Brain Tumor, Head and Neck Cancer
Conditions
Keywords
radiation therapy, pediatric
Brief summary
The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients. Patients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study. Survivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed. Healthy children will also be enrolled and have research MRIs done. The researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.
Interventions
RADIATIONsubstructure informed planning
Radiation Therapy with substructure informed planning determined by the PI.
California Verbal Learning Test (CVLT) and other cognition assessments.
DIAGNOSTIC_TESTMRI
Magnetic resonance imaging (MRI) using whole brain diffusion tensor imaging (DTI) and resting state functional MRI (rsfMRI).
Sponsors
United States Department of Defense
Clark Charitable Foundation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Stratum A: patients with new diagnosis of brain or head and neck cancer who will be undergoing radiation therapy with substructure informed planning Stratum B: patients ≥ 2 years from radiation therapy for brain tumor who underwent standard planning radiation therapy Stratum C: healthy controls matched to Stratum A patients
Eligibility
Sex/Gender
ALL
Age
1 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
1. STRATUM A 1. Eligibility Criteria * aged 1 to \<26 years of age * tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit * treatment must include radiation therapy (either proton or photon) * patients must not have completed radiation therapy 2.
Exclusion criteria
* pregnancy * patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism 2. STRATUM B 1. Eligibility Criteria * diagnosed with a brain tumor at \<26 years of age * received radiation to the brain as part of therapy * time from radiation start to study enrollment is ≥ 2 years * there has not been disease recurrence from time of most recent radiation treatment to study enrollment 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of plans that meet substructure-informed planning constraints | 1 month | Number of plans that meet substructure-informed constraints (per protocol) divided by the total number of plans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fractional anisotropy values | baseline to two years | This outcome will measure changes in connection strength within brain networks. Fractional anisotropy values range from 0 to 1. Higher numbers are better. |
| compare the change in California Verbal Learning Test (CVLT) in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A. | baseline to 3 years | Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better. |
| Cumulative incidence of local and distant tumor recurrence | up to 5 years after treatment | Calculate the cumulative incidence of local and distant tumor recurrence. Local and tumor recurrence is determined by imaging and clinical symptoms. |
| characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation | baseline to 5 years | Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better. |
| characterize longitudinal NIH toolbox scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation | baseline to 5 years | Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better. |
| compare the change in NIH toolbox scores in patients whose radiation plans meet the dose constraints compared to those who do not for all patients in Stratum A. | baseline to 5 years | Scores are age-standardized and with a mean of 100 and standard deviation of 15. Higher scores are better. |
Countries
United States
Contacts
Primary ContactSahaja Acharya, MD
Backup ContactKatie Lowe
Outcome results
None listed