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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
- Verfahren: Biospecimen Collection
- Verfahren: Magnetic Resonance Imaging
- Sonstiges: Questionnaire Administration
- Verfahren: Computed Tomography
- Strahlung: F-18 Fluoroethyltyrosine
- Arzneimittel: Fluorodopa F 18
- Strahlung: Dose-intensified Photon Beam Radiation Therapy
- Verfahren: Positron Emission Tomography
- Strahlung: Proton Beam Radiation Therapy
- Strahlung: Proton Beam Radiation Therapy
- Strahlung: Proton Beam Radiation Therapy
- Strahlung: Proton Beam Radiation Therapy
- Arzneimittel: Temozolomide
- Strahlung: Standard Photon Beam Radiation Therapy
- Strahlung: Dose-intensified Accelerated Photon Beam Radiation Therapy
- Strahlung: Accelerated Photon Beam Radiation Therapy
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 3
Kontakte und Standorte
Studienorte
-
-
Arizona
-
Scottsdale, Arizona, Vereinigte Staaten, 85259
- Mayo Clinic in Arizona
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Hauptermittler:
- Sujay A. Vora
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Kontakt:
- Sujay A. Vora
- Telefonnummer: 480-342-2000
- E-Mail: vora.sujay@mayo.edu
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32224-9980
- Mayo Clinic in Florida
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Hauptermittler:
- Daniel Trifiletti
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Kontakt:
- Daniel Trifiletti
- Telefonnummer: 904-953-2000
- E-Mail: trifiletti.daniel@mayo.edu
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Minnesota
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Albert Lea, Minnesota, Vereinigte Staaten, 56007
- Mayo Clinic Health System in Albert Lea
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Kontakt:
- John E. Yeakel
- Telefonnummer: 507-668-2063
- E-Mail: yeakel.john@mayo.edu
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Hauptermittler:
- John E. Yeakel
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Mankato, Minnesota, Vereinigte Staaten, 56001
- Mayo Clinic Health Systems-Mankato
-
Kontakt:
- Jason T. Hayes
- Telefonnummer: 507-668-2063
- E-Mail: hayes.jason@mayo.edu
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Hauptermittler:
- Jason T. Hayes
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic in Rochester
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Kontakt:
- William Breen
- Telefonnummer: 507-284-3261
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Hauptermittler:
- William Breen
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Wisconsin
-
Eau Claire, Wisconsin, Vereinigte Staaten, 54701
- Mayo Clinic Health System-Eau Claire Clinic
-
Kontakt:
- Now Bahar Alam
- Telefonnummer: 715-464-8124
- E-Mail: alam.nowbahar@mayo.edu
-
Hauptermittler:
- Now Bahar Alam
-
La Crosse, Wisconsin, Vereinigte Staaten, 54601
- Mayo Clinic Health System-Franciscan Healthcare
-
Kontakt:
- Abigail L. Stockham
- Telefonnummer: 608-392-7332
- E-Mail: stockham.abigail@mayo.edu
-
Hauptermittler:
- Abigail L. Stockham
-
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
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
Andere Namen:
Undergo MRI
Andere Namen:
Ancillary studies Undergo FET or FDOPA PET/CT
Andere Namen:
Given via injection
Andere Namen:
Given IV
Andere Namen:
Undergo dose-intensified photon radiation therapy
Andere Namen:
Undergo FET or FDOPA PET/CT
Andere Namen:
Undergo dose-intensified proton radiation therapy
Andere Namen:
Undergo standard proton radiation therapy
Andere Namen:
Undergo dose-intensified accelerated proton radiation therapy
Andere Namen:
Undergo accelerated proton radiation therapy
Andere Namen:
Given SOC temozolomide
Andere Namen:
|
|
Aktiver Komparator: 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
Andere Namen:
Undergo MRI
Andere Namen:
Ancillary studies Undergo FET or FDOPA PET/CT
Andere Namen:
Given via injection
Andere Namen:
Given IV
Andere Namen:
Undergo FET or FDOPA PET/CT
Andere Namen:
Undergo dose-intensified proton radiation therapy
Andere Namen:
Undergo standard proton radiation therapy
Andere Namen:
Undergo dose-intensified accelerated proton radiation therapy
Andere Namen:
Undergo accelerated proton radiation therapy
Andere Namen:
Given SOC temozolomide
Andere Namen:
Undergo standard photon radiation therapy
Andere Namen:
|
|
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
Andere Namen:
Undergo FET or FDOPA PET/CT
Andere Namen:
Given via injection
Andere Namen:
Given IV
Andere Namen:
Undergo FET or FDOPA PET/CT
Andere Namen:
Undergo dose-intensified proton radiation therapy
Andere Namen:
Undergo standard proton radiation therapy
Andere Namen:
Undergo dose-intensified accelerated proton radiation therapy
Andere Namen:
Undergo accelerated proton radiation therapy
Andere Namen:
Given SOC temozolomide
Andere Namen:
Undergo dose-intensified accelerated photon radiation therapy
Andere Namen:
|
|
Aktiver Komparator: 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
Andere Namen:
Undergo FET or FDOPA PET/CT
Andere Namen:
Given via injection
Andere Namen:
Given IV
Andere Namen:
Undergo FET or FDOPA PET/CT
Andere Namen:
Undergo dose-intensified proton radiation therapy
Andere Namen:
Undergo standard proton radiation therapy
Andere Namen:
Undergo dose-intensified accelerated proton radiation therapy
Andere Namen:
Undergo accelerated proton radiation therapy
Andere Namen:
Given SOC temozolomide
Andere Namen:
Undergo accelerated photon radiation therapy
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Overall survival (Cohort 1)
Zeitfenster: 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)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of grade 3+ central nervous system (CNS) toxicity, regardless of attribution (Overall CNS toxicity)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Neurocognitive outcomes (Cohort 1)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: William Breen, Mayo Clinic in Rochester
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen
- Neubildungen nach histologischem Typ
- Neubildungen, Drüsen und Epithelien
- Astrozytom
- Gliom
- Neubildungen, Neuroepithel
- Neuroektodermale Tumoren
- Neoplasmen, Keimzelle und Embryonal
- Neubildungen, Nervengewebe
- Glioblastom
- Organische Chemikalien
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Untersuchungstechniken
- Therapeutika
- Klinische Labortechniken
- Diagnosetechniken und Verfahren
- Diagnose
- Azolen
- Physikalische Phänomene
- Dacarbazin
- Triazenes
- Imidazoles
- Anorganische Chemikalien
- Elemente
- Chemie -Techniken, analytisch
- Spektrumanalyse
- Ionen
- Elektrolyte
- Elektromagnetische Phänomene
- Magnetische Phänomene
- Strahlentherapie
- Elektromagnetische Strahlung
- Gase
- Elementarpartikel
- Licht
- Optische Phänomene
- Strahlung, nichtionisierend
- Schwere Ionenstrahlentherapie
- Kationen, monovalent
- Kationen
- Wasserstoff
- Nukleone
- Temozolomid
- Strahlung
- Handhabung von Proben
- Magnetresonanzspektroskopie
- Photonen
- Fluorodopa f 18
- Protonentherapie
- Protonen
- (18f) Fluoroethyltyrosin
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- GMROR2661
- NCI-2026-07628 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- 26-003443 (Andere Kennung: Mayo Clinic Institutional Review Board)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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