A Phase 1 interventional study of Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy and Quality-of-Life Assessment in Anaplastic Ependymoma and Ependymoma, sponsored by M.D. Anderson Cancer Center. Recruiting at 2 sites in United States. Open to participants aged Up to 22 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
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.
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.
224 studies on the registry are indexed under Ependymoma; 35 are open to participants now.
This study's planned enrollment of 48 is above the median of 28 across 174 interventional studies indexed under Ependymoma.
Browse Ependymoma studies →M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Given LET optimized IMPT
Also known as: LET-Optimized IMPT, LET-Optimized Intensity Modulated Proton Therapy, Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT)
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Incidence of adverse events
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.
Time frame: Up to 6 months post treatment
Identify imaging biomarkers of structural and biological changes after proton therapy
Descriptive statistics will be used to summarize the study data.
Time frame: Up to 24 months post-treatment
Quantitative image biomarkers
Descriptive statistics will be used to summarize the study data.
Time frame: Up to 24 months post-treatment
Validity of relative biological effectiveness models
Descriptive statistics will be used to summarize the study data.
Time frame: Up to 24 months post-treatment
Incidence of late and acute toxicities
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.
Time frame: Up to 24 months post treatment
Progression-free survival
The method of Kaplan and Meier will be used to provide estimates.
Time frame: Up to 24 months post treatment
Overall survival
The method of Kaplan and Meier will be used to provide estimates.
Time frame: Up to 24 months post treatment
Disease outcomes following the use of a simultaneous integrated boost
Descriptive statistics will be used to summarize the study data.
Time frame: Up to 24 months post-treatment
Started Apr 2019 (actual). Primary completion is estimated for Dec 2027, 104 months after the start.
Of 36 non-industry phase 1 interventional studies under Ependymoma, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 92. This study's planned 104 months is above that.
Counting every sponsor, half of 42 studies reached it within 62 months; a quarter within 39 and three quarters within 92.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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