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

NCT02125786 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: RERTEPNCI-2014-00906
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Ependymoma

Outcome Measures

Primary Outcomes (2)

• 3-year Progression-free Survival Rate

  To prospectively estimate the progression-free distribution for children and young adults with recurrent ependymoma treated with a second course of irradiation.

  2 years follow-up after initiation of radiation therapy for the last patient enrolled

• 3-year Overall Survival Rate

  OS was calculated from the date of initial radiation therapy to date of death or date of last contact for the patients who were treated with RT. The event of interest was death.

  2 years follow-up after initiation of radiation therapy for the last patient enrolled

Secondary Outcomes (24)

• Incidence Rate of Neurological Deficits

  Through 5 years after initiation of second course of irradiation

• Incidence Rate of Ophthalmological Deficits

  Through 5 years after initiation of second course of irradiation

• Incidence Rate of Audiological Deficits

  Through 5 years after initiation of second course of irradiation

• Incidence Rate of Endocrine Deficits

  Through 5 years after initiation of second course of irradiation

• Number of Neurocognitive Deficits

  Through 5 years after initiation of second course of irradiation

Other Outcomes (7)

• Avidity of Ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET Prior to Radiation Therapy

  Baseline

• Longitudinal Change of Avidity of Ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET Prior to Radiation Therapy

  12, 24 and 36 months after second course of irradiation

• Longitudinal Change of Necrosis Measured With MET/FDG and Necrosis Measured With MRI

  Baseline, and at 12, 24 and 36 month

Study Arms (4)

Stratum 1: Local Failure

EXPERIMENTAL

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.

Radiation: Irradiation; Procedure: Surgery; Drug: ^1^8F-Fluorodeoxyglucose; Drug: ^1^1C-methionine; Device: Photon therapy; Device: Proton therapy

Stratum 2: Metastatic Failure

EXPERIMENTAL

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.

Radiation: Irradiation; Procedure: Surgery; Drug: ^1^8F-Fluorodeoxyglucose; Drug: ^1^1C-methionine; Device: Photon therapy; Device: Proton therapy

Stratum 3: Local and Metastatic Failure

EXPERIMENTAL

Participants exhibit an initial pattern of failure that is both local and metastatic (neuraxis metastatic disease with equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. 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.

Radiation: Irradiation; Procedure: Surgery; Drug: ^1^8F-Fluorodeoxyglucose; Drug: ^1^1C-methionine; Device: Photon therapy; Device: Proton therapy

Stratum 4: Local Failure

EXPERIMENTAL

Local Failure Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Age is \>36 months at time of enrollment to \<21 years. Tumor shows presence of 1q gain. Treatment is optional craniospinal irradiation. 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.

Radiation: Irradiation; Procedure: Surgery; Drug: ^1^8F-Fluorodeoxyglucose; Drug: ^1^1C-methionine; Device: Photon therapy; Device: Proton therapy

Interventions

Surgery PROCEDURE

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.

Also known as: Metastasectomy

Stratum 1: Local Failure; Stratum 2: Metastatic Failure; Stratum 3: Local and Metastatic Failure; Stratum 4: Local Failure

Irradiation RADIATION

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.

Also known as: Focal irradiation, Craniospinal irradiation

Stratum 1: Local Failure; Stratum 2: Metastatic Failure; Stratum 3: Local and Metastatic Failure; Stratum 4: Local Failure

^1^8F-Fluorodeoxyglucose DRUG

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

Also known as: 18F-FDG, Contrast Media

Stratum 1: Local Failure; Stratum 2: Metastatic Failure; Stratum 3: Local and Metastatic Failure; Stratum 4: Local Failure

^1^1C-methionine DRUG

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

Also known as: Contrast Media

Stratum 1: Local Failure; Stratum 2: Metastatic Failure; Stratum 3: Local and Metastatic Failure; Stratum 4: Local Failure

Photon therapy DEVICE

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

Also known as: Photon linear accelerator

Stratum 1: Local Failure; Stratum 2: Metastatic Failure; Stratum 3: Local and Metastatic Failure; Stratum 4: Local Failure

Proton therapy DEVICE

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

Also known as: Proton synchroton

Stratum 1: Local Failure; Stratum 2: Metastatic Failure; Stratum 3: Local and Metastatic Failure; Stratum 4: Local Failure

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Ependymoma

Interventions

Radiation; Craniospinal Irradiation; Surgical Procedures, Operative; Metastasectomy; Fluorodeoxyglucose F18; Contrast Media; Proton Therapy

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Physical Phenomena; Radiotherapy; Therapeutics; Deoxyglucose; Deoxy Sugars; Carbohydrates; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Heavy Ion Radiotherapy

Results Point of Contact

• Title: Thomas E. Merchant, DO, PhD
• Organization: St. Jude Children's Research Hospital

referralinfo@stjude.org

8662785833

Study Officials

• Thomas E. Merchant, DO, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 29, 2014
• Study Start: May 7, 2014
• Primary Completion: May 1, 2023
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 24, 2026
• Results First Posted: November 12, 2024

Record last verified: 2026-02

Locations

US (1)