NRG-BN005

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

Status

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