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A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma

NCT02125786 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-02-24

Study results available
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Summary

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

Interventions

RADIATION

Irradiation

Radiation therapy on this protocol will be based on extent of disease, extent of resection and location. The allowed treatment modalities include conformal or intensity-modulated radiation therapy using photons or proton therapy using double-scattering or spot-scanning methods. The general goal is to initiate radiation therapy within 12 weeks of last surgery performed at the time of recurrence.

PROCEDURE

Surgery

When applicable, surgery will be used to remove metastases. The goal of surgery is to achieve gross total resection of all imaging visible residual tumor.

DRUG

^1^8F-Fluorodeoxyglucose

This is a contrast media that will be given intravenously to aid in tumor visualization.

DRUG

^1^1C-methionine

This is a contrast media that will be given intravenously to aid in tumor visualization.

DEVICE

Photon therapy

Participants will receive one or both: Photon or proton therapy.

DEVICE

Proton therapy

Participants will receive one or both: Photon or proton therapy.

Sponsors & Collaborators

Principal Investigators

  • Thomas E. Merchant, DO, PhD · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-07
Primary Completion
2023-05-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02125786 on ClinicalTrials.gov