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Completed

NCT Number: NCT01180881

Neurobehavioral Functioning in Pediatric Brain Tumor Patients After Proton Beam Radiation Treatment

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.

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Key information

Age range

1 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children diagnosed with brain or CNS tumors and treated with proton radiation therapy at the MGH Francis H. Burr Proton Center since September 2002
  • Patients received baseline neurocognitive testing at MGH
  • Patients ≤25 years at the time of diagnosis
  • Tumor location in the brain or CNS
  • Radiation treatment consisted of only proton radiotherapy
  • No prior radiation exposure or chemotherapy

Exclusion criteria

  • Patients receiving treatment with palliative intent
  • Patients who do not wish to participate
  • Patient is deceased at ≥1 year follow-up

Treatment and study plan

Primary outcomes

  1. Behavior Rating Inventory of Executive Functioning

    Time frame: Approximately one year post proton radiation treatment

    Questionnaire of executive functioning in children and young adults

  2. Behavior Assessment System for Children

    Time frame: Approximately one year following proton radiation treatment

    Questionnaire of behavioral functioning in children and young adults

  3. Scales of Independent Behavior-Revised

    Time frame: Approximately one year following proton beam radiation therapy

    Questionnaire of adaptive skills in children and young adults

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Neurobehavioral Functioning and Utilization of Special Education Services in Pediatric Brain and CNS Tumor Patients After Proton Radiation Treatment: A Longitudinal Study

Important dates

Study start
2009
Primary completion
2017
Study completion
2018
First posted
Aug 12, 2010
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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