Clinical trial · Interventional
LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma
NCT03750513CI-TRIAL-00112138recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Ependymoma | Anaplastic Ependymoma | ONTOLOGY_EXACT | 0.90 |
| Ependymoma | Ependymoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy | Radiation | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (LET optimized IMPT)
- description
- Patients receive LET optimized IMPT for up to 6 weeks.
- interventionNames
- Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Incidence of adverse events
- timeFrame
- Up to 6 months post treatment
- description
- 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.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 22 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.