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
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
- Fremgangsmåte: Biospecimen Collection
- Fremgangsmåte: Magnetic Resonance Imaging
- Annen: Questionnaire Administration
- Fremgangsmåte: Computed Tomography
- Stråling: F-18 Fluoroethyltyrosine
- Legemiddel: Fluorodopa F 18
- Stråling: Dose-intensified Photon Beam Radiation Therapy
- Fremgangsmåte: Positron Emission Tomography
- Stråling: Proton Beam Radiation Therapy
- Stråling: Proton Beam Radiation Therapy
- Stråling: Proton Beam Radiation Therapy
- Stråling: Proton Beam Radiation Therapy
- Legemiddel: Temozolomide
- Stråling: Standard Photon Beam Radiation Therapy
- Stråling: Dose-intensified Accelerated Photon Beam Radiation Therapy
- Stråling: Accelerated Photon Beam Radiation Therapy
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Arizona
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Scottsdale, Arizona, Forente stater, 85259
- Mayo Clinic in Arizona
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Hovedetterforsker:
- Sujay A. Vora
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Ta kontakt med:
- Sujay A. Vora
- Telefonnummer: 480-342-2000
- E-post: vora.sujay@mayo.edu
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Florida
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Jacksonville, Florida, Forente stater, 32224-9980
- Mayo Clinic in Florida
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Hovedetterforsker:
- Daniel Trifiletti
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Ta kontakt med:
- Daniel Trifiletti
- Telefonnummer: 904-953-2000
- E-post: trifiletti.daniel@mayo.edu
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Minnesota
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Albert Lea, Minnesota, Forente stater, 56007
- Mayo Clinic Health System in Albert Lea
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Ta kontakt med:
- John E. Yeakel
- Telefonnummer: 507-668-2063
- E-post: yeakel.john@mayo.edu
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Hovedetterforsker:
- John E. Yeakel
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Mankato, Minnesota, Forente stater, 56001
- Mayo Clinic Health Systems-Mankato
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Ta kontakt med:
- Jason T. Hayes
- Telefonnummer: 507-668-2063
- E-post: hayes.jason@mayo.edu
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Hovedetterforsker:
- Jason T. Hayes
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic in Rochester
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Ta kontakt med:
- William Breen
- Telefonnummer: 507-284-3261
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Hovedetterforsker:
- William Breen
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Wisconsin
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Eau Claire, Wisconsin, Forente stater, 54701
- Mayo Clinic Health System-Eau Claire Clinic
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Ta kontakt med:
- Now Bahar Alam
- Telefonnummer: 715-464-8124
- E-post: alam.nowbahar@mayo.edu
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Hovedetterforsker:
- Now Bahar Alam
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La Crosse, Wisconsin, Forente stater, 54601
- Mayo Clinic Health System-Franciscan Healthcare
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Ta kontakt med:
- Abigail L. Stockham
- Telefonnummer: 608-392-7332
- E-post: stockham.abigail@mayo.edu
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Hovedetterforsker:
- Abigail L. Stockham
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
Andre navn:
Undergo MRI
Andre navn:
Ancillary studies Undergo FET or FDOPA PET/CT
Andre navn:
Given via injection
Andre navn:
Given IV
Andre navn:
Undergo dose-intensified photon radiation therapy
Andre navn:
Undergo FET or FDOPA PET/CT
Andre navn:
Undergo dose-intensified proton radiation therapy
Andre navn:
Undergo standard proton radiation therapy
Andre navn:
Undergo dose-intensified accelerated proton radiation therapy
Andre navn:
Undergo accelerated proton radiation therapy
Andre navn:
Given SOC temozolomide
Andre navn:
|
|
Aktiv 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
Andre navn:
Undergo MRI
Andre navn:
Ancillary studies Undergo FET or FDOPA PET/CT
Andre navn:
Given via injection
Andre navn:
Given IV
Andre navn:
Undergo FET or FDOPA PET/CT
Andre navn:
Undergo dose-intensified proton radiation therapy
Andre navn:
Undergo standard proton radiation therapy
Andre navn:
Undergo dose-intensified accelerated proton radiation therapy
Andre navn:
Undergo accelerated proton radiation therapy
Andre navn:
Given SOC temozolomide
Andre navn:
Undergo standard photon radiation therapy
Andre navn:
|
|
Eksperimentell: 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
Andre navn:
Undergo FET or FDOPA PET/CT
Andre navn:
Given via injection
Andre navn:
Given IV
Andre navn:
Undergo FET or FDOPA PET/CT
Andre navn:
Undergo dose-intensified proton radiation therapy
Andre navn:
Undergo standard proton radiation therapy
Andre navn:
Undergo dose-intensified accelerated proton radiation therapy
Andre navn:
Undergo accelerated proton radiation therapy
Andre navn:
Given SOC temozolomide
Andre navn:
Undergo dose-intensified accelerated photon radiation therapy
Andre navn:
|
|
Aktiv 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
Andre navn:
Undergo FET or FDOPA PET/CT
Andre navn:
Given via injection
Andre navn:
Given IV
Andre navn:
Undergo FET or FDOPA PET/CT
Andre navn:
Undergo dose-intensified proton radiation therapy
Andre navn:
Undergo standard proton radiation therapy
Andre navn:
Undergo dose-intensified accelerated proton radiation therapy
Andre navn:
Undergo accelerated proton radiation therapy
Andre navn:
Given SOC temozolomide
Andre navn:
Undergo accelerated photon radiation therapy
Andre navn:
|
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival (Cohort 1)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of grade 3+ central nervous system (CNS) toxicity, regardless of attribution (Overall CNS toxicity)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neurocognitive outcomes (Cohort 1)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Etterforskere
Etterforskere
- Hovedetterforsker: William Breen, Mayo Clinic in Rochester
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Astrocytom
- Glioma
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Glioblastom
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Undersøkelsesteknikker
- Terapeutikk
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Azoler
- Fysiske fenomener
- Dacarbazine
- Triazener
- Imidazoles
- Uorganiske kjemikalier
- Elementer
- Kjemisteknikker, analytisk
- Spektrumanalyse
- Ioner
- Elektrolytter
- Elektromagnetiske fenomener
- Magnetiske fenomener
- Strålebehandling
- Elektromagnetisk stråling
- Gasser
- Elementære partikler
- Lys
- Optiske fenomener
- Stråling, ikke -ionisering
- Tung ionstrålebehandling
- Kationer, monovalent
- Kationer
- Hydrogen
- Nukleoner
- Temozolomid
- Stråling
- Prøvehåndtering
- Magnetisk resonansspektroskopi
- Fotoner
- Fluorodopa F 18
- Protonterapi
- Protoner
- (18F) Fluoroetyltyrosin
Andre studie-ID-numre
Andre studie-ID-numre
- GMROR2661
- NCI-2026-07628 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- 26-003443 (Annen identifikator: Mayo Clinic Institutional Review Board)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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