Spots Global Cancer Trial Database for Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
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Trial Identification
Brief Title: Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma
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
Study ID: NCT00027846
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.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Southern California Permanente Medical Group, Downey, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, United States
Childrens Hospital Los Angeles, Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, United States
Children's Hospital Central California, Madera, California, United States
Children's Hospital & Research Center Oakland, Oakland, California, United States
Children's Hospital of Orange County, Orange, California, United States
Sutter Cancer Center, Sacramento, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Kaiser Permanente Medical Center - Oakland, Sacramento, California, United States
Children's Hospital and Health Center - San Diego, San Diego, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Stanford Comprehensive Cancer Center - Stanford, Stanford, California, United States
Children's Hospital Cancer Center, Denver, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, United States
Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Miami Children's Hospital, Miami, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, United States
Nemours Children's Clinic - Orlando, Orlando, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, United States
All Children's Hospital, Saint Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
St. Luke's Mountain States Tumor Institute - Boise, Boise, Idaho, United States
Rush University Medical Center, Chicago, Illinois, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Advocate Christ Medical Center, Oak Lawn, Illinois, United States
Advocate Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
Blank Children's Hospital, Des Moines, Iowa, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, United States
Maine Children's Cancer Program at Barbara Bush Children's Hospital, Scarborough, Maine, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Spectrum Health Hospital - Butterworth Campus, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Children's Hospital, Omaha, Nebraska, United States
Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States
Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States
Overlook Hospital, Morristown, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
Albany Medical Center Hospital, Albany, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Schneider Children's Hospital, New Hyde Park, New York, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
Memorial Sloan - Kettering Cancer Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
New York Medical College, Valhalla, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
Children's Hospital Medical Center of Akron, Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Columbus Children's Hospital, Columbus, Ohio, United States
Children's Medical Center - Dayton, Dayton, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
Tod Children's Hospital, Youngstown, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
Greenville Hospital System Cancer Center, Greenville, South Carolina, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
T.C. Thompson Children's Hospital, Chattanooga, Tennessee, United States
East Tennessee Children's Hospital, Knoxville, Tennessee, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo, Texas, United States
Children's Hospital of Austin, Austin, Texas, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
Baylor University Medical Center - Houston, Houston, Texas, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Covenant Children's Hospital, Lubbock, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
INOVA Fairfax Hospital, Falls Church, Virginia, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
Carilion Cancer Center of Western Virginia, Roanoke, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
John Hunter Hospital, Newcastle, New South Wales, Australia
Prince of Wales Private Hospital, Randwick, New South Wales, Australia
Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales, Australia
Royal Children's Hospital, Herston, Brisbane, Queensland, Australia
Women's and Children's Hospital, North Adelaide, South Australia, Australia
Royal Children's Hospital, Parkville, Victoria, Australia
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
Children's Hospital of Western Ontario, London, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec, Quebec, , Canada
University Medical Center Groningen, Groningen, , Netherlands
Starship Children's Health, Auckland, , New Zealand
Swiss Pediatric Oncology Group Bern, Bern, , Switzerland
Swiss Pediatric Oncology Group Geneva, Geneva, , Switzerland
Swiss Pediatric Oncology Group Lausanne, Lausanne, , Switzerland
Contact Details
Name: Thomas E. Merchant, DO, PhD
Affiliation: St. Jude Children's Research Hospital
Role: STUDY_CHAIR
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