Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial

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.