Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

NCT05781321 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: GMROR2261NCI-2023-0155922-006990
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 8

Brief Summary

This phase II trial compares the effect of short course radiotherapy (RT) to standard course RT for the treatment of patients diagnosed with glioblastoma (GBM). The researchers want to learn whether the shorter course treatment is non-inferior (not worse than the standard of care), for patients with GBM. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Short course radiotherapy delivers higher doses of radiation over a shorter period of time and may kill more tumor cells and have fewer side effects.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Proportion of patients alive [overall survival (OS)] at 12 months

  OS is defined as the time from study registration to death due to any cause.

  Up to 12 months after enrollment

Secondary Outcomes (4)

• Proportion of patients whose radiation oncologist reported a grade 3+ toxicity

  30-, 90-, and 180-days post-radiotherapy (RT)

• Quality of life: EORTC QLQ-C30

  From baseline up to 3 years

• Quality of life: EORTC QLQ-BN20

  From baseline up to 3 years

• Lymphocyte count

  From baseline up to 3 years

Study Arms (2)

Arm A (short course RT)

EXPERIMENTAL

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.

Radiation: Accelerated Hypofractionated Radiation Therapy; Procedure: Computed Tomography; Drug: Fluorodopa F 18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Temozolomide; Procedure: Biospecimen Collection

Arm B (standard course RT)

ACTIVE COMPARATOR

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.

Procedure: Computed Tomography; Drug: Fluorodopa F 18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy; Drug: Temozolomide; Procedure: Biospecimen Collection

Interventions

Positron Emission Tomography PROCEDURE

Undergo PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Arm A (short course RT); Arm B (standard course RT)

Quality-of-Life Assessment OTHER

Ancillary studies

Arm A (short course RT); Arm B (standard course RT)

Questionnaire Administration OTHER

Complete questionnaires

Arm A (short course RT); Arm B (standard course RT)

Radiation Therapy RADIATION

Undergo standard course RT

Also known as: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Arm B (standard course RT)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Arm A (short course RT); Arm B (standard course RT)

Temozolomide DRUG

Given PO

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

Arm A (short course RT); Arm B (standard course RT)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

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

Arm A (short course RT); Arm B (standard course RT)

Accelerated Hypofractionated Radiation Therapy RADIATION

Undergo short course RT

Also known as: AHF-RT, AHRT

Arm A (short course RT)

Computed Tomography PROCEDURE

Undergo CT simulation

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Arm A (short course RT); Arm B (standard course RT)

Fluorodopa F 18 DRUG

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

Arm A (short course RT); Arm B (standard course RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• 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

You may not qualify if:

• Unable to undergo MRI scans with contrast
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (8)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007, United States

Location

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, 56001, United States

Location

Mayo Clinic Radiation Therapy - Northfield

Northfield, Minnesota, 55057, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic Health System-Eau Claire

Eau Claire, Wisconsin, 54701, United States

Location

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (1)

• Vora S, Pafundi D, Voss M, Buras M, Ashman J, Bendok B, Breen W, Hu L, Kizilbash S, Laack N, Liu W, Mahajan A, Mrugala M, Porter A, Ruff M, Sio T, Uhm J, Yang M, Brinkmann D, Brown P. Short-course hypofractionated proton beam therapy, incorporating 18F-DOPA PET and contrast-enhanced MRI targeting, for patients aged 65 years and older with newly diagnosed glioblastoma: a single-arm phase 2 trial. Lancet Oncol. 2024 Dec;25(12):1625-1634. doi: 10.1016/S1470-2045(24)00585-0. Epub 2024 Nov 18.

  PMID: 39571596 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glioblastoma

Interventions

fluorodopa F 18; Magnetic Resonance Spectroscopy; Radiotherapy; Radiation; Temozolomide; Specimen Handling

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Therapeutics; Physical Phenomena; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• William G. Breen, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

• Roman O. Kowalchuk, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The MRI scan indicating progressive disease will be fused with our treatment planning scan and the region of progression will be contoured by an investigator blinded to the GTV\ MRI, T2\ FLAIR\ NCET, GTV\ PET, PTV\ high, and isodose lines.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 23, 2023
• Study Start: March 23, 2023
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): July 2, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (8)