Stereotactic Accelerated Radiotherapy in GlioblastomA (SAGA)

Trial ID: NCT05781321

Interventional - Phase 2 - Active, not recruiting

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

Interventions

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

Eligibility

Inclusion criteria

• 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
• 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

Exclusion criteria

• 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

Sponsor

Mayo Clinic

Source: ClinicalTrials.gov

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