COG ACNS 1833 Phase III Clinical Trial Comparing Functional and Quality of Life Outcomes after Selumetinib vs. Carboplatin/Vincristine in Children with Newly Diagnosed Low-Grade Glioma

Award: $400,000 over 2 years (2020 – 2022)
Principal Investigators: Dr. Peter de Blank, Cincinnati Children’s Hospital, Dr. Heather Conklin, St. Jude Children’s Research Hospital

In order to comprehensively compare CV and selumetinib treatment regimens, we will evaluate quality of life, cognitive, functional, and behavioral outcomes in children with newly diagnosed low-grade glioma. Because overall survival for low-grade glioma is typically excellent, understanding the impact of treatment regimens on quality of life and function is essential. Aim 1: Compare the change in quality of life, measured by the PedsQL generic module, following treatment with either selumetinib or carboplatin/vincristine in children with previously untreated low-grade glioma. Aim 2: Prospectively evaluate and compare the change in cognitive function measured by the BRIEF Cognitive Regulation Index between baseline and 12 months in children treated with either therapy. Aim 3: Determine whether visual acuity in children with previously untreated OPG is better after treatment with selumetinib or carboplatin/vincristine, using Teller Acuity Cards and HOTV letter acuity testing. Aim 4: Compare the improvement in motor function as measured by the Vineland Scale in children with previously-untreated LGG treated with either therapy that have motor deficits at enrollment.