NCT00027846 · CITED IN SOURCE DOCUMENTS

Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma

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

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2019-08-07

RATIONALE: 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma.

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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

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baseline

Baseline characteristics

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outcome · POSTED

Event-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy

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outcome · POSTED

Event-free Survival (EFS)

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outcome · POSTED

Event-free Survival (EFS)

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outcome · POSTED

Local Control and Patterns of Failure

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed intracranial ependymoma * Differentiated ependymoma or anaplastic ependymoma * No primary spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma * No evidence of noncontiguous spread beyond primary site * Initial surgical resection within the past 56 days PATIENT CHARACTERISTICS: Age: * 1 to 21 Performance status: * No restrictions Life expectancy: * At least 2 months Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Able to undergo MRI * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior or concurrent corticosteroids allowed Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics * More than 1 prior surgery allowed Other: * No other prior treatment for ependymoma
healthy Volunteers: false
maximum Age: 21 Years
minimum Age: 1 Year
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
Patients undergo observation.
label
GTR1 Differentiated Histology Supratentorial (Group 1)
type
NO_INTERVENTION
description
Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
intervention Names
Radiation: radiation therapy
label
Radiation (Group 2)
type
EXPERIMENTAL
description
Patients receive an initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.
intervention Names
Biological: filgrastim
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: vincristine sulfate
Radiation: radiation therapy
Drug: Mesna
Procedure: therapeutic conventional surgery
label
Sub-Total Resection Any Histology or Location (STR) (Group 3)
type
EXPERIMENTAL

interventions

arm Group Labels
Sub-Total Resection Any Histology or Location (STR) (Group 3)
description
Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously.
name
filgrastim
other Names
G CSF, G-CSF, granulocyte colony stimulating factor, granulocyte colony-stimulating factor
type
BIOLOGICAL
arm Group Labels
Sub-Total Resection Any Histology or Location (STR) (Group 3)
description
Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patients with BSA \<0.45m2 the dose is 12.5 mg/kg/day.
name
carboplatin
other Names
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA,
type
DRUG
arm Group Labels
Sub-Total Resection Any Histology or Location (STR) (Group 3)
description
Given IV (1000mg/m2/day) Day 1 and 2 given as an IV infusion over one hour following carboplatin administration. For patients with BSA\<0.45m2 the dose is 33mg/kg/day on Day 1 and 2.
name
cyclophosphamide
other Names
Neosar, Procytox, Sendoxan, Syklofosfamid, WR-138719, Zytoxan
type
DRUG
arm Group Labels
Sub-Total Resection Any Histology or Location (STR) (Group 3)
description
Given orally (50 mg/m2/day) orally once daily on Days 1 through 21. For patients with BSA \< 0.45 m2, the dosage is 1.7 mg/kg/day on Days 1 through 21.
name
etoposide
other Names
Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, epipodophyllotoxin, Lastet, Toposar, VePesid
type
DRUG
arm Group Labels
Sub-Total Resection Any Histology or Location (STR) (Group 3)
description
Given IV or orally (1.5mg/m2/day) (maximum dose 2 mg) Day 1 and 8 given as IV bolus. For patients with BSA\<0.45m2 the dose is 0.05mg/kg.
name
vincristine sulfate
other Names
22-oxovincaleukoblastine, 57-22-7, leurocristine sulfate, VCR, Vincasar PFS
type
DRUG
arm Group Labels
Radiation (Group 2)
Sub-Total Resection Any Histology or Location (STR) (Group 3)
description
Given once daily 5 days a week for 6-6½ weeks
name
radiation therapy
other Names
irradiation, radiotherapy, therapy, radiation
type
RADIATION
arm Group Labels
Sub-Total Resection Any Histology or Location (STR) (Group 3)
description
Mesna (200mg/m2/dose) Day 1 and 2. For patients with BSA\<0.45m2 the dose is (7mg/kg/dose). Combine mesna (200mg/m2) with cyclophosphamide and administer intravenously over one hour followed by mesna (200mg/m2) in 375 cc/m2 D5-1/2NS and run intravenously over 3 hours at 125cc/m2/hr. After 3 hour mesna, administer mesna (200 mg/m2/dose) IV over 15 minutes at hour 5.
name
Mesna
type
DRUG
arm Group Labels
Sub-Total Resection Any Histology or Location (STR) (Group 3)
name
therapeutic conventional surgery
type
PROCEDURE

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 378
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.
measure
Event-free Survival
time Frame
Up to 5 years after completion of study treatment

secondary Outcomes

description
Overall survival (OS) is measured from the date of study enrollment to the date to death. The product-limit (Kaplan-Meier) estimate is for estimation of OS probability at 5 years.
measure
Overall Survival
time Frame
Up to 5 years after completion of study treatment
description
The Rate Of Gross-Total or Near-Total Resection With Second Surgery After Chemotherapy Treatment.
measure
Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy
time Frame
At the time of second surgery
description
EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who had sub-total resection initially. The event-free survival (EFS) defined as the date of disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start date of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability.
measure
Event-free Survival (EFS)
time Frame
At 5 years since the time of radiation therapy.
description
EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma for the patients who were treated with radiation therapy only. The event-free survival (EFS) defined as the time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, measured from the start of radiation therapy. The product-limit (Kaplan-Meier) estimate is for estimation of EFS probability at 5 years.
measure
Event-free Survival (EFS)
time Frame
At 5 years since the time of radiation therapy
description
Documented and analyzed qualitatively and quantitatively.
measure
Local Control and Patterns of Failure
time Frame
Up to 5 years after completion of study treatment

Full study description

brief Summary: RATIONALE: 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma.
detailed Description: OBJECTIVES: * Determine the local control and pattern of failure in children with completely resected, differentiated, supratentorial localized ependymoma after initial surgical resection alone. * Determine the rate of complete resection with second surgery after chemotherapy in patients with initially incompletely resected localized ependymoma. * Determine the local control and pattern of failure in patients treated with conformal radiotherapy. * Determine the influence of histologic grade on the time to progression in patients after treatment with conformal radiotherapy. OUTLINE: This is a multicenter study. Patients are stratified according to extent of prior surgical resection. * Group 1 (patients with supratentorial differentiated ependymoma who have undergone gross total resection and have no visible residual tumor): Patients undergo observation. * Group 2 (patients with supratentorial anaplastic ependymoma or infratentorial anaplastic or differentiated ependymoma who have undergone gross total resection or near total resection): Patients undergo conformal radiotherapy to the brain once daily 5 days a week for 6-6½ weeks. * Group 3 (patients with tumor of any histology or location who have undergone subtotal resection): Patients receive an initial course of chemotherapy comprising vincristine IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second surgery. Patients who have unresectable disease undergo conformal radiotherapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. Patients are followed every 4 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 250-350 patients will be accrued for this study within 5 years.

Source references

Source notices and limitations

Discovery and provenance

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ce of avoiding or deferring radiation in children younger than 3 years. In a prospective Children’s Oncology Group (COG) trial (<a href="/clinicaltrials/NCT00027846">ACNS0121 [NCT00027846]</a>), immediate postoperative radiation therapy was given to all children older than 1 year after gross-total resection or near-total
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ring radiation in children younger than 3 years. In a prospective Children’s Oncology Group (COG) trial (<a href="/clinicaltrials/NCT00027846">ACNS0121 [NCT00027846]</a>), immediate postoperative radiation therapy was given to all children older than 1 year after gross-total resection or near-total resection. The study
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class="pdq-content-list"><ol id="_1841"><li>A prospective multi-institutional cooperative group trial (Children's Oncology Group [COG] <a href="/clinicaltrials/NCT00027846">ACNS0121 [NCT00027846]</a>) included patients with newly diagnosed intracranial ependymomas (N = 356). Surgery alone was used for the treatment of supratentor
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"><ol id="_1841"><li>A prospective multi-institutional cooperative group trial (Children's Oncology Group [COG] <a href="/clinicaltrials/NCT00027846">ACNS0121 [NCT00027846]</a>) included patients with newly diagnosed intracranial ependymomas (N = 356). Surgery alone was used for the treatment of supratentorial, WHO grade 2, gross
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59.4 Gy to the tumor bed for children aged 3 years and older.[<a href="#cit/section_8.5">5</a>,<a href="#cit/section_8.14">14</a>] The <a href="/clinicaltrials/NCT00027846">ACNS0121 (NCT00027846)</a> study extended the use of radiation therapy (54 Gy) to patients as young as 1 year, resulting in similar EFS and OS rates when comp
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d for children aged 3 years and older.[<a href="#cit/section_8.5">5</a>,<a href="#cit/section_8.14">14</a>] The <a href="/clinicaltrials/NCT00027846">ACNS0121 (NCT00027846)</a> study extended the use of radiation therapy (54 Gy) to patients as young as 1 year, resulting in similar EFS and OS rates when compared with children olde
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="pdq-content-list"><ul id="_318"><li>The 7-year EFS rate was 76.9% (± 13.5%).</li></ul></div> </li><li>A COG prospective study (<a href="/clinicaltrials/NCT00027846">ACNS0121 [NCT00027846]</a>) enrolled 356 patients between the ages of 1 and 21 years with newly diagnosed ependymoma into four strata.[<a href="#cit/section_8
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id="_318"><li>The 7-year EFS rate was 76.9% (± 13.5%).</li></ul></div> </li><li>A COG prospective study (<a href="/clinicaltrials/NCT00027846">ACNS0121 [NCT00027846]</a>) enrolled 356 patients between the ages of 1 and 21 years with newly diagnosed ependymoma into four strata.[<a href="#cit/section_8.8">8</a>][<a href="/Co
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hose for children achieving a gross-total resection followed by radiation therapy.[<a href="#cit/section_8.28">28</a>]</li><li>The COG <a href="/clinicaltrials/NCT00027846">ACNS0121 (NCT00027846)</a> trial included two cycles of preirradiation chemotherapy for children with residual disease after up-front surgery (n = 64).[<a hre
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ving a gross-total resection followed by radiation therapy.[<a href="#cit/section_8.28">28</a>]</li><li>The COG <a href="/clinicaltrials/NCT00027846">ACNS0121 (NCT00027846)</a> trial included two cycles of preirradiation chemotherapy for children with residual disease after up-front surgery (n = 64).[<a href="#cit/section_8.8">8<
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ically, postoperative radiation therapy was omitted for children younger than 3 years with ependymomas. Two COG studies (POG-9233 and <a href="/clinicaltrials/NCT00027846">ACNS0121 [NCT00027846]</a>) and many subsequent trials have lowered the age limit for postoperative radiation therapy to 1 year in an effort to improve outcom
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adiation therapy was omitted for children younger than 3 years with ependymomas. Two COG studies (POG-9233 and <a href="/clinicaltrials/NCT00027846">ACNS0121 [NCT00027846]</a>) and many subsequent trials have lowered the age limit for postoperative radiation therapy to 1 year in an effort to improve outcomes for these younger ch
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Childhood Ependymoma Treatment (PDQ®)–Health Professional Version
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context
Updated: January 6, 2025
datetime
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January 6, 2025
source url
https://www.cancer.gov/types/brain/hp/child-ependymoma-treatment-pdq

Preserved source evidence · Not medical advice