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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00027846
First received: December 7, 2001
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Brain Tumor
Central Nervous System Tumor
 Biological: filgrastim
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: vincristine sulfate
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Procedure: quality of life assessment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients With Localized Ependymoma, Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma and Observation for Completely Resected, Differentiated, Supratentorial Ependymoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival, defined as time to disease progression, disease relapse, occurrence of second neoplasm, or death from any cause [ Time Frame: Up to 5 years after completion of study treatment ] [ Designated as safety issue: No ]
    Analyzed by standard survival methods, including stratified and unstratified logrank tests and Cox regression analysis for assessing the association between outcome and patient and tumor characteristics, and the product-limit (Kaplan-Meier) estimate for estimation of EFS probability.


Secondary Outcome Measures:
  • Overall survival, defined as time to death [ Time Frame: Up to 5 years after completion of study treatment ] [ Designated as safety issue: No ]
    Analyzed by standard survival methods, including stratified and unstratified logrank tests and Cox regression analysis for assessing the association between outcome and patient and tumor characteristics, and the product-limit (Kaplan-Meier) estimate for estimation of OS probability.

  • Rate of gross-total or near-total resection and second surgery after chemotherapy [ Time Frame: At the time of second surgery ] [ Designated as safety issue: No ]
  • EFS between centrally reviewed differentiated ependymoma and anaplastic ependymoma under prescribed treatment strategy [ Time Frame: Up to 5 years after completion of study treatment ] [ Designated as safety issue: No ]
    This analysis will be based on a log-rank comparison of EFS estimates in these two groups.

  • Local control and patterns of failure [ Time Frame: Up to 5 years after completion of study treatment ] [ Designated as safety issue: No ]
    Documented and analyzed qualitatively and quantitatively.

  • Influence of histologic grade on the time to progression [ Time Frame: Up to 5 years after completion of study treatment ] [ Designated as safety issue: No ]

Enrollment: 378
Study Start Date: August 2003
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group 1
Patients undergo observation.
Experimental: Group 2
Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.
 Radiation: radiation therapy
Given once daily 5 days a week for 6-6½ weeks
Other Name: irradiation, radiotherapy, therapy, radiation
Procedure: quality of life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Group 3
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.
 Biological: filgrastim
Given subcutaneously or IV
Other Name: G CSF, G-CSF, G-CSF, granulocyte colony stimulating factor, granulocyte colony-stimulating factor
Drug: carboplatin
Given IV or orally
Other Name: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA,
Drug: cyclophosphamide
Given IV or orally
Other Name: Neosar, Procytox, Sendoxan, Syklofosfamid, WR-138719, Zytoxan
Drug: etoposide
Given IV or orally
Other Name: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, epipodophyllotoxin, Lastet, Toposar, VePesid
Drug: vincristine sulfate
Given IV or orally
Other Name: 22-oxovincaleukoblastine, 57-22-7, leurocristine sulfate, VCR, Vincasar PFS
Procedure: therapeutic conventional surgery
Patients who have resectable disease undergo second surgery.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027846

  Show 165 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Thomas E. Merchant, DO, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00027846     History of Changes
Other Study ID Numbers: ACNS0121, CDR0000069086, NCI-2012-02431, COG-ACNS0121
Study First Received: December 7, 2001
Last Updated: May 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
childhood infratentorial ependymoma

Additional relevant MeSH terms:
Brain Neoplasms
Ependymoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Cyclophosphamide
Etoposide phosphate
Etoposide
Podophyllotoxin
Vincristine
Carboplatin
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on May 23, 2013