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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
Must not have
Patients with evidence of metastatic disease will be excluded; any evidence of non-contiguous spread beyond the primary site as determined by pre or post-operative magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar CSF space (the requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated); CSF cytology from a ventriculostomy or permanent ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative of metastatic disease
Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 9, 30, and 60 months post diagnosis
Awards & highlights

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have cancer spread beyond the primary site as confirmed by MRIs and CSF tests.
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I am using effective birth control.
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I am a woman who has started menstruating and have a negative pregnancy test.
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I do not have a spinal cord tumor diagnosis like ependymoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 9, 30, and 60 months post diagnosis
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 9, 30, and 60 months post diagnosis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 study objectives
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
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~2360
Cyclophosphamide
2010
Completed Phase 4
~2320
Etoposide
2010
Completed Phase 3
~2960
Filgrastim
2000
Completed Phase 3
~3690
Mesna
2003
Completed Phase 2
~1380
Vincristine
2003
Completed Phase 4
~2970

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,521 Total Patients Enrolled
Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,351 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
~31 spots leftby Sep 2025
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