This study investigates the feasibility of reducing radiation doses to the hippocampi (hippocampal-avoidance) using proton therapy in pediatric patients with low-grade gliomas and explores whether hippocampal-avoidance is associated with preservation of neurocognition.
Low-grade gliomas are the most common brain tumors in children, and a subset of these tumors are treated definitively with focal radiation therapy. These patients often survive for many years after treatment and experience late deficits in memory. Verbal recall is an important measure of memory and is associated with other important functional outcomes, such as problem-solving, independence of every-day functioning and quality of life. Decline in memory, as measured by verbal recall, is associated with radiation dose to the hippocampi.
In this study, all patients will be planned with hippocampus-avoidance proton therapy and neurocognitive outcomes will be collected at baseline and continue to 5 years after completion of therapy.
- To determine the feasibility of hippocampal avoidance with proton therapy in suprasellar or midline low-grade gliomas
- To estimate the 3-year event-free survival for low-grade gliomas treated with hippocampal avoidance
- To estimate the change in California Verbal Learning Test (CLVT-SD) short-term delay from baseline to 3 years and from baseline to 5 years
- To compare CLVT-SD and Cogstate neurocognitive scores in patients with proton therapy plans that: (1) meet first priority radiation therapy (RT) dose constraints, (2) meet second priority RT dose constraints but not first priority RT dose constraints, and (3) that did not meet either first or second RT priority dose constraints
Inclusion criteria include:
- At least 6 years old and younger than 22 years old
- Diagnosis of one of the following:
- Pilocytic astrocytoma
- Pilomyxoid astrocytoma
- Pleomorphic xanthoastrocytoma
- Optic pathway glioma
- Diffuse astrocytoma
- Low-grade neuroepithelial tumor
- Low-grade glioneuronal tumor
- Low-grade glioma
- Tumor located in suprasellar region or midline structures
- No concurrent chemotherapy or targeted therapy, including but not limited to BRAF-inhibitors and MEK-inhibitors
- Must be able to undergo contrast-enhanced brain MRI
Exclusion Criteria include:
- Pregnant or breastfeeding
- Prior CNS radiation
- Gross total resection and no measurable disease
- Evidence of metastatic disease
- WHO grade II midline tumor with H3K27M mutation, IDH-mutant glioma, grade II ependymoma and subependymoma, pituicytoma, spindle cell oncocytoma or granular cell tumor of the sellar region
- Tumor that directly invades bilateral hippocampi or gross tumor volume extending into bilateral hippocampi
St. Jude Children’s Research Hospital, Memphis, Tennessee
Collaborating sites in the U.S.
About this study
This study examines how a specific proton therapy radiation treatment affects memory and learning in young patients with low-grade glioma brain tumors. Radiation therapy is a standard treatment for low-grade gliomas. Proton therapy is a type of radiation therapy.
In this study, the proton therapy will be designed to avoid the part of the brain called the hippocampus. The hippocampus is important for memory and thinking. Other studies have shown that memory is preserved in adult patients when radiation therapy avoids the hippocampus. There is no proof of this in children, adolescents and young adults.
You may or may not benefit from taking part in this study. However, you may help doctors learn more about your cancer which may help children and adolescents in the future.
Purpose of this clinical trial
The main purpose of this study is to find out what happens, good and bad, to memory and learning when the hippocampus is avoided during proton therapy radiation.
- At least 6 years old and younger than 22
- Diagnosis of low-grade glioma
HALGG Quick View Sponsor St. Jude Children’s Research Hospital ClinicalTrials.gov identifier NCT04065776 Trial start date
67 (including all sites) Study type Interventional Study phase Phase II Conditions Low-grade glioma Ages Between 6 and 22 years old Principal investigator Thomas Merchant, DO, PhD Study site St. Jude Children’s Research Hospital & collaborating sites outside the U.S. For a consultation or to discuss HALGG St. Jude Physician/Patient Referral Office
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