PRIMARY OBJECTIVE:~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 absolutely 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 over 1-2 weeks on study.~ARM B: Patients undergo standard course RT over 3-6 weeks on study.~Patients in arms A and B also receive temozolomide orally (PO) on study, undergo positron emission tomography/computed tomography (PET/CT) with 18-F-DOPA administered intravenously (IV) prior to RT on study, and undergo MRI throughout the trial.
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.