Overview

This trial is active, not recruiting.

Conditions brain tumor, central nervous system neoplasms
Sponsor Massachusetts General Hospital
Start date October 2009
End date March 2016
Trial size 150 participants
Trial identifier NCT01180881, 2009A058394

Summary

The aim of this study is to follow up with all of the pediatric brain tumor patients who received proton beam radiation therapy at Massachusetts General Hospital (MGH) for which there is baseline neuropsychological testing in order to measure changes, if any, in neurobehavioral functioning (executive skills, emotional/behavioral functioning, and adaptive abilities) and their use of special education services at one year or more post-treatment. The investigators will also correlate neurobehavioral data with pertinent clinical information. Participation will be maximized through the use of mail-in, parental- and self-report questionnaires.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Pediatric brain and central nervous system (CNS) tumor patients treated with proton beam radiation therapy

Primary Outcomes

Measure
Behavior Rating Inventory of Executive Functioning
time frame: Approximately one year post proton radiation treatment
Behavior Assessment System for Children
time frame: Approximately one year following proton radiation treatment
Scales of Independent Behavior-Revised
time frame: Approximately one year following proton beam radiation therapy

Eligibility Criteria

Male or female participants from 2 years up to 25 years old.

Inclusion Criteria: 1. Children diagnosed with brain or CNS tumors and treated with proton radiation therapy at the MGH Francis H. Burr Proton Center since September 2002 2. Patients received baseline neurocognitive testing at MGH 3. Patients ≤25 years at the time of diagnosis 4. Tumor location in the brain or CNS 5. Radiation treatment consisted of only proton radiotherapy 6. No prior radiation exposure or chemotherapy Exclusion Criteria: 1. Patients receiving treatment with palliative intent 2. Patients who do not wish to participate 3. Patient is deceased at ≥1 year follow-up

Additional Information

Official title Neurobehavioral Functioning and Utilization of Special Education Services in Pediatric Brain and CNS Tumor Patients After Proton Radiation Treatment: A Longitudinal Study
Principal investigator Margaret B. Pulsifer, PhD
Description The purpose of this study is to longitudinally examine neurobehavioral functioning outcomes and use of special education services in brain tumor and CNS tumor patients treated with proton radiation at MGH. Furthermore, we seek to correlate neurobehavioral data with pertinent clinical information. We anticipate better neurobehavioral functioning to be associated with use of protons (vs. photons, as reported in the literature). We also anticipate the need and utilization of special education services to be lower in brain and CNS tumor patients treated with protons (vs. photons, as reported in the literature). Lastly, we anticipate greater neurobehavioral deficits in patients whose proton radiation treatment involved the craniospinal axis compared to those who received proton radiation to the involved field.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.