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Radiation Therapy

Surgery + Re-Irradiation for Recurrent Ependymoma

Q: Has there been any research like this before?

There are currently 22 ongoing clinical trials related to Surgery taking place in 15 cities and 5 countries. Studies on Surgery began in 2007 with Baxter Healthcare Corporation's Phase 4 drug approval stage involving 4640 patients. To date, 140 such trials have been completed.

Q: Do octogenarians still qualify for this research project?

The age requirements to enroll in this trial are between 1 and 21 years old. Out of the 80 total clinical trials, 52 of them allow for patients under 18 and 28 have an age cap at 65+.

Q: What are the FDA's current thoughts on surgery?

Power has given surgery a 2 out of 3 in terms of safety. This is due to the fact that this is only a phase 2 trial, so while there is some evidence supporting its safety, there is no data backing up its efficacy.

Q: What types of ailments is Surgery most often used as a cure-all for?

Surgery is the most popular intervention for left ventricular dysfunction. Other potential applications for surgery include treating seizures, epileptic episodes, and hepatic encephalopathy.

Q: Has this surgical method been tested before in other patients?

As of now, there are 22 clinical studies for Surgery active with 1 in Phase 3. Most of these medical trials take place in Wuhan, Hubei; however, there are a total of 29 locations running different parts of the trial.

Q: Are volunteers needed for this research project?

Unfortunately, this particular clinical trial is not presently looking for new patients. Although, if you check the site again in the future, that could change as the last update was on October 28th, 2022. In total, there are 74 other trials currently accepting patients.

Q: Can I take part in this clinical research project?

This ependymoma study will take in 70 patients that are between 1 year and 21 years old. They must have good performance status (ECOG &#x3C; 3), not require mechanical ventilation, and the interval from start of initial radiation therapy to enrollment > 9 months.

Phase 2

Waitlist Available

Led By Thomas E. Merchant, DO, PhD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Progressive intracranial ependymoma after prior focal irradiation

Adequate performance status (ECOG < 3) and research participant does not require mechanical ventilation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years after initiation of irradiation for the last patient enrolled

Awards & highlights

Study Summary

This trial is for people with ependymoma that has come back after initial treatment. Surgery and re-irradiation with higher than usual doses of radiation will be used to try to treat the tumor. Tumor tissue and blood will be studied to learn more about the tumor and how it responds to treatments.

Who is the study for?

This trial is for individuals aged 1-21 with recurrent ependymoma, a type of brain tumor, after initial radiation treatment. They must be at least 9 months post-initial therapy and able to perform daily activities without mechanical ventilation. Pregnant women, patients who had prior full-spine irradiation or are under 3 years old with metastatic ependymoma cannot participate.Check my eligibility

What is being tested?

The study tests if surgery combined with higher-than-usual doses of re-irradiation can treat recurring ependymoma. It includes analyzing tumor tissue and blood samples, using MRI and PET scans to monitor the tumor's response to treatments over a period of up to five years.See study design

What are the potential side effects?

Potential side effects may include typical risks associated with surgery and radiation such as fatigue, skin irritation at the irradiated site, hair loss in the treated area, nausea, headaches, and more serious complications like damage to surrounding healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain tumor has grown despite previous radiation treatment.

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I can care for myself and do not need a machine to help me breathe.

Select...

I am between 1 and 21 years old.

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It has been over 9 months since my first radiation treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, and at 12, 24 and 36 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, and at 12, 24 and 36 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and at 12, 24 and 36 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

3-year overall survival rate

3-year progression-free survival rate

Secondary outcome measures

Change over time in imaging metrics

Incidence rate of audiological deficits

Incidence rate of endocrine deficits

+21 more

Other outcome measures

3 year overall survival (OS) rates by chemotherapy groups

3-year progression-free survival (PFS) rates by chemotherapy groups

Avidity of ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET prior to radiation therapy

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Stratum 4: Local FailureExperimental Treatment6 Interventions

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.

Group II: Stratum 3: Local and Metastatic FailureExperimental Treatment6 Interventions

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.

Group III: Stratum 2: Metastatic FailureExperimental Treatment6 Interventions

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.

Group IV: Stratum 1: Local FailureExperimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irradiation

2015

N/A

~490

Proton therapy

2011

N/A

~30

Surgery

2000

Completed Phase 3

~2550

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,543 Total Patients Enrolled

8 Trials studying Ependymoma

1,639 Patients Enrolled for Ependymoma

Thomas E. Merchant, DO, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital

2 Previous Clinical Trials

518 Total Patients Enrolled

1 Trials studying Ependymoma

378 Patients Enrolled for Ependymoma

Media Library

Irradiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02125786 — Phase 2

Ependymoma Research Study Groups: Stratum 3: Local and Metastatic Failure, Stratum 2: Metastatic Failure, Stratum 1: Local Failure, Stratum 4: Local Failure

Ependymoma Clinical Trial 2023: Irradiation Highlights & Side Effects. Trial Name: NCT02125786 — Phase 2

Irradiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02125786 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been any research like this before?

"There are currently 22 ongoing clinical trials related to Surgery taking place in 15 cities and 5 countries. Studies on Surgery began in 2007 with Baxter Healthcare Corporation's Phase 4 drug approval stage involving 4640 patients. To date, 140 such trials have been completed."

Answered by AI

Do octogenarians still qualify for this research project?

"The age requirements to enroll in this trial are between 1 and 21 years old. Out of the 80 total clinical trials, 52 of them allow for patients under 18 and 28 have an age cap at 65+."

Answered by AI

What are the FDA's current thoughts on surgery?

"Power has given surgery a 2 out of 3 in terms of safety. This is due to the fact that this is only a phase 2 trial, so while there is some evidence supporting its safety, there is no data backing up its efficacy."

Answered by AI

What types of ailments is Surgery most often used as a cure-all for?

"Surgery is the most popular intervention for left ventricular dysfunction. Other potential applications for surgery include treating seizures, epileptic episodes, and hepatic encephalopathy."

Answered by AI

Has this surgical method been tested before in other patients?

"As of now, there are 22 clinical studies for Surgery active with 1 in Phase 3. Most of these medical trials take place in Wuhan, Hubei; however, there are a total of 29 locations running different parts of the trial."

Answered by AI

Are volunteers needed for this research project?

"Unfortunately, this particular clinical trial is not presently looking for new patients. Although, if you check the site again in the future, that could change as the last update was on October 28th, 2022. In total, there are 74 other trials currently accepting patients."

Answered by AI

Can I take part in this clinical research project?

"This ependymoma study will take in 70 patients that are between 1 year and 21 years old. They must have good performance status (ECOG < 3), not require mechanical ventilation, and the interval from start of initial radiation therapy to enrollment > 9 months."

Answered by AI

How many participants are being enrolled in this experiment?

"Recruitment for this study has stopped. The trial was first advertised on May 7th, 2014 and the most recent update to the posting occurred on October 28th, 2022. Currently, there are 52 other ependymoma trials recruiting patients and 22 studies related to Surgery also have open enrollments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2014. "A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02125786.

All > Ependymoma