Clinical trial NCT05658731: Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
Official title: Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumor
Head and Neck Cancer
Keywords: radiation therapy
pediatric
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Clark Charitable Foundation
First posted: 2022-12-21
Enrollment: 338
Sex: ALL
Minimum age (years): 1
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility 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. Exclusion Criteria

      * 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
3. STRATUM C

   1. Eligibility Criteria

      * must be aged 5 to \<26 years of age
      * must be able to complete research imaging without sedation
   2. Exclusion Criteria

      * must not have any major psychiatric, neurologic or medical diagnosis

Primary outcomes:
measure: Number of plans that meet substructure-informed planning constraints
timeFrame: 1 month
Secondary outcomes:
measure: Cumulative incidence of local and distant tumor recurrence
timeFrame: up to 5 years after treatment
measure: Fractional anisotropy values
timeFrame: baseline to two years
measure: 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.
timeFrame: baseline to 3 years
measure: 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.
timeFrame: baseline to 5 years
measure: characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
timeFrame: baseline to 5 years
measure: characterize longitudinal NIH toolbox scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
timeFrame: baseline to 5 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Sahaja Acharya, MD
role: PRINCIPAL_INVESTIGATOR
References: