Higher Doses of Hypofractionated Radiation Therapy for the Treatment of Elderly Patients with Glioblastoma, ELITE-GBM Trial

Inclusion Criteria

• Histologically proven diagnosis of glioblastoma
• Newly diagnosed disease, with time elapsed from diagnostic surgery/resection <8 weeks.
• Age ≥ 65 years old at time of glioblastoma diagnosis.
• Adequate functional status as measured by an ECOG performance status 0, 1 or 2, at time of enrollment.
• Platelet count ≥ 100 x 109^/L (100,000 cells/mm^3) (obtained within 45 days prior to randomization).
• Serum creatinine ≤ 1.5 times the upper limit of normal (obtained within 45 days prior to randomization).
• Total serum bilirubin ≤ 1.5 times the upper limit of normal (obtained within 45 days prior to randomization).
• Alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase [SGPT]) < 2.5 times the upper limit of normal and/or aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) < 2.5 times the upper limit of normal (obtained within 45 days prior to randomization).
• Patient may have received corticosteroids, but must be on a stable or decreasing dose for at least 14 days prior to randomization.

Exclusion Criteria

• Participants with recurrent glioma.
• Participants with evidence of spinal, leptomeningeal, or more distant disease.
• Participants with another active central nervous system malignancies requiring treatment.
• Participants with a second invasive malignancy that is A) incompletely treated or requiring ongoing treatment, or B) reasonably anticipated to be associated with a median overall survival of less than 1 year based on population-level data for the specified disease site and stage.
• Participants with any other major medical illnesses or psychiatric treatments that in the treating physician’s opinion will prevent administration or completion of protocol therapy.
• Participants with inadequate mental capacity to provide informed consent.
• Participants who cannot receive gadolinium.
• Participants who have undergone prior head and neck or cranial radiation or radiation to any other site previously that would be reasonably anticipated to result in a significant overlap in radiation fields.
• Participants who have received systemic or radiosensitizing therapy for a prior head and neck or central nervous system malignancy or any investigational cancer drug for glioblastoma prior to randomization.
• Participants who have received or plan to receive any other form of non-surgical local or field treatment overlapping with the anticipated radiation field.
• Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) or other acute medical conditions at the time of randomization that would impair the ability of the patient to receive protocol treatment.