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

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00027846

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 and Central Nervous System Tumors	Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: observation Procedure: therapeutic conventional surgery Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Surgery

Drug Information available for: Cyclophosphamide Vincristine Etoposide Carboplatin Etoposide phosphate Filgrastim Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival, defined as time to death at 2 and 5 years [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	August 2003
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: No Intervention Patients undergo observation.	Procedure: observation Patients undergo observation.
Group 2: Experimental Patients undergo conformal radiotherapy 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
Group 3: Experimental 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.	Biological: filgrastim Given subcutaneously or IV Drug: carboplatin Given IV or orally Drug: cyclophosphamide Given IV or orally Drug: etoposide Given IV or orally Drug: vincristine sulfate Given IV or orally 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 - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers:	CDR0000069086, COG-ACNS0121
Study First Received:	December 7, 2001
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00027846 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
childhood infratentorial ependymoma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Central Nervous System Neoplasms
Cyclophosphamide
Ependymoma
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Glioma
Etoposide
Alkylating Agents
Nervous System Neoplasms

Neoplasms by Histologic Type
Mitosis Modulators
Nervous System Diseases
Vincristine
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 22, 2009