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Glioblastoma
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Tecniche investigative
- Terapie
- Tecniche di laboratorio clinico
- Tecniche e procedure diagnostiche
- Diagnosi
- Azoli
- Fenomeni fisici
- Dacarbazine
- Triazenes
- Imidazoli
- Prodotti chimici inorganici
- Elementi
- Tecniche di chimica, analitiche
- Analisi dello spettro
- Ioni
- Elettroliti
- Fenomeni elettromagnetici
- Fenomeni magnetici
- Radioterapia
- Radiazioni elettromagnetiche
- Gas
- Particelle elementari
- Leggero
- Fenomeni ottici
- Radiazione, non ionizzante
- Radioterapia ionica pesante
- Cationi, monovalenti
- Cationi
- Idrogeno
- Nucleoni
- Temozolomide
- Radiazione
- Gestione dei campioni
- Spettroscopia di risonanza magnetica
- Fotoni
- Fluorodopa F 18
- Terapia protonica
- Protoni
- (18f) fluoroetiltirosina
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- GMROR2661
- NCI-2026-07628 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- 26-003443 (Altro identificatore: Mayo Clinic Institutional Review Board)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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