Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study
NCT ID: NCT05781321
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
170 participants
INTERVENTIONAL
2023-03-23
2028-07-02
Brief Summary
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Detailed Description
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I. To demonstrate non-inferior 12-month overall survival (OS) of patients with GBM treated with dose escalated hypofractionated radiotherapy compared to standard of care.
SECONDARY OBJECTIVES:
I. To demonstrate the safety of short-course radiotherapy via physician-reported grade (G) 3+ toxicity.
II. To explore patient-reported outcomes to demonstrate favorable quality of life with short-course radiotherapy for GBM.
III. To analyze the impact of shortening the treatment duration on treatment related lymphopenia and absolute lymphocyte counts.
EXPLORATORY OBJECTIVES:
I. To determine the cost-effectiveness of the 5-fraction treatment regimen compared to standard of care.
II. To explore the impact on the immune system with the 5-fraction treatment regimen. Immune phenotyping will be assessed by Flow Cytometry and cytometry by flight (CyTOF).
III. To analyze series of cytokine levels over time. IV. To assess patterns of failure, specifically focusing on differences in volume delineation via Fluorodopa F 18 (FDOPA) and magnetic resonance imaging (MRI) and recurrences in-field versus (vs.) out of field.
V. To conduct a subgroup analysis for just patients =\< 65 cc. VI. To conduct a subgroup analysis for just patients with and without tumor treating fields.
VII. To analyze patient demographic data compared to historical controls to determine whether the short-course treatment regimen improves access to underserved populations.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo short course RT for 5-10 fractions over 1-2 weeks on study. Patients also receive temozolomide orally (PO) on days 1-5 every 28 days during radiation therapy. Starting one month post-radiation, patients continue temozolomide on days 1-5 every 28 days for up to 5 adjuvant cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients undergo standard course RT for 15-30 fractions over 3-6 weeks on study. Patients also receive temozolomide PO daily (QD) concurrently with radiation therapy and for up to 6 adjuvant cycles in the absence of disease progression or unacceptable toxicity.
All patients undergo positron emission tomography/computed tomography (PET/CT) with 18-F-DOPA administered intravenously (IV) prior to RT on study, and undergo MRI prior to RT and throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
After completion of study treatment, patients are followed up every 2 months for the first year, every 3 months for the second year, and every 4 months for the third year. After 3 years, clinical outcomes are monitored at least once a year until 5 years after treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm A (short course RT)
Patients undergo short course RT for 5-10 fractions over 1-2 weeks on study. Patients also receive temozolomide PO on days 1-5 every 28 days during radiation therapy. Starting one month post-radiation, patients continue temozolomide on days 1-5 every 28 days for up to 5 adjuvant cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT with 18-F-DOPA administered IV prior to RT on study, and undergo MRI prior to RT and throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
Accelerated Hypofractionated Radiation Therapy
Undergo short course RT
Computed Tomography
Undergo CT simulation
Fluorodopa F 18
Given IV
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaires
Temozolomide
Given PO
Biospecimen Collection
Undergo blood sample collection
Arm B (standard course RT)
Patients undergo standard course RT for 15-30 fractions over 3-6 weeks on study. Patients also receive temozolomide PO QD concurrently with radiation therapy and for up to 6 adjuvant cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT with 18-F-DOPA administered IV prior to RT on study, and undergo MRI prior to RT and throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
Computed Tomography
Undergo CT simulation
Fluorodopa F 18
Given IV
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaires
Radiation Therapy
Undergo standard course RT
Temozolomide
Given PO
Biospecimen Collection
Undergo blood sample collection
Interventions
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Accelerated Hypofractionated Radiation Therapy
Undergo short course RT
Computed Tomography
Undergo CT simulation
Fluorodopa F 18
Given IV
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaires
Radiation Therapy
Undergo standard course RT
Temozolomide
Given PO
Biospecimen Collection
Undergo blood sample collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological and/or molecular confirmation of glioblastoma
* Eastern Oncology Group (ECOG) performance status (PS) =\< 3
* Ability to complete questionnaire(s) by themselves or with assistance
* 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
* Willing to return to enrolling institution for follow-up either in-person or by video visit
* Postoperative/post-biopsy tumor plus surgical bed size =\< 6 cm in maximum diameter. This measurement includes both the enhancing region identified via T1 MRI with contrast, as well as the surgical cavity
Exclusion Criteria
* Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson's Disease, taking carbidopa/levodopa and/or less than 48 hours from discontinuance)
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Tumors with IDH mutation
* Previous brain radiation therapy
* Patients who will not receive any radiation treatment or who will receive radiation treatment elsewhere (Note: radiotherapy can be given on the trial at Mayo Clinic facilities in Rochester, Arizona, or Florida, as well as at the Mayo Clinic Health System sites). Temozolomide, however, can be provided by another institution
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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William G. Breen, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Roman O. Kowalchuk, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States
Mayo Clinic Radiation Therapy - Northfield
Northfield, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-01559
Identifier Type: REGISTRY
Identifier Source: secondary_id
GMROR2261
Identifier Type: OTHER
Identifier Source: secondary_id
22-006990
Identifier Type: OTHER
Identifier Source: secondary_id
GMROR2261
Identifier Type: -
Identifier Source: org_study_id
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