Brain TumorNCT01180881
Neurobehavioral Functioning in Pediatric Brain Tumor Patients After Proton Beam Radiation Treatment
An observational study of Brain Tumor and Central Nervous System Neoplasms, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Brain Tumor, Central Nervous System Neoplasms
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients who received proton radiation therapy at MGH
Who may be able to join
- 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
Who cannot join
- Patients receiving treatment with palliative intent
- Patients who do not wish to participate
- Patient is deceased at ≥1 year follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Neurobehavioral Functioning and Utilization of Special Education Services in Pediatric Brain and CNS Tumor Patients After Proton Radiation Treatment: A Longitudinal Study
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.
Read the 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.
- Conditions
- Brain Tumor, Central Nervous System Neoplasms
- Keywords
- Proton Radiation, CNS tumors, Brain Tumors, Neurobehavioral functioning
- Medical subject headings
- Brain Neoplasms, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Proton Radiation Patients at MGH | Pediatric brain and central nervous system (CNS) tumor patients treated with proton beam radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Rating Inventory of Executive Functioning
Questionnaire of executive functioning in children and young adults
Measured: Approximately one year post proton radiation treatment
Behavior Assessment System for Children
Questionnaire of behavioral functioning in children and young adults
Measured: Approximately one year following proton radiation treatment
Scales of Independent Behavior-Revised
Questionnaire of adaptive skills in children and young adults
Measured: Approximately one year following proton beam radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startOct 2009
- Primary completion31 Dec 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Pulsifer, Massachusetts General Hospital
- Investigators
- Margaret B. Pulsifer, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180881
- Sponsor's protocol ID
- 2009A058394
- Status last verified
- Nov 2025
- First submitted
- 11 Aug 2010
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grieco JA, Evans CL, Yock TI, Pulsifer MB. Psychosocial and executive functioning late effects in pediatric brain tumor survivors after proton radiation. Childs Nerv Syst. 2024 Nov;40(11):3553-3561. doi: 10.1007/s00381-024-06579-2. Epub 2024 Sep 2.
PubMed 39222091Pulsifer MB, Duncanson H, Grieco J, Evans C, Tseretopoulos ID, MacDonald S, Tarbell NJ, Yock TI. Cognitive and Adaptive Outcomes After Proton Radiation for Pediatric Patients With Brain Tumors. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):391-398. doi: 10.1016/j.ijrobp.2018.05.069. Epub 2018 Jun 6.
PubMed 30108004
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Functioning and Utilization of Special Education Services in Pediatric Brain and CNS Tumor Patients After Proton Radiation Treatment: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT01180881
- Acronym / sponsor ID
- 2009A058394
- Conditions
- Brain Tumor, Central Nervous System Neoplasms
- Keywords
- Proton Radiation, CNS tumors, Brain Tumors, Neurobehavioral functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Radiation Patients at MGH | – | –Pediatric brain and central nervous system (CNS) tumor patients treated with proton beam radiation therapy |
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients who received proton radiation therapy at MGH
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Patients receiving treatment with palliative intent
- Patients who do not wish to participate
- Patient is deceased at ≥1 year follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Behavior Rating Inventory of Executive Functioning
Time frame: Approximately one year post proton radiation treatment
Questionnaire of executive functioning in children and young adults
Behavior Assessment System for Children
Time frame: Approximately one year following proton radiation treatment
Questionnaire of behavioral functioning in children and young adults
Scales of Independent Behavior-Revised
Time frame: Approximately one year following proton beam radiation therapy
Questionnaire of adaptive skills in children and young adults
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Results publication: PubMed 39222091Grieco JA, Evans CL, Yock TI, Pulsifer MB. Psychosocial and executive functioning late effects in pediatric brain tumor survivors after proton radiation. Childs Nerv Syst. 2024 Nov;40(11):3553-3561. doi: 10.1007/s00381-024-06579-2. Epub 2024 Sep 2.
- Derived from this study: PubMed 30108004Pulsifer MB, Duncanson H, Grieco J, Evans C, Tseretopoulos ID, MacDonald S, Tarbell NJ, Yock TI. Cognitive and Adaptive Outcomes After Proton Radiation for Pediatric Patients With Brain Tumors. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):391-398. doi: 10.1016/j.ijrobp.2018.05.069. Epub 2018 Jun 6.
Related trials for Brain Tumor
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret B. Pulsifer, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Central Nervous System Neoplasms, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Rating Inventory of Executive Functioning (time frame: Approximately one year post proton radiation treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01180881, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.