Skip to content
Triangle logo TriangleGet started
← Study library

NCT01096368 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2026-04-30

The primary aim of this randomized phase III trial was to study whether the addition of maintenance chemotherapy delivered after surgical resection and focal radiation would be better than surgery and focal radiation alone. The trial also studied if patients who received induction chemotherapy and then either achieved a complete response or went on to have a complete resection would also benefit from maintenance chemotherapy. Children ages 1-21 years with newly diagnosed intracranial ependymoma were included. There were 2 arms that were not randomized. One arm studied patients with Grade II tumors located in the supratentorial compartment that were completely resected. One arm studied patients with residual tumor and those patients all received maintenance chemotherapy after focal radiation. Chemotherapy drugs, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy in combination with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

OS in Children With Incomplete Resection After Initial Surgery Who Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

→

outcome · POSTED

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

→

outcome · POSTED

OS 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

→

outcome · POSTED

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 and Who Are Non-randomly Assigned to Observation

→

outcome · POSTED

OS 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 and Who Are Non-randomly Assigned to Observation

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * 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 * There is no minimum performance level; children with ependymoma may suffer neurologic sequelae as a result of their tumor or surgical measures taken to establish a diagnosis and resect the tumor; in the majority of cases, there is neurologic recovery; neurologic recovery is not likely to be impeded by protocol therapy * REGULATORY: All patients and/or their parents or legal guardians must sign a written informed consent * REGULATORY: All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: * 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 * Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible * No prior treatment other than surgical intervention and corticosteroids; patients are allowed to have had more than one attempt at resection prior to enrollment * Pregnant female patients are not eligible for this study * Post-menarchal females may not participate unless a pregnancy test with a negative result has been obtained * Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * Lactating females may not participate unless they have agreed not to breastfeed a child while on this study
healthy Volunteers
false
maximum Age
21 Years
minimum Age
12 Months
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Carboplatin
    2. Drug: Cyclophosphamide
    3. Drug: Etoposide
    4. Biological: Filgrastim
    5. Other: Laboratory Biomarker Analysis
    6. Drug: Mesna
    7. Drug: Vincristine
    label
    Arm I (chemotherapy, observation)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Radiation: 3-Dimensional Conformal Radiation Therapy
    2. Drug: Cisplatin
    3. Drug: Cyclophosphamide
    4. Drug: Etoposide
    5. Biological: Filgrastim
    6. Other: Laboratory Biomarker Analysis
    7. Drug: Mesna
    8. Drug: Vincristine
    label
    Arm II (radiotherapy, chemotherapy)
    type
    EXPERIMENTAL
  3. description
    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.
    intervention Names
    1. Radiation: 3-Dimensional Conformal Radiation Therapy
    2. Other: Clinical Observation
    3. Other: Laboratory Biomarker Analysis
    label
    Arm III (radiotherapy, observation)
    type
    ACTIVE_COMPARATOR
  4. description
    Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are nonrandomly assigned to Arm II treatment.
    intervention Names
    1. Radiation: 3-Dimensional Conformal Radiation Therapy
    2. Drug: Cisplatin
    3. Drug: Cyclophosphamide
    4. Drug: Etoposide
    5. Biological: Filgrastim
    6. Other: Laboratory Biomarker Analysis
    7. Drug: Mesna
    8. Drug: Vincristine
    label
    ARM IV (radiotherapy, chemotherapy)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. ARM IV (radiotherapy, chemotherapy)
    2. Arm II (radiotherapy, chemotherapy)
    3. Arm III (radiotherapy, observation)
    description
    Patients undergo conformal radiotherapy
    name
    3-Dimensional Conformal Radiation Therapy
    other Names
    1. 3-dimensional radiation therapy
    2. 3D Conformal
    3. 3D CONFORMAL RADIATION THERAPY
    4. 3D CRT
    5. 3D radiotherapy
    6. 3D-CRT
    7. Conformal Therapy
    8. Radiation Conformal Therapy
    9. Radiation, 3D Conformal
    10. Three dimensional external beam radiation therapy (procedure)
    type
    RADIATION
  2. arm Group Labels
    1. Arm I (chemotherapy, observation)
    description
    Given IV
    name
    Carboplatin
    other Names
    1. Blastocarb
    2. Carboplat
    3. Carboplatin Hexal
    4. Carboplatino
    5. Carboplatinum
    6. Carbosin
    7. Carbosol
    8. Carbotec
    9. CBDCA
    10. Displata
    11. Ercar
    12. JM-8
    type
    DRUG
  3. arm Group Labels
    1. ARM IV (radiotherapy, chemotherapy)
    2. Arm II (radiotherapy, chemotherapy)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  4. arm Group Labels
    1. Arm III (radiotherapy, observation)
    description
    Patients undergo observation
    name
    Clinical Observation
    other Names
    1. observation
    type
    OTHER
  5. arm Group Labels
    1. ARM IV (radiotherapy, chemotherapy)
    2. Arm I (chemotherapy, observation)
    3. Arm II (radiotherapy, chemotherapy)
    description
    Given IV
    name
    Cyclophosphamide
    other Names
    1. (-)-Cyclophosphamide
    2. 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    3. Asta B 518
    4. B 518
    5. B-518
    6. B518
    7. Carloxan
    8. Ciclofosfamida
    9. Ciclofosfamide
    10. Cicloxal
    11. Clafen
    12. Claphene
    type
    DRUG
  6. arm Group Labels
    1. ARM IV (radiotherapy, chemotherapy)
    2. Arm I (chemotherapy, observation)
    3. Arm II (radiotherapy, chemotherapy)
    description
    Given IV
    name
    Etoposide
    other Names
    1. Demethyl Epipodophyllotoxin Ethylidine Glucoside
    2. EPEG
    3. Lastet
    4. Toposar
    5. Vepesid
    6. VP 16
    7. VP 16-213
    8. VP 16213
    9. VP-16
    10. VP-16-213
    11. VP-16213
    12. VP16
    type
    DRUG
  7. arm Group Labels
    1. ARM IV (radiotherapy, chemotherapy)
    2. Arm I (chemotherapy, observation)
    3. Arm II (radiotherapy, chemotherapy)
    description
    Given SC or IV
    name
    Filgrastim
    other Names
    1. Filgrastim Biosimilar Filgrastim-sndz
    2. Filgrastim Biosimilar Tbo-filgrastim
    3. Filgrastim XM02
    4. Filgrastim-aafi
    5. Filgrastim-ayow
    6. Filgrastim-sndz
    7. G-CSF
    8. Granix
    9. Neupogen
    10. Neutroval
    11. Nivestim
    12. Nivestym
    type
    BIOLOGICAL
  8. arm Group Labels
    1. ARM IV (radiotherapy, chemotherapy)
    2. Arm I (chemotherapy, observation)
    3. Arm II (radiotherapy, chemotherapy)
    4. Arm III (radiotherapy, observation)
    description
    Optional correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  9. arm Group Labels
    1. ARM IV (radiotherapy, chemotherapy)
    2. Arm I (chemotherapy, observation)
    3. Arm II (radiotherapy, chemotherapy)
    description
    Given IV
    name
    Mesna
    other Names
    1. 2-Mercaptoethanesulfonate, Sodium Salt
    2. Ausobronc
    3. D-7093
    4. Filesna
    5. Mercaptoethane Sulfonate
    6. Mercaptoethanesulfonate
    7. Mesnex
    8. Mesnil
    9. Mesnum
    10. Mexan
    11. Mistabron
    12. Mistabronco
    type
    DRUG
  10. arm Group Labels
    1. ARM IV (radiotherapy, chemotherapy)
    2. Arm I (chemotherapy, observation)
    3. Arm II (radiotherapy, chemotherapy)
    description
    Given IV
    name
    Vincristine
    other Names
    1. LCR
    2. Leurocristine
    3. VCR
    4. Vincrystine
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
479
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval.
    measure
    EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
    time Frame
    Up to 10 years after enrollment. 5-year estimates of EFS are presented.
  2. description
    Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval.
    measure
    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
    time Frame
    Up to 10 years after enrollment. 5-year estimates of EFS are presented.
  3. description
    Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval.
    measure
    OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only.
    time Frame
    Up to 10 years after enrollment. 5-year estimates of OS are presented.
  4. description
    Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval.
    measure
    OS in Children With Incomplete Resection After Initial Surgery Who Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
    time Frame
    Up to 10 years after enrollment. 5-year estimates of OS are presented.
  5. description
    The Kaplan-Meier estimate of EFS is calculated from enrollment date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause.
    measure
    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
    time Frame
    Up to 10 years after enrollment. 5-year estimates of EFS are presented.
  6. description
    The Kaplan-Meier estimate of OS is calculated from enrollment date to death from any cause.
    measure
    OS 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
    time Frame
    Up to 10 years after enrollment. 5-year estimates of OS are presented.
  7. description
    The Kaplan-Meier estimate of EFS is calculated from enrollment date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause.
    measure
    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 and Who Are Non-randomly Assigned to Observation
    time Frame
    Up to 10 years after enrollment. 5-year estimates of EFS are presented.
  8. description
    The Kaplan-Meier estimate of OS is calculated from enrollment date to death from any cause.
    measure
    OS 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 and Who Are Non-randomly Assigned to Observation
    time Frame
    Up to 10 years after enrollment. 5-year estimates of OS are presented.
primary Outcomes
  1. description
    Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) is conveyed by the hazard ratio and 90.46% stagewise adjusted Wald confidence interval.
    measure
    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
    time Frame
    Up to 10 years after enrollment. 5-year estimates of EFS are presented
  2. description
    Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) is conveyed by the hazard ratio and 90.46% stagewise adjusted Wald confidence interval.
    measure
    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
    time Frame
    Up to 10 years after enrollment. 5-year estimates of OS are presented.
Full study description
brief Summary
The primary aim of this randomized phase III trial was to study whether the addition of maintenance chemotherapy delivered after surgical resection and focal radiation would be better than surgery and focal radiation alone. The trial also studied if patients who received induction chemotherapy and then either achieved a complete response or went on to have a complete resection would also benefit from maintenance chemotherapy. Children ages 1-21 years with newly diagnosed intracranial ependymoma were included. There were 2 arms that were not randomized. One arm studied patients with Grade II tumors located in the supratentorial compartment that were completely resected. One arm studied patients with residual tumor and those patients all received maintenance chemotherapy after focal radiation. Chemotherapy drugs, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy in combination with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.
detailed Description
PRIMARY OBJECTIVE: I. To determine the event free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with post-operative conformal radiation therapy (cRT) and then randomized to receive or not receive four cycles of post radiation maintenance chemotherapy (vincristine, cisplatin, etoposide and cyclophosphamide \[VCEC\]). EXPLORATORY OBJECTIVES: I. To estimate the EFS and OS of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by post-operative induction chemotherapy or by second surgery who will then be non-randomly assigned to cRT followed by four cycles of maintenance chemotherapy (VCEC). II. To further evaluate the EFS and OS of children with supratentorial classic ependymoma who achieve a complete resection at first or second resection OR children who achieve a CR to short course induction chemotherapy following first surgery. III. To evaluate whether the addition of maintenance chemotherapy post-radiation therapy contributes to neurobehavioral morbidity and reduced functional outcomes over time, compared to patients treated with radiation therapy followed by observation alone. IV. To examine differences in neurobehavioral outcomes and quality of life of children treated with proton beam radiation therapy compared to children treated with conventional radiation delivery techniques. V. To evaluate biologic prognostic factors in childhood ependymoma by studying molecular groups as defined by deoxyribonucleic acid (DNA) methylation profiling and immunohistochemistry, copy number variants to identify 1q gain in posterior fossa ependymomas, CDKN2A loss (homozygous deletion) in supratentorial ependymomas and specific genetic alterations such as RELA fusions, YAP1 fusions and the H3 K27M mutation on initial tumor samples and correlating these data with clinical outcome. Va. To explore prognostic molecular signatures and genomic alterations in ependymomas by building upon the data derived from ACNS0121 to correlate biomarkers listed above with World Health Organization (WHO) grade, location, extent of resection, treatment, EFS and OS. OUTLINE: This is a multicenter study partially randomized phase III study. Patients are randomized or non-randomly treated according to tumor location and extent of surgical resection or post-surgery induction chemotherapy response. Arm I: 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. ARM II: 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. ARM III: 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. ARM IV: Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are non-randomly assigned to Arm II treatment. After completion of study therapy, patients are followed up every 4 months for 5 years, and then annually thereafter.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-a5e347fad0a5a1030d2c
      requested nct id
      NCT01096368
      primary nct id
      NCT01096368
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      38c24293d77035737c36f373ad34727063c379ad0f1689b82e0576633709aa6e
      payload sha256
      3794fe9dc073606700472b892b4608ff7398fd036231545258829dc71e00ad65
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-a5e347fad0a5a1030d2c
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT01096368
      occurrences
      1. context exact
        n with newly diagnosed ependymomas that are completely resected. The utility of adjuvant chemotherapy was studied in the completed COG <a href="/clinicaltrials/NCT01096368">ACNS0831 (NCT01096368)</a> trial. Published results of this trial are forthcoming. There is no evidence that myeloablative chemotherapy [<a href="#cit/secti
        end
        143304
        exact text
        NCT01096368
        start
        143293
      2. context exact
        ependymomas that are completely resected. The utility of adjuvant chemotherapy was studied in the completed COG <a href="/clinicaltrials/NCT01096368">ACNS0831 (NCT01096368)</a> trial. Published results of this trial are forthcoming. There is no evidence that myeloablative chemotherapy [<a href="#cit/section_8.25">25</a>] improv
        end
        143327
        exact text
        NCT01096368
        start
        143316
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/0a7d16ec0a90d008ac.html
      source file sha256
      38c24293d77035737c36f373ad34727063c379ad0f1689b82e0576633709aa6e
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:33.171240+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      5d2ee80edd757a2d8dac89105101cf4b01f94cfb1ae99fdb55ae34213559c647
      source title
      Childhood Ependymoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: January 6, 2025
        datetime
        2025-01-06T12:00:00Z
        display
        January 6, 2025

    Preserved source evidence · Not medical advice