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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Given LET optimized IMPT
Ancillary studies
Ancillary studies
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
NOT_YET_RECRUITINGM D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGIncidence 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
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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