LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
Anaplastic Ependymoma · Ependymoma
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 1
- Age range
- Not specified - 22 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 48 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This phase I trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therapy such as LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.
Read the full description
PRIMARY OBJECTIVES:
I. To evaluate the safety of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) (bio-IMPT) for pediatric patients with ependymoma.
SECONDARY OBJECTIVES:
I. To utilize advanced multiparametric magnetic resonance (MR) imaging to identify imaging biomarkers of structural and biological changes after proton therapy in pediatric ependymoma patients.
II. To compare quantitative image biomarkers in patients treated with bio-IMPT and standard proton therapy using a voxel level analysis.
III. To test and evaluate the validity of relative biological effectiveness (RBE) models and enhance their precision based on prospectively collected clinical image biomarkers.
IV. To evaluate acute and late toxicities, including pseudoprogression and symptom burden, in patients treated with bio-IMPT.
V. To estimate progression-free survival (PFS) and overall survival (OS). VI. To evaluate disease outcomes following the use of a simultaneous integrated boost (SIB) for pediatric ependymoma patients with gross residual disease following surgery.
OUTLINE:
Patients receive LET optimized IMPT for up to 6 weeks.
After completion of study treatment, patients are followed up at 1 month, then every 3 months for up to 24 months.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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 Criteria:
- 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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Treatment (LET optimized IMPT)
Patients receive LET optimized IMPT for up to 6 weeks.
Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy RADIATION
Given LET optimized IMPT
Quality-of-Life Assessment OTHER
Ancillary studies
Questionnaire Administration OTHER
Ancillary studies
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Incidence of adverse events
Time frame: Up 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.
Secondary measures
Identify imaging biomarkers of structural and biological changes after proton therapy
Time frame: Up to 24 months post-treatment
Descriptive statistics will be used to summarize the study data.
Quantitative image biomarkers
Time frame: Up to 24 months post-treatment
Descriptive statistics will be used to summarize the study data.
Validity of relative biological effectiveness models
Time frame: Up to 24 months post-treatment
Descriptive statistics will be used to summarize the study data.
Incidence of late and acute toxicities
Time frame: Up to 24 months post treatment
Descriptive statistics will be used to summarize the study data. For each study cohort, we will tabulate treatment- failures and other relevant clinically-related features. Interval estimates for proportions will be provided using exact 95% confidence intervals.
Progression-free survival
Time frame: Up to 24 months post treatment
The method of Kaplan and Meier will be used to provide estimates.
Overall survival
Time frame: Up to 24 months post treatment
The method of Kaplan and Meier will be used to provide estimates.
Disease outcomes following the use of a simultaneous integrated boost
Time frame: Up to 24 months post-treatment
Descriptive statistics will be used to summarize the study data.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
2 locations
Massachusetts General Hospital Cancer CenterBoston, Massachusetts, United StatesNot yet recruiting
M D Anderson Cancer CenterHouston, Texas, United StatesRecruiting
Study team and timeline
- Lead sponsor
- M.D. Anderson Cancer Center
- Study start
- Apr 1, 2019 Actual
- Primary completion
- Dec 31, 2027 Estimated
- Study completion
- Dec 31, 2027 Estimated
- First posted
- Nov 23, 2018 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026