Patient follow-up
death, tumor, Tumor, seizures, ±, allergy, renal dysfunction, Cancer
ADVERSE EVENT, TUMOR, TUMOR, ADVERSE EVENTS, DISEASE, ALLERGY, ADVERSE EVENT, CANCER
Participants were followed for three years according to standard-of-care intervals by neurologic and neurosurgical clinical assessments or until death. At 6 and 12 months after planned Visit 24 there was a phone call to assess survival status.Participants were assessed at follow-up visits following standard-of-care treatments and chemotherapy drugs were dispensed according to groups and cohorts. Drug compliance and adverse event assessment were performed. Lab work and brain imaging were collected at visits as per standard-of-care.The outpatient visits window was ± 7–14 days from the intended date of the visit. Follow-up visits consisted of a clinical evaluation with particular attention to neurological function, seizures, and corticosteroid use as per standard-of-care management of the disease. Laboratory tests of blood counts, glucose levels, and blood count, liver function tests indicated if the participant was receiving chemotherapy, corticosteroids, and anti-epileptic drugs.CT scan or MRI was performed as standard of care for the entire time patients are in the trial, and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. Imaging assessments were discontinued once a patient was off of the clinical trial, hospice, or death. Patients were followed for overall survival during the clinical trial.Participants were followed according to SOC intervals determined by neurologic and neurosurgical clinical assessments preferably with brain MRI scans pre- and post-intravenous gadolinium contrast unless the patient had a contraindication to gadolinium contrast then non-contrast brain MRI was obtained and or CT-scans of the brain pre and post intravenous contrast or without contrast, if the patient had a contraindication to CT intravenous contrast such as severe allergy and/or renal dysfunction.During treatment, adverse events were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0). Post-chemotherapy, patients had follow-up visits every 3 months, during which neurological function and corticosteroid levels were assessed and contrast-enhanced MRIs were performed (in addition to the post-surgery/baseline MRI).Response to chemotherapy was evaluated according to the 2D Response Assessment in Neuro-Oncology (RANO) criteria, in which in addition to contrast enhancement, tumor extension on T2-and fluid-attenuated inversion recovery (FLAIR)-weighted MRI are evaluated.Tumor assessments were performed by an independent neuro-radiology service composed of 2 readers and a third senior reader for adjudication of disagreements. All neuro-radiologists were blinded to groups and/or treatment assignments throughout the trial to determine the earliest time of progression independent of the impressions of the treating physicians to avoid bias.A record of all concomitant (OTC & prescription) taken 30 days prior to the screening visit through study termination was taken.