ClinicalTrials.gg
Not yet recruitingNCT07935889Updated Nov 13, 2026

Advanced Imaging-Guided Standard Versus Dose-Intensified Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma, SAGA 2.0 Trial

A Phase 3 interventional study of Biospecimen Collection and Computed Tomography in Glioblastoma, IDH-Wildtype, sponsored by Mayo Clinic. Not yet recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Phase 3
Study type
Interventional
Enrollment
292
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 23 studies in Glioblastoma by Mayo Clinic — 12 open to participants now, 16 under way, 1 of them phase 3. Glioblastoma · Mayo Clinic.

Planned enrollment
Largest of 23
292 · median 36
Started
2026
with 4 others
Phase 3
Only one
of the 23
Primary completion
2035-11
later than 14 of 15 live
Registered
23rd of 23
by date

Among the 23 studies in Glioblastoma by Mayo Clinic, this one has the largest planned enrollment, is one of 5 that started in 2026, is the only one in phase 3, reaches primary completion later than 14 of the 15 other live ones, and was the 23rd registered.

Glioblastoma

2,135 studies on the registry are indexed under Glioblastoma; 466 are open to participants now.

Browse Glioblastoma studies →

Open to participants now

12 of the 23 studies in Glioblastoma by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:

6 more — sign in →

By country, each count listing its studies:

All 12 open studies →

Where they have run

Who these studies take

Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 23 studies in Glioblastoma by Mayo Clinic, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Glioblastoma, IDH-Wildtype

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Histological confirmation of glioblastoma (IDH-wildtype)
  • (ECOG) Performance Status (PS) ≤ 3 at baseline
  • Provide written 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

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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
292 participants (estimated)

Study arms

  • 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.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography · Radiation: F-18 Fluoroethyltyrosine · Drug: Fluorodopa F 18 · Procedure: Magnetic Resonance Imaging · Radiation: Dose-intensified Photon Beam Radiation Therapy · Procedure: Positron Emission Tomography · Radiation: Proton Beam Radiation Therapy · Other: Questionnaire Administration · Drug: Temozolomide

  • Active comparator
    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.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography · Radiation: F-18 Fluoroethyltyrosine · Drug: Fluorodopa F 18 · Procedure: Magnetic Resonance Imaging · Radiation: Standard Photon Beam Radiation Therapy · Procedure: Positron Emission Tomography · Radiation: Proton Beam Radiation Therapy · Other: Questionnaire Administration · Drug: Temozolomide

  • 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.

    Procedure: Computed Tomography · Radiation: F-18 Fluoroethyltyrosine · Drug: Fluorodopa F 18 · Procedure: Magnetic Resonance Imaging · Radiation: Dose-intensified Accelerated Photon Beam Radiation Therapy · Procedure: Positron Emission Tomography · Radiation: Proton Beam Radiation Therapy · Drug: Temozolomide

  • Active comparator
    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.

    Procedure: Computed Tomography · Radiation: F-18 Fluoroethyltyrosine · Drug: Fluorodopa F 18 · Procedure: Magnetic Resonance Imaging · Radiation: Accelerated Photon Beam Radiation Therapy · Procedure: Positron Emission Tomography · Radiation: Proton Beam Radiation Therapy · Drug: Temozolomide

Interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureComputed Tomography

    Undergo FET or FDOPA PET/CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • RadiationF-18 Fluoroethyltyrosine

    Given via injection

    Also known as: 18F-FET, 18FET, 2'-[F18] Fluoro-ethyl-L-tyrosine, [18F]-Fluoro-ethyl-L-tyrosine, FLORETYROSINE F-18, Fluorine-18 2'-Fluoroethyl-L-tyrosine, Fluoroethyltyrosine F18, O-(2[F18]fluoroethyl)-L-tyrosine

  • Given IV

    Also known as: (18F)FDOPA, 18F-DOPA, 18F-FDOPA, 3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine, 6-(18F)Fluoro-L-DOPA, Fluorine F 18 Fluorodopa, Fluorine-18-fluoro-L-DOPA, Fluorodopa (18F), FLUORODOPA F-18, L-6-(18F)Fluoro-DOPA

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

  • RadiationDose-intensified Photon Beam Radiation Therapy

    Undergo dose-intensified photon radiation therapy

    Also known as: External beam radiation therapy using photons (procedure), Photon, photon beam radiation therapy, Photon EBRT, Photon External Beam Radiotherapy, PHOTON Therapy, Radiation, Photon Beam

  • RadiationStandard Photon Beam Radiation Therapy

    Undergo standard photon radiation therapy

    Also known as: External beam radiation therapy using photons (procedure), Photon, photon beam radiation therapy, Photon EBRT, Photon External Beam Radiotherapy, PHOTON Therapy, Radiation, Photon Beam

  • RadiationDose-intensified Accelerated Photon Beam Radiation Therapy

    Undergo dose-intensified accelerated photon radiation therapy

    Also known as: External beam radiation therapy using photons (procedure), Photon, photon beam radiation therapy, Photon EBRT, Photon External Beam Radiotherapy, PHOTON Therapy, Radiation, Photon Beam

  • RadiationAccelerated Photon Beam Radiation Therapy

    Undergo accelerated photon radiation therapy

    Also known as: External beam radiation therapy using photons (procedure), Photon, photon beam radiation therapy, Photon EBRT, Photon External Beam Radiotherapy, PHOTON Therapy, Radiation, Photon Beam

  • ProcedurePositron Emission Tomography

    Undergo FET or FDOPA PET/CT

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

  • RadiationProton Beam Radiation Therapy

    Undergo dose-intensified proton radiation therapy

    Also known as: External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy, Proton Radiation Therapy, PROTON Therapy, Radiation, Proton Beam

  • RadiationProton Beam Radiation Therapy

    Undergo standard proton radiation therapy

    Also known as: External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy, Proton Radiation Therapy, PROTON Therapy, Radiation, Proton Beam

  • RadiationProton Beam Radiation Therapy

    Undergo dose-intensified accelerated proton radiation therapy

    Also known as: External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy, Proton Radiation Therapy, PROTON Therapy, Radiation, Proton Beam

  • RadiationProton Beam Radiation Therapy

    Undergo accelerated proton radiation therapy

    Also known as: External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy, Proton Radiation Therapy, PROTON Therapy, Radiation, Proton Beam

  • OtherQuestionnaire Administration

    Ancillary studies

  • Given SOC temozolomide

    Also known as: CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temizole, Temodal, Temodar, Temomedac, TMZ

06

What researchers measure

Primary outcomes

  1. Overall survival (Cohort 1)

    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.

    Time frame: Up to 18 months

  2. Overall survival (Cohort 2)

    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.

    Time frame: Up to 12 months

Secondary outcomes

  1. Incidence of grade 3+ central nervous system (CNS) toxicity, regardless of attribution (Overall CNS toxicity)

    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.

    Time frame: Up to 36 months post-radiation therapy (RT)

  2. Incidence of grade 3+ higher CNS toxicity at least possibly attributable to radiation therapy (Treatment-related CNS toxicity)

    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.

    Time frame: Up to 36 months post-RT

  3. Quality of life (Cohort 1) - EORTC QLQ-C30

    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.

    Time frame: Up to 6 months post-RT

  4. Quality of life (Cohort 1) - EORTC QLQ-BN20

    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.

    Time frame: Up to 6 months post-RT

Other outcomes

  1. Neurocognitive outcomes (Cohort 1)

    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.

    Time frame: Up to 1 month post-RT

07

Study locations

7 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2035, 107 months later.

Of 43 phase 3 interventional studies under Glioblastoma, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 87. This study's planned 107 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2026
First posted
Nov 13, 2026
StartEst.
Nov 10, 2026
Primary completionEst.
Nov 2, 2035
CompletionEst.
Nov 2, 2035
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07935889
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Nov 2, 2035 (estimated)
Completion
Nov 2, 2035 (estimated)
Last update
Nov 13, 2026

Study contacts

William Breen
principal investigator · Mayo Clinic in Rochester

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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