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

Active, not recruiting

• Conditions: Brain Tumor; Central Nervous System Neoplasms

• Registration Number: NCT01180881
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Behavior Assessment System for Children	Approximately one year following proton radiation treatment	Questionnaire of behavioral functioning in children and young adults
Behavior Rating Inventory of Executive Functioning	Approximately one year post proton radiation treatment	Questionnaire of executive functioning in children and young adults
Scales of Independent Behavior-Revised	Approximately one year following proton beam radiation therapy	Questionnaire of adaptive skills in children and young adults

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States