NCT03750513 LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
| NCT ID | NCT03750513 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Anaplastic Ependymoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2019-04-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2019-04-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
David R Grosshans
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT03750513 clinical trial?
This trial is open to participants of all sexes, up to 22 Years, studying Anaplastic Ependymoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03750513 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03750513 currently recruiting?
Yes, NCT03750513 is actively recruiting participants. Contact the research team at dgrossha@mdanderson.org for enrollment information.
Where is the NCT03750513 trial being conducted?
This trial is being conducted at Boston, United States, Houston, United States.
Who is sponsoring the NCT03750513 clinical trial?
NCT03750513 is sponsored by M.D. Anderson Cancer Center. The principal investigator is David R Grosshans at M.D. Anderson Cancer Center. The trial plans to enroll 48 participants.