Study on Surgery and Re-Irradiation for Recurrent Ependymoma

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60

ClinicalTrials ID:NCT02125786

This clinical trial is exploring whether surgery combined with a second round of radiation therapy can help treat ependymoma, a type of brain tumor, that has returned after initial treatment. The study will also look at the effects and side effects of this treatment approach.

Patient Parameters

Parameter	Options

Program Overview

The main goal of this study is to find out if surgery and a second round of radiation therapy can effectively treat ependymoma that has come back after the first treatment. The total radiation dose will be higher than usual, and researchers will monitor the effects and side effects. They will also study tumor and blood samples to learn more about the tumor's response to treatment. MRI and PET scans will be used to predict how the tumor responds and if it comes back. Participants will be followed for up to 5 years, with evaluations during radiation therapy and regular check-ups after treatment.

Description

This study involves treating patients with recurrent ependymoma using surgery and a second course of radiation therapy. Patients will be grouped based on their diagnosis and previous treatments:

Group 1: Tumor has returned only at the original site; patients aged over 12 months to under 21 years. Treatment: focused radiation.
Group 2: Tumor has spread without returning to the original site; patients aged over 36 months to under 21 years. Treatment: radiation to the brain and spine.
Group 3: Tumor has returned and spread; patients aged over 36 months to under 21 years. Treatment: radiation to the brain and spine.
Group 4: Tumor has returned only at the original site with specific genetic changes; patients aged over 36 months to under 21 years. Treatment: optional radiation to the brain and spine.

Primary Objective:

To estimate how long children and young adults with recurrent ependymoma live without the disease getting worse after receiving a second round of radiation, while monitoring for any severe brain damage.

Secondary Objectives:

To explore how treatment affects neurological, hormonal, and cognitive functions.
To study the impact of sleep, fatigue, and quality of life on treatment outcomes.
To evaluate physical performance and movement changes after treatment.
To assess tumor response and brain effects using advanced imaging techniques.

Exploratory Objectives:

To study tumor activity using PET scans before and after treatment.
To analyze growth factors and cytokines in response to treatment.
To conduct molecular analyses on tumor and blood samples to understand ependymoma biology and treatment effects.
To explore the impact of chemotherapy given before re-irradiation on survival outcomes.
To compare survival outcomes for patients with specific genetic changes treated with a second round of radiation.

Eligibility Criteria

Inclusion Criteria

Have a recurrent ependymoma in the brain after previous radiation treatment.
Be between 1 and 21 years old at the time of joining the study.
Be in good overall health and not require a ventilator.
Have at least 9 months between the start of initial radiation therapy and joining the study.

Exclusion Criteria

Have had previous radiation to the brain and spine.
Be pregnant, as radiation can harm the unborn baby.
Be under 3 years old with a tumor that has spread.

Locations

FACILITY	ZIP	CITY	STATE
St. Jude Children's Research Hospital	38105	Memphis	Tennessee

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