Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
Untreated Childhood Medulloblastoma
About this trial
This is an interventional treatment trial for Untreated Childhood Medulloblastoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed medulloblastoma located in the posterior fossa Standard-risk disease Minimal volume, non-disseminated disease, defined by the following: Residual tumor ≤ 1.5 cm^2 confirmed by MRI with contrast imaging within 21 days after surgery No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by both of the following: Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery Negative cytological examination of CSF after surgery, but before study enrollment Brain stem involvement allowed Performance status - Karnofsky 50-100% (> 16 years of age) Performance status - Lansky 30-100% (≤ 16 years of age) Absolute neutrophil count > 1,500/uL Platelet count > 100,000/uL (transfusion independent) Hemoglobin > 10 g/dL (transfusions allowed) Bilirubin < 1.5 times upper limit of normal (ULN) for age AST or ALT < 1.5 times ULN for age Creatinine clearance OR radioisotope glomerular filtration rate >= 70 mL/min/1.73m^2 or a serum creatinine based on age/gender as follows: Age Maximum Serum Creatine (mg/dL) 1month to < 6 months male: 0.4 female: 0.4 6 months to <1 year male: 0.5 female: 0.5 1 year to < 2 years male: 0.6 female: 0.6 2 to < 6 years male: 0.8 female: 0.8 6 to < 10 years male: 1 female: 1 10 to < 13 years male: 1.2 female: 1.2 13 to < 16 years male: 1.5 female: 1.4 >= 16 years male: 1.7 female: 1.4 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior chemotherapy Prior corticosteroids allowed No prior radiotherapy
Sites / Locations
- Children's Hospital of Alabama
- Phoenix Childrens Hospital
- The University of Arizona Medical Center-University Campus
- Southern California Permanente Medical Group
- Loma Linda University Medical Center
- Miller Children's and Women's Hospital Long Beach
- Children's Hospital Los Angeles
- Cedars-Sinai Medical Center
- Children's Hospital Central California
- Children's Hospital and Research Center at Oakland
- Kaiser Permanente-Oakland
- Children's Hospital of Orange County
- Lucile Packard Children's Hospital Stanford University
- Sutter General Hospital
- University of California Davis Comprehensive Cancer Center
- Rady Children's Hospital - San Diego
- Santa Barbara Cottage Hospital
- Children's Hospital Colorado
- Connecticut Children's Medical Center
- Yale University
- Alfred I duPont Hospital for Children
- MedStar Georgetown University Hospital
- Children's National Medical Center
- Broward Health Medical Center
- Golisano Children's Hospital of Southwest Florida
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Nemours Children's Clinic-Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Nicklaus Children's Hospital
- Florida Hospital Orlando
- Nemours Children's Hospital
- Nemours Children's Clinic - Pensacola
- All Children's Hospital
- Saint Joseph's Hospital/Children's Hospital-Tampa
- Saint Mary's Hospital
- Children's Healthcare of Atlanta - Egleston
- Georgia Regents University Medical Center
- Memorial University Medical Center
- Tripler Army Medical Center
- Saint Luke's Mountain States Tumor Institute
- Lurie Children's Hospital-Chicago
- University of Illinois
- University of Chicago Comprehensive Cancer Center
- Advocate Children's Hospital-Oak Lawn
- Saint Jude Midwest Affiliate
- Southern Illinois University School of Medicine
- Riley Hospital for Children
- Saint Vincent Hospital and Health Care Center
- Blank Children's Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- University of Kentucky/Markey Cancer Center
- Kosair Children's Hospital
- Tulane University Health Sciences Center
- Children's Hospital New Orleans
- Eastern Maine Medical Center
- Maine Children's Cancer Program
- University of Maryland/Greenebaum Cancer Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Walter Reed National Military Medical Center
- Floating Hospital for Children at Tufts Medical Center
- Massachusetts General Hospital Cancer Center
- Dana-Farber/Harvard Cancer Center
- C S Mott Children's Hospital
- Wayne State University/Karmanos Cancer Institute
- Saint John Hospital and Medical Center
- Michigan State University Clinical Center
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Bronson Methodist Hospital
- Kalamazoo Center for Medical Studies
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- University of Minnesota/Masonic Cancer Center
- Mayo Clinic
- Children's Hospital and Clinic-Saint Paul
- University of Mississippi Medical Center
- The Childrens Mercy Hospital
- Cardinal Glennon Children's Medical Center
- Washington University School of Medicine
- Children's Hospital and Medical Center of Omaha
- Nevada Cancer Research Foundation CCOP
- Dartmouth Hitchcock Medical Center
- Hackensack University Medical Center
- Morristown Medical Center
- Saint Peter's University Hospital
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Newark Beth Israel Medical Center
- Saint Joseph's Regional Medical Center
- Overlook Hospital
- University of New Mexico Cancer Center
- Albany Medical Center
- Montefiore Medical Center - Moses Campus
- Roswell Park Cancer Institute
- Winthrop University Hospital
- The Steven and Alexandra Cohen Children's Medical Center of New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Columbia University/Herbert Irving Cancer Center
- University of Rochester
- State University of New York Upstate Medical University
- New York Medical College
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- East Carolina University
- Wake Forest University Health Sciences
- Sanford Medical Center-Fargo
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Cleveland Clinic Foundation
- Nationwide Children's Hospital
- Dayton Children's Hospital
- The Toledo Hospital/Toledo Children's Hospital
- University of Oklahoma Health Sciences Center
- Legacy Emanuel Children's Hospital
- Legacy Emanuel Hospital and Health Center
- Oregon Health and Science University
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Medical Center
- Penn State Hershey Children's Hospital
- Saint Christopher's Hospital for Children
- Rhode Island Hospital
- Medical University of South Carolina
- Palmetto Health Richland
- BI-LO Charities Children's Cancer Center
- Greenville Cancer Treatment Center
- Sanford USD Medical Center - Sioux Falls
- T C Thompson Children's Hospital
- East Tennessee Childrens Hospital
- Vanderbilt University/Ingram Cancer Center
- Texas Tech University Health Science Center-Amarillo
- Dell Children's Medical Center of Central Texas
- Driscoll Children's Hospital
- Medical City Dallas Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Brooke Army Medical Center
- Cook Children's Medical Center
- M D Anderson Cancer Center
- Covenant Children's Hospital
- Methodist Children's Hospital of South Texas
- University of Texas Health Science Center at San Antonio
- Scott and White Memorial Hospital
- Primary Children's Hospital
- University of Vermont College of Medicine
- Inova Fairfax Hospital
- Childrens Hospital-King's Daughters
- Naval Medical Center - Portsmouth
- Virginia Commonwealth University/Massey Cancer Center
- Carilion Clinic Children's Hospital
- Seattle Children's Hospital
- Providence Sacred Heart Medical Center and Children's Hospital
- Madigan Army Medical Center
- West Virginia University Charleston
- Saint Vincent Hospital
- University of Wisconsin Hospital and Clinics
- Marshfield Clinic
- Midwest Children's Cancer Center
- Women's and Children's Hospital-Adelaide
- Princess Margaret Hospital for Children
- University of Alberta Hospital
- British Columbia Children's Hospital
- CancerCare Manitoba
- Janeway Child Health Centre
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Chedoke Hospital at Hamilton Health Sciences
- Children's Hospital
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- The Montreal Children's Hospital of the MUHC
- Centre Hospitalier Universitaire Sainte-Justine
- Saskatoon Cancer Centre
- Centre Hospitalier Universitaire de Quebec
- Dutch Childhood Oncology Group
- Starship Children's Hospital
- Christchurch Hospital
- Swiss Pediatric Oncology Group - Bern
- Swiss Pediatric Oncology Group - Geneva
- Swiss Pediatric Oncology Group - Lausanne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
Arm I (3-7 years of age, LDCSI, IFRT)
Arm II (3-7 years of age, LDCSI, PFRT)
Arm III (3-7 years of age, SDCSI, IFRT)
Arm IV (3-7 years of age, SDCSI, PFRT)
Arm V (8-21 years of age, SDCSI, IFRT)
Arm VI (8-21 years of age, SDCSI, PFRT)
See Detailed Description (Arm I)
See Detailed Description (Arm II)
See Detailed Description (Arm III)
See Detailed Description (Arm IV)
See Detailed Description (Arm V)
See Detailed Description (Arm VI)