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
Studieöversikt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
- Procedur: Biospecimen Collection
- Procedur: Magnetic Resonance Imaging
- Övrig: Questionnaire Administration
- Procedur: Computed Tomography
- Strålning: F-18 Fluoroethyltyrosine
- Läkemedel: Fluorodopa F 18
- Strålning: Dose-intensified Photon Beam Radiation Therapy
- Procedur: Positron Emission Tomography
- Strålning: Proton Beam Radiation Therapy
- Strålning: Proton Beam Radiation Therapy
- Strålning: Proton Beam Radiation Therapy
- Strålning: Proton Beam Radiation Therapy
- Läkemedel: Temozolomide
- Strålning: Standard Photon Beam Radiation Therapy
- Strålning: Dose-intensified Accelerated Photon Beam Radiation Therapy
- Strålning: Accelerated Photon Beam Radiation Therapy
Studietyp
Studietyp
Inskrivning (Beräknad)
Inskrivning
Fas
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Arizona
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Scottsdale, Arizona, Förenta staterna, 85259
- Mayo Clinic in Arizona
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Huvudutredare:
- Sujay A. Vora
-
Kontakt:
- Sujay A. Vora
- Telefonnummer: 480-342-2000
- E-post: vora.sujay@mayo.edu
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-
Florida
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Jacksonville, Florida, Förenta staterna, 32224-9980
- Mayo Clinic in Florida
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Huvudutredare:
- Daniel Trifiletti
-
Kontakt:
- Daniel Trifiletti
- Telefonnummer: 904-953-2000
- E-post: trifiletti.daniel@mayo.edu
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-
Minnesota
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Albert Lea, Minnesota, Förenta staterna, 56007
- Mayo Clinic Health System in Albert Lea
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Kontakt:
- John E. Yeakel
- Telefonnummer: 507-668-2063
- E-post: yeakel.john@mayo.edu
-
Huvudutredare:
- John E. Yeakel
-
Mankato, Minnesota, Förenta staterna, 56001
- Mayo Clinic Health Systems-Mankato
-
Kontakt:
- Jason T. Hayes
- Telefonnummer: 507-668-2063
- E-post: hayes.jason@mayo.edu
-
Huvudutredare:
- Jason T. Hayes
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
-
Kontakt:
- William Breen
- Telefonnummer: 507-284-3261
-
Huvudutredare:
- William Breen
-
-
Wisconsin
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Eau Claire, Wisconsin, Förenta staterna, 54701
- Mayo Clinic Health System-Eau Claire Clinic
-
Kontakt:
- Now Bahar Alam
- Telefonnummer: 715-464-8124
- E-post: alam.nowbahar@mayo.edu
-
Huvudutredare:
- Now Bahar Alam
-
La Crosse, Wisconsin, Förenta staterna, 54601
- Mayo Clinic Health System-Franciscan Healthcare
-
Kontakt:
- Abigail L. Stockham
- Telefonnummer: 608-392-7332
- E-post: stockham.abigail@mayo.edu
-
Huvudutredare:
- Abigail L. Stockham
-
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Deltagandekriterier
Urvalskriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Antal vapen
Vapen och interventioner
Deltagargrupp / ArmDeltagargrupp / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
Undergo MRI
Andra namn:
Ancillary studies Undergo FET or FDOPA PET/CT
Andra namn:
Given via injection
Andra namn:
Given IV
Andra namn:
Undergo dose-intensified photon radiation therapy
Andra namn:
Undergo FET or FDOPA PET/CT
Andra namn:
Undergo dose-intensified proton radiation therapy
Andra namn:
Undergo standard proton radiation therapy
Andra namn:
Undergo dose-intensified accelerated proton radiation therapy
Andra namn:
Undergo accelerated proton radiation therapy
Andra namn:
Given SOC temozolomide
Andra namn:
|
|
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
Andra namn:
Undergo MRI
Andra namn:
Ancillary studies Undergo FET or FDOPA PET/CT
Andra namn:
Given via injection
Andra namn:
Given IV
Andra namn:
Undergo FET or FDOPA PET/CT
Andra namn:
Undergo dose-intensified proton radiation therapy
Andra namn:
Undergo standard proton radiation therapy
Andra namn:
Undergo dose-intensified accelerated proton radiation therapy
Andra namn:
Undergo accelerated proton radiation therapy
Andra namn:
Given SOC temozolomide
Andra namn:
Undergo standard photon radiation therapy
Andra namn:
|
|
Experimentell: 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
Andra namn:
Undergo FET or FDOPA PET/CT
Andra namn:
Given via injection
Andra namn:
Given IV
Andra namn:
Undergo FET or FDOPA PET/CT
Andra namn:
Undergo dose-intensified proton radiation therapy
Andra namn:
Undergo standard proton radiation therapy
Andra namn:
Undergo dose-intensified accelerated proton radiation therapy
Andra namn:
Undergo accelerated proton radiation therapy
Andra namn:
Given SOC temozolomide
Andra namn:
Undergo dose-intensified accelerated photon radiation therapy
Andra namn:
|
|
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
Andra namn:
Undergo FET or FDOPA PET/CT
Andra namn:
Given via injection
Andra namn:
Given IV
Andra namn:
Undergo FET or FDOPA PET/CT
Andra namn:
Undergo dose-intensified proton radiation therapy
Andra namn:
Undergo standard proton radiation therapy
Andra namn:
Undergo dose-intensified accelerated proton radiation therapy
Andra namn:
Undergo accelerated proton radiation therapy
Andra namn:
Given SOC temozolomide
Andra namn:
Undergo accelerated photon radiation therapy
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall survival (Cohort 1)
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of grade 3+ central nervous system (CNS) toxicity, regardless of attribution (Overall CNS toxicity)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neurocognitive outcomes (Cohort 1)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Sponsor
Utredare
Utredare
- Huvudutredare: William Breen, Mayo Clinic in Rochester
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Studiestart
Primärt slutförande (Beräknad)
Primärt slutförande
Avslutad studie (Beräknad)
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Första postat
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste uppdatering publicerad
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer
- Neoplasmer efter histologisk typ
- Neoplasmer, körtel och epitel
- Astrocytom
- Gliom
- Neoplasmer, neuroepitelial
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Glioblastom
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Undersökningstekniker
- Terapeutik
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Azoler
- Fysiska fenomen
- Dacarbazin
- Triazenes
- Imidazoler
- Oorganiska kemikalier
- Element
- Kemitekniker, analytiska
- Spektrumanalys
- Joner
- Elektrolyter
- Elektromagnetiska fenomen
- Magnetfenomen
- Strålbehandling
- Elektromagnetisk strålning
- Gaser
- Elementära partiklar
- Ljus
- Optiska fenomen
- Strålning, nonjoniserande
- Tunga jon strålbehandling
- Katjoner, monovalent
- Katjor
- Väte
- Kärnor
- Temozolomid
- Strålning
- Provhantering
- Magnetresonansspektroskopi
- Fotoner
- fluorodopa f 18
- Protonbehandling
- Protoner
- (18f) fluoroetyltyrosin
Andra studie-ID-nummer
Andra studie-ID-nummer
- GMROR2661
- NCI-2026-07628 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- 26-003443 (Annan identifierare: Mayo Clinic Institutional Review Board)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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