LET Optimized IMPT for Pediatric Ependymoma

This study is looking at the side effects of a type of radiation therapy called Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy (LET optimized IMPT) in children and young adults (up to 22 years old) with ependymoma. Ependymoma is a type of brain tumor. The goal is to see how safe this treatment is and if it can shrink tumors without harming healthy tissues nearby. Researchers will also look for changes in the brain after treatment using special MRI scans and track how patients are doing over time. To join, you must have a confirmed diagnosis of ependymoma (WHO grade II or III) that is only in the brain and not receiving chemotherapy at the same time as radiation. The study's status is currently unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 48 participants.
What's involved
Participants will receive LET optimized IMPT for up to 6 weeks. They will also complete quality-of-life assessments and questionnaires.
Compensation
Not stated in the trial record.
Follow-up
After treatment, participants will have follow-up visits at 1 month, then every 3 months for up to 24 months.

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NCT03750513

LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

Recruiting
PHASE1Up to 22InterventionalTreatment
M.D. Anderson Cancer Center
~48 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Linear Energy Transfer-Optimized Intensity Modulated Proton TherapyQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 6 months post treatment
Anaplastic Ependymoma
Ependymoma
2 sites across 2 states
Massachusetts1
Texas1
  • David R Grosshans · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Inclusion

Previous pathologic confirmation of ependymoma, World Health Organization (WHO) grade II or III
Disease must be confined to the brain (no evidence of spread on MR imaging of the spine or on staging lumbar puncture)
Patient may not receive chemotherapy concurrent with radiation
Signed informed consent by patient and/or parents or legal guardian
Lansky performance status score of 50 -100

Exclusion

Patients with previous radiation therapy to the brain
Ependymoma of the spine
Disseminated ependymoma requiring craniospinal radiation therapy
Pregnancy
Inability to undergo MR imaging
Inability to receive gadolinium-based contrast agent
  • Incidence of adverse eventsUp to 6 months post treatment

    The safety of linear energy transfer-optimized intensity modulated proton therapy will be defined by treatment failures which include imaging changes consistent with necrosis in the presence of Common Terminology Criteria for Adverse Events version 4.03 symptoms of grade 3 brain necrosis and/or local recurrence within the first 6 months from the end of proton therapy.