An interventional study of Proton Beam in Brain Tumor, sponsored by Massachusetts General Hospital. Active, not recruiting at 2 sites in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation.
The radiation involved in this study is:
-Proton Radiation
This research study is a Pilot Study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. This is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation.
The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this specific disease but it has been approved for other uses.
In this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. The standard of care for this procedure is photon radiation, which is very similar to proton radiation. The investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue
Exclusion Criteria:
* Patients will be treated with Proton Beam once daily 5 days per week. * Doses will be prescribed such that maximum possible coverage is achieved
Radiation: Proton Beam
precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue
Feasibility of cranio-spinal irradiation (CSI) utilizing intensity-modulated proton therapy (IMPT) with pencil beam scanning (PBS) for vertebral body sparing (VBS) in pediatric patients.
IMPT using PBS delivery will be considered to be feasible as a VBS technique for CSI in pediatric patients if the rate of grade 3/4 hematologic toxicity were no more than 5% within 3 months after the completion of radiation treatment, within the range associated with conventional techniques of CSI. Toxicity will be assess using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time frame: 3 months
Early marrow changes in the vertebral bodies
Summary of early marrow changes in the vertebral bodies by Magnetic resonance imaging (MRI) of the spine during radiation therapy (RT) by comparing one study MRI to the baseline pre-RT MRI.
Time frame: 2 years
Vertebral column growth (measured by MRI) over 1 year
Summary of vertebral column growth (measured by MRI) over 1 year following vertebral body sparing cranio-spinal irradiation in pediatric patients.
Time frame: Last day of treatment to 1 year later
Change in sitting height and standing height
Summary of the changes in the participants sitting and standing heights.
Time frame: Annually for 5 years
Time to abnormality in spinal curvature
Participants are monitored both clinically and by MRI for any abnormality in spinal curvature. The time to abnormality in spine curvature will be measured from the start of radiation to the date of documented abnormality or censored at the date of last follow-up for patients still alive with normal spine.
Time frame: 5 years
Disease Free Survival
Disease-free survival is measured from the start of radiation to the date of progressive disease based on imaging studies obtained as standard care or to the date of death due to any cause, whichever is earlier. Disease-free survival will be estimated using the Kaplan-Meier method. Patients without progressive disease and still alive will be censored at their date of last contact.
Time frame: 5 years
Pattern of Disease Relapse
Summary of the sites where the cancer relapses. Relapse is the regrowth of cancer cells.
Time frame: 2 years
Complete blood counts (CBC) over time
Summary of the change in complete blood counts (CBC) over time as determined by yearly blood samples.
Time frame: Annually for 5 years
Change in levels of vitamin D, calcium, and growth hormones over time
Summary of the changes in blood levels of vitamin D, calcium, and growth hormones.
Time frame: Annually for 5 years
Weight
Summary of the changes in weight of the participants as assessed by yearly evaluations.
Time frame: Annually for 5 years
BMI
Summary of the body mass index (BMI) of the participants as assessed by yearly physical evaluations.
Time frame: Annually for 5 years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital