Clinical trial · Interventional
A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma
A Phase II Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma
- 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)
The primary purpose of this study is to investigate whether surgery and re-irradiation will help treat ependymoma that has come back after initial treatment. The combined doses of the first and second courses of radiation are higher than what is usual standard of care. The investigators will study the effects and side effects of surgery and re-irradiation. They will also evaluate and study tumor tissue and blood to learn more about the tumor and how it does or does not respond to treatments and will use magnetic resonance imaging (MRI) and positron emission tomography (PET) scans to see if they can predict tumor response and tumor recurrence. Participants will be followed for up to 5 years following enrollment. Evaluations during radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and every 6 months during the 4th and 5th year.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ependymoma | Ependymoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ^1^1C-methionine | Drug | — | UNRESOLVED |
| ^1^8F-Fluorodeoxyglucose | Drug | — | UNRESOLVED |
| Irradiation | Radiation | — | UNRESOLVED |
| Photon therapy | Device | — | UNRESOLVED |
| Proton therapy | Device | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Stratum 1: Local Failure
- description
- Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Treatment is surgery and a second course of focal irradiation. The total dose for the second course of irradiation will be 54Gy. Participants may receive one or both: Photon therapy or proton therapy. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine to aid in tumor visualization.
- interventionNames
- Radiation: Irradiation
- Procedure: Surgery
- Drug: ^1^8F-Fluorodeoxyglucose
- Drug: ^1^1C-methionine
- Device: Photon therapy
- Device: Proton therapy
- type
- EXPERIMENTAL
- label
- Stratum 2: Metastatic Failure
- description
- Participants exhibit an initial pattern of failure that is metastatic (neuraxis metastatic disease without equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Craniospinal irradiation (36-39.6Gy) will include focal boost treatment of metastatic sites (54-59.4Gy) depending on location, extent of resection and target volume. Participants may receive one or both: Photon therapy or proton therapy. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine to aid in tumor visualization.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Progressive intracranial ependymoma after prior focal irradiation * Patients aged 1-21 years at the time of enrollment * Adequate performance status (ECOG \< 3) and research participant does not require mechanical ventilation * Interval from start of initial radiation therapy to enrollment \> 9 months Exclusion Criteria: * Prior craniospinal irradiation * Pregnant women are excluded from enrollment on this study because radiation therapy is an agent with the potential for teratogenic or abortifacient effects * Any patient with both metastatic ependymoma and age \< 3 years at the time of enrollment
References
Publications (0)
Data not yet available