LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
NCT ID: NCT03750513
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2019-04-01
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (LET optimized IMPT)
Patients receive LET optimized IMPT for up to 6 weeks.
Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
Given LET optimized IMPT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
Given LET optimized IMPT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Ependymoma of the spine
* Disseminated ependymoma requiring craniospinal radiation therapy
* Pregnancy
* Inability to undergo MR imaging
* Inability to receive gadolinium-based contrast agent
22 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David R Grosshans
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Kaden L Mitra Litzinger
Role: primary
David R. Grosshans
Role: primary
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-02519
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0344
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0344
Identifier Type: -
Identifier Source: org_study_id