Advanced Imaging-Guided Standard Versus Dose-Intensified Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma, SAGA 2.0 Trial
Key facts
- Who runs it
- Mayo Clinic
- Where
- Albert Lea, Eau Claire, Jacksonville, La Crosse, Mankato, Rochester, and Scottsdale, United StatesSee the 7 sites
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 292 people, planned
- Started
- 10 Nov 2026
- Expected to end
- 2 Nov 2035
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Biospecimen Collection
- Computed Tomography
- F-18 Fluoroethyltyrosine
- Fluorodopa F 18
- Magnetic Resonance Imaging
- Dose-intensified Photon Beam Radiation Therapy
- Standard Photon Beam Radiation Therapy
- Dose-intensified Accelerated Photon Beam Radiation Therapy
- Accelerated Photon Beam Radiation Therapy
- Positron Emission Tomography
- Proton Beam Radiation Therapy
- Questionnaire Administration
- Temozolomide
- Record updated
- 13 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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)
- 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)
Where in United States
- Mayo Clinic Health System in Albert LeaAlbert Lea, United StatesContact: John E. YeakelNo longer taking part
- Mayo Clinic Health System-Eau Claire ClinicEau Claire, United StatesContact: Now Bahar AlamNo longer taking part
- Mayo Clinic in FloridaJacksonville, United StatesContact: Daniel TrifilettiNo longer taking part
- Mayo Clinic Health System-Franciscan HealthcareLa Crosse, United StatesContact: Abigail L. StockhamNo longer taking part
- Mayo Clinic Health Systems-MankatoMankato, United StatesContact: Jason T. HayesNo longer taking part
- Mayo Clinic in RochesterRochester, United StatesContact: William BreenNo longer taking part
- Mayo Clinic in ArizonaScottsdale, United StatesContact: Sujay A. VoraNo longer taking part
About the trial
What the trial wants to find out
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.
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IND Numbers: 61300, 140882, 176402, 154793, 167879
The 4 groups in the trial
- Arm A (dose-intensified radiation therapy)Treatment being tested
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.
Treatment: Biospecimen Collection, Computed Tomography, F-18 Fluoroethyltyrosine, Fluorodopa F 18, Magnetic Resonance Imaging, Dose-intensified Photon Beam Radiation Therapy, Positron Emission Tomography, Proton Beam Radiation Therapy, Questionnaire Administration, and Temozolomide
- Arm B (standard radiation therapy)Existing treatment, for comparison
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.
Treatment: Biospecimen Collection, Computed Tomography, F-18 Fluoroethyltyrosine, Fluorodopa F 18, Magnetic Resonance Imaging, Standard Photon Beam Radiation Therapy, Positron Emission Tomography, Proton Beam Radiation Therapy, Questionnaire Administration, and Temozolomide
- Arm C (dose-intensified accelerated radiation therapy)Treatment being tested
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.
Treatment: Computed Tomography, F-18 Fluoroethyltyrosine, Fluorodopa F 18, Magnetic Resonance Imaging, Dose-intensified Accelerated Photon Beam Radiation Therapy, Positron Emission Tomography, Proton Beam Radiation Therapy, and Temozolomide
- Arm D (accelerated radiation therapy)Existing treatment, for comparison
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.
Treatment: Computed Tomography, F-18 Fluoroethyltyrosine, Fluorodopa F 18, Magnetic Resonance Imaging, Accelerated Photon Beam Radiation Therapy, Positron Emission Tomography, Proton Beam Radiation Therapy, and Temozolomide
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Stereotactic Advanced-Imaging Guided Radiotherapy for Glioblastoma (SAGA 2.0)
- Record updated
- 13 November 2026