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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

Phase 2
1 Year
21 Years
Not Enrolling
Brain Tumor, Central Nervous System Tumor

Thank you

Trial Information

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


- 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

- 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

- 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

Inclusion Criteria


- 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



- 1 to 21

Performance status:

- No restrictions

Life expectancy:

- At least 2 months


- Not specified


- Not specified


- Not specified


- Able to undergo MRI

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Prior or concurrent corticosteroids allowed


- No prior radiotherapy


- See Disease Characteristics

- More than 1 prior surgery allowed


- No other prior treatment for ependymoma

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Up to 5 years after completion of study treatment

Safety Issue:


Principal Investigator

Thomas E. Merchant, DO, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Federal Government

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Brain Tumor
  • Central Nervous System Tumor
  • childhood supratentorial ependymoma
  • newly diagnosed childhood ependymoma
  • childhood infratentorial ependymoma
  • Brain Neoplasms
  • Ependymoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
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Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Hurley Medical Center Flint, Michigan  48503
Medical City Dallas Hospital Dallas, Texas  75230
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CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington, Connecticut  06360-2875
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Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Sutter Cancer Center Sacramento, California  95816
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
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Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
All Children's Hospital St. Petersburg, Florida  33701
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Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
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Schneider Children's Hospital New Hyde Park, New York  11042
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Driscoll Children's Hospital Corpus Christi, Texas  78466
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
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Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Southern California Permanente Medical Group Downey, California  90242
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Southern Illinois University School of Medicine Springfield, Illinois  62794-9658
Kosair Children's Hospital Louisville, Kentucky  40202-3830
Sunrise Hospital and Medical Center Las Vegas, Nevada  89109-2306
Children's Hospital Medical Center of Akron Akron, Ohio  44308
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East Tennessee Children's Hospital Knoxville, Tennessee  37901
Children's Hospital of Austin Austin, Texas  78701
Covenant Children's Hospital Lubbock, Texas  79410
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
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Children's Hospital and Health Center - San Diego San Diego, California  92123-4282
Lee Cancer Care of Lee Memorial Health System Fort Myers, Florida  33901
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Nemours Children's Clinic - Orlando Orlando, Florida  32806
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, Florida  32803-1273
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St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa, Florida  33607
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Winship Cancer Institute of Emory University Atlanta, Georgia  30322
St. Luke's Mountain States Tumor Institute - Boise Boise, Idaho  83712-6297
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Blank Children's Hospital Des Moines, Iowa  50309
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Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Hackensack University Medical Center Cancer Center Hackensack, New Jersey  07601
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NYU Cancer Institute at New York University Medical Center New York, New York  10016
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
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Toledo Hospital Toledo, Ohio  43606
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Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Greenville Hospital System Cancer Center Greenville, South Carolina  29605
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Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Baylor University Medical Center - Houston Houston, Texas  77030-2399
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Naval Medical Center - Portsmouth Portsmouth, Virginia  23708-2197
Carilion Cancer Center of Western Virginia Roanoke, Virginia  24029
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
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St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
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Childrens Hospital Los Angeles Los Angeles, California  90027
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MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
Advocate Lutheran General Cancer Care Center Park Ridge, Illinois  60068-1174
Maine Children's Cancer Program at Barbara Bush Children's Hospital Scarborough, Maine  04074-9308
C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor, Michigan  48109-0286
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota  55404
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Tod Children's Hospital Youngstown, Ohio  44501
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