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Maintenance Chemotherapy vs Observation for Ependymoma

Phase 3

Waitlist Available

Led By Amy A Smith

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Patients must be newly diagnosed with histologically confirmed intracranial ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO III) are eligible, as are various subtypes described as clear cell, papillary, cellular or a combination of the above

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well maintenance chemotherapy works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma.

Who is the study for?

This trial is for children and young adults aged 1-21 with newly diagnosed brain ependymoma, who've had surgery but no other treatment. It's not for those with spinal cord ependymoma or certain other types, pregnant or breastfeeding individuals, or patients with metastatic disease.Check my eligibility

What is being tested?

The study tests if maintenance chemotherapy after surgery and radiation helps more than just surgery and radiation alone in treating brain ependymoma. Some will receive combination chemotherapy drugs plus specialized radiation therapy aimed at killing tumor cells while sparing healthy tissue.See study design

What are the potential side effects?

Chemotherapy may cause side effects like nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, and potential damage to organs. Radiation therapy might lead to skin irritation at the treatment site and fatigue.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been newly diagnosed with a specific type of brain tumor called ependymoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years after enrollment. 5-year estimates of os are presented.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years after enrollment. 5-year estimates of os are presented.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years after enrollment. 5-year estimates of os are presented. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Secondary outcome measures

Event free survival (EFS) of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by post-operative induction chemotherapy or by second surgery

Event free survival (EFS) of children with supratentorial classic ependymoma who achieve complete resection at first or second surgery or children who achieve complete response (CR) after induction chemo assigned to observation

Gene expression signatures and genomic alterations in pediatric ependymoma

+4 more

Other outcome measures

EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

EFS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (radiotherapy, chemotherapy)Experimental Treatment8 Interventions

Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma who have undergone gross or near total resection (GTR or NTR) or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy. Maintenance chemotherapy comprised of vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization.

Group II: Arm I (chemotherapy, observation)Experimental Treatment7 Interventions

Patients with classic histology(WHO Grade II) supratentorial ependymoma who have undergone microscopic gross total resection (GTR1) or achieved CR either after first or second resection or after post-operative induction chemotherapy are assigned to observation. For patients without GTR1, induction chemotherapy is comprised of vincristine intravenously (IV) over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

Group III: ARM IV (radiotherapy, chemotherapy)Active Control8 Interventions

Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are nonrandomly assigned to Arm II treatment.

Group IV: Arm III (radiotherapy, observation)Active Control3 Interventions

Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) who have undergone gross or near total resection or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Etoposide

2010

Completed Phase 3

~2440

Mesna

2003

Completed Phase 2

~1380

Cisplatin

2013

Completed Phase 3

~1940

Cyclophosphamide

1995

Completed Phase 3

~3780

Filgrastim

2000

Completed Phase 3

~3670

3-Dimensional Conformal Radiation Therapy

2010

Completed Phase 3

~7160

Vincristine

2003

Completed Phase 4

~2910

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,674 Total Patients Enrolled

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,221 Total Patients Enrolled

Amy A SmithPrincipal InvestigatorChildren's Oncology Group

Media Library

3-Dimensional Conformal Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT01096368 — Phase 3

Brain Ependymoma Research Study Groups: Arm I (chemotherapy, observation), Arm II (radiotherapy, chemotherapy), ARM IV (radiotherapy, chemotherapy), Arm III (radiotherapy, observation)

Brain Ependymoma Clinical Trial 2023: 3-Dimensional Conformal Radiation Therapy Highlights & Side Effects. Trial Name: NCT01096368 — Phase 3

3-Dimensional Conformal Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01096368 — Phase 3

Frequently Asked Questions

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

Could you please list some other research done on 3-Dimensional Conformal Radiation Therapy?

"3-Dimensional Conformal Radiation Therapy was first studied in 1997 and, since then, 3353 completed studies have been carried out. As of now, there are 2054 live trials underway; a large majority of these taking place in Peoria, Illinois."

Answered by AI

What are the goals of this experiment?

"The goal of this trial is to measure Event-free survival (EFS) over a 5 year time frame. Secondary outcomes include Telomere maintenance and Overall survival (OS). Descriptive statistics, Log rank tests, and multivariate Cox proportional hazards models will be used to explore the association between telomere maintenance and EFS/OS. The reliability of human telomerase reverse transcriptase (hTERT) immunohistochemistry results versus telomeric repeat amplification protocol (TRAP) assay results will be calculated using the kappa statistic."

Answered by AI

At how many different locations is this trial currently taking place?

"The study's primary locations are Saint Jude Midwest Affiliate in Peoria, Illinois; Blank Children's Hospital in Des Moines, Iowa; and Tulane University Health Sciences Center in New Orleans, Louisiana. There are also satellite sites located throughout the country."

Answered by AI

How many people are total in this clinical trial?

"As of now, this trial is not looking for new patients. The first posting was on March 29th 2010 and the most recent edit was done on March 7th 2022. If you are interested in other studies, there are currently 52 trials related to ependymoma and 2054 investigating 3-Dimensional Conformal Radiation Therapy that have open enrolment."

Answered by AI

Can new patients still join this clinical research project?

"No, this study is not recruiting patients according to the information on clinicaltrials.gov. This trial was first posted almost 12 years ago and was last updated less than a year ago. There are over 2000 other trials that are currently seeking participants."

Answered by AI

Who meets the eligibility requirements for this research project?

"This study is open to 477 patients between the ages of 13 months and 20 who have a confirmed diagnosis of ependymoma. There are no minimum performance requirements for participants, as children with ependymoma may suffer from neurological complications as a result of their tumor or surgery. In most cases, there is potential for neurological recovery, which will not be impeded by protocol therapy. Patients must be newly diagnosed with histologically confirmed intracranial ependymoma in order to be eligible, and various subtypes (such as clear cell, papillary, cellular) are included. All patients and/or their parents"

Answered by AI

What are the risks associated with 3-Dimensional Conformal Radiation Therapy?

"There is prior clinical evidence affirming 3-Dimensional Conformal Radiation Therapy's safety, thus it received a score of 3."

Answered by AI

What are common issues that 3-Dimensional Conformal Radiation Therapy help alleviate?

"3-Dimensional Conformal Radiation Therapy is most effective in treating merkel cell cancer, but it can also be used as a treatment for leukemia, initial treatment, and prostate cancer."

Answered by AI

Are individuals outside of the age bracket of 40 years old being recruited for this test?

"This clinical trial only enrolls patients that are between 13 months and 20 years old. Out of the 4,218 similar studies found on clinicaltrials.gov, this is one of the few for people in this age group."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma

2010. "Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01096368.

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