A Phase II Randomized Trial of Proton vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas.
Principal Investigator
David Grosshans, MD
Status
Closed to Accrual
Date Opened To Accrual
August 02 2017
Date Closed to Accrual
March 19 2024
Disease Site
Brain [BN]
Lower Grade Glioma
Phase
II
Developmental Therapeutics
No
Primary Objective
To determine whether proton therapy, compared to IMRT, preserves cognitive outcomes over time as measured by the Clinical Trial Battery Composite (CTB COMP) score (calculated from the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall, HVLT-R Delayed Recall, HVLT-R Delayed Recognition, Controlled Oral Word Association (COWA) test, Trail Making Test (TMT) Part A and Part B
Patient Population
Histologically proven diagnosis of supratentorial, WHO grade II or III astrocytoma, oligodendroglioma or oligoastrocytoma, with IDH mutation confirmed by central review prior to step 2 registration.
Target Accrual
120