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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Year - 25 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01180881
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Massachusetts General Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Margaret B. Pulsifer, PhD
Principal Investigator Affiliation	Massachusetts General Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor, Central Nervous System Neoplasms

Additional Details

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.#46; 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.#46; 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.

Arms & Interventions

Arms

: Proton Radiation Patients at MGH

Pediatric brain and central nervous system (CNS) tumor patients treated with proton beam radiation therapy

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114