LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy, Quality-of-Life Assessment, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Anaplastic Ependymoma, Ependymoma. Basic parameters: up to 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma
Overview
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.
Detailed 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.
Interventions
- Radiation Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
Given LET optimized IMPT - Other Quality-of-Life Assessment
Ancillary studies - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Incidence of adverse events [Time frame: Up to 6 months post treatment]
Secondary outcome measures (7)
- Identify imaging biomarkers of structural and biological changes after proton therapy [Time frame: Up to 24 months post-treatment]
- Quantitative image biomarkers [Time frame: Up to 24 months post-treatment]
- Validity of relative biological effectiveness models [Time frame: Up to 24 months post-treatment]
- Incidence of late and acute toxicities [Time frame: Up to 24 months post treatment]
- Progression-free survival [Time frame: Up to 24 months post treatment]
- Overall survival [Time frame: Up to 24 months post treatment]
- Disease outcomes following the use of a simultaneous integrated boost [Time frame: Up to 24 months post-treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Massachusetts General Hospital Cancer Center — Boston
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT03750513 · 2018-0344 · NCI-2018-02519 · 2018-0344 · P30CA016672 · U19CA021239