Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	1 to 21	NCI	COG-ACNS0121 NCT00027846, ACNS0121

Objectives

1. Determine the local control and pattern of failure in children with completely resected, differentiated, supratentorial localized ependymoma after initial surgical resection alone.
2. Determine the rate of complete resection with second surgery after chemotherapy in patients with initially incompletely resected localized ependymoma.
3. Determine the local control and pattern of failure in patients treated with conformal radiotherapy.
4. Determine the influence of histologic grade on the time to progression in patients after treatment with conformal radiotherapy.

Entry 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

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

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

Expected Enrollment

A total of 250-350 patients will be accrued for this study within 5 years.

Outcomes

Event-free survival, defined as time to disease progression, disease relapse, occurrence of second neoplasm, or death from any cause at 2 and 5 years

Overall survival, defined as time to death at 2 and 5 years

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Thomas Merchant, DO, PhD, Protocol chair		Ph: 901-595-3604 Email: thomas.merchant@stjude.org

Registry Information
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
Trial Start Date		2003-08-25
Trial Completion Date		2008-10-12 (estimated)
Registered in ClinicalTrials.gov		NCT00027846
Date Submitted to PDQ		2001-10-16
Information Last Verified		2008-10-27
NCI Grant/Contract Number		CA13539

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