LET Optimized IMPT in Treating Pediatric Patients With Ependymoma (NCT03750513) | Clinical Trial Compass
RecruitingPhase 1
LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
United States48 participantsStarted 2019-04-01
Plain-language summary
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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily designed to measure the safety of LET-optimized proton therapy rather than to prove it works better, what does that mean for weighing the potential risks against the possible benefits for my child?
2This trial uses a specific type of proton radiation called LET-optimized intensity-modulated proton therapy — how is that different from the standard radiation my child might receive outside of a trial, and why might that difference matter for treating ependymoma?
3What kinds of adverse events are researchers watching for most closely in this study, and how would side effects be managed if my child experienced them during treatment?
4Are there standard-of-care radiation treatments already proven for pediatric ependymoma that we should consider first before enrolling in a Phase 1 trial, and how would you compare those options to what this study is testing?
5What would participating in this trial actually look like week to week for my child — how many visits, how long is the treatment course, and is the proton therapy facility close enough to make this logistically realistic for our family?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.