- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00085735
Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. Compare event-free survival (EFS) of pediatric patients (3 to 7 years of age) with newly diagnosed standard-risk medulloblastoma treated with standard-dose versus (vs.) reduced-dose craniospinal radiotherapy (SDCSI vs. LDCSI).
II. Compare EFS of patients (3-21 years of age) treated with standard-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with this chemotherapy regimen.
SECONDARY OBJECTIVES:
I. Compare overall survival (OS) of pediatric patients (3-7 years of age) with newly diagnosed standard-risk medulloblastoma treated with SDCSI vs. LDCSI.
II. Compare OS of patients (3-21 years of age) with newly diagnosed standard-risk medulloblastoma treated with PFRT vs. IFRT.
III. To evaluate patterns of failure in patients treated with an irradiation boost volume smaller than conventional posterior fossa volumes.
IV. To reduce the cognitive, auditory, and endocrinologic effects of treatment of average-risk medulloblastoma by reducing the dose of craniospinal irradiation therapy.
V. To determine if the audiologic and endocrinologic toxicity will be reduced with the use of limited tumor boost volume irradiation compared to patients treated with conventional target volumes of radiation.
VI. Develop an optimal gene expression medulloblastoma outcome predictor, validated prospectively in a multi-institution randomized clinical trial.
VII. To improve compliance with long-term quality of life (QoL) and functional status data submission by educating institutional nurses to administer and submit for analysis a battery of four instruments (Behavior Assessment System for Children- 2nd Edition (BASC-2), Adaptive Behavior Assessment System - 2nd Edition (ABAS-II), Behavior Rating Inventory of Executive Function (BRIEF) and PedsQLTM 4.0).
OUTLINE: Patients 3-7 years of age are randomized to 1 of 4 arms (Arm I-IV). Patients 8-21 years of age are randomized to 1 of 2 arms (Arm V or VI).
Within 31 days after definitive surgery, all patients begin therapy. Patients undergo radiation therapy with doses according to their Arm randomization on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). All patients receive vincristine intravenously (IV) over 1 minute (or infusion via minibag as per institutional policy) on days 8, 15, 22, 29, 36, and 43 (weeks 1-6).
ARM I: Patients 3-7 years of age undergo lowered dose craniospinal irradiation (LDCSI) with involved-field radiation therapy (IFRT) boost.
ARM II: Patients 3-7 years of age undergo LDCSI with whole posterior fossa radiation therapy (PFRT) boost.
ARM III: Patients 3-7 years of age undergo standard dose craniospinal irradiation (SDCSI) with IFRT boost.
ARM IV: Patients 3-7 years of age undergo SDCSI with PFRT boost.
ARM V: Patients 8-21 years of age undergo SDCSI with IFRT boost.
ARM VI: Patients 8-21 years of age undergo SDCSI with PFRT boost.
MAINTENANCE CHEMOTHERAPY: Beginning 4 weeks after completion of chemoradiotherapy, patients receive 2 different regimens of maintenance chemotherapy for a total of 9 courses. Each course in regimen A is 6 weeks (42 days) in duration. Each course in regimen B is 4 weeks (28 days) in duration.
REGIMEN A (courses 1, 2, 4, 5, 7, and 8): Patients receive lomustine orally and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49.
REGIMEN B (courses 3, 6, and 9): Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23, 39, and 55.
Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry. Neurocognitive function may also be assessed.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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South Australia
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North Adelaide, South Australia, Australia, 5006
- Women's and Children's Hospital-Adelaide
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Western Australia
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Perth, Western Australia, Australia, 6008
- Princess Margaret Hospital for Children
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Quebec, Canada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Child Health Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Hamilton, Ontario, Canada, L8S 4L8
- Chedoke Hospital at Hamilton Health Sciences
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London, Ontario, Canada, N6A 5W9
- Children's Hospital
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- The Montreal Children's Hospital of the MUHC
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Montreal, Quebec, Canada, H3T 1C5
- Centre Hospitalier Universitaire Sainte-Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Den Haag, Netherlands, 2504 AM
- Dutch Childhood Oncology Group
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Christchurch, New Zealand, 8011
- Christchurch Hospital
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Auckland
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Grafton, Auckland, New Zealand, 1145
- Starship Children's Hospital
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Bern, Switzerland, 3010
- Swiss Pediatric Oncology Group - Bern
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Geneva, Switzerland, 1205
- Swiss Pediatric Oncology Group - Geneva
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Lausanne, Switzerland, 1011
- Swiss Pediatric Oncology Group - Lausanne
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Alabama
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Birmingham, Alabama, United States, 35233
- Children's Hospital of Alabama
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Arizona
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Phoenix, Arizona, United States, 85016
- Phoenix Childrens Hospital
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Tucson, Arizona, United States, 85724
- The University of Arizona Medical Center-University Campus
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California
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Downey, California, United States, 90242
- Southern California Permanente Medical Group
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Long Beach, California, United States, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Madera, California, United States, 93636-8762
- Children's Hospital Central California
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Oakland, California, United States, 94611
- Kaiser Permanente-Oakland
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Oakland, California, United States, 94609-1809
- Children's Hospital and Research Center at Oakland
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Orange, California, United States, 92868
- Children's Hospital of Orange County
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Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital Stanford University
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Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
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Sacramento, California, United States, 95816
- Sutter General Hospital
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San Diego, California, United States, 92123
- Rady Children's Hospital - San Diego
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Santa Barbara, California, United States, 93102
- Santa Barbara Cottage Hospital
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, United States, 06520
- Yale University
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Delaware
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Wilmington, Delaware, United States, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Washington, District of Columbia, United States, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward Health Medical Center
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Fort Myers, Florida, United States, 33908
- Golisano Children's Hospital of Southwest Florida
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Hollywood, Florida, United States, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, United States, 33155
- Nicklaus Children's Hospital
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Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Orlando, Florida, United States, 32803
- Florida Hospital Orlando
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Orlando, Florida, United States, 32827
- Nemours Children's Hospital
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Pensacola, Florida, United States, 32504
- Nemours Children's Clinic - Pensacola
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Saint Petersburg, Florida, United States, 33701
- All Children's Hospital
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Tampa, Florida, United States, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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West Palm Beach, Florida, United States, 33407
- Saint Mary's Hospital
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta - Egleston
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Augusta, Georgia, United States, 30912
- Georgia Regents University Medical Center
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Savannah, Georgia, United States, 31404
- Memorial University Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96859
- Tripler Army Medical Center
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Idaho
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Boise, Idaho, United States, 83712
- Saint Luke's Mountain States Tumor Institute
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, United States, 60612
- University of Illinois
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Chicago, Illinois, United States, 60611
- Lurie Children's Hospital-Chicago
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Oak Lawn, Illinois, United States, 60453
- Advocate Children's Hospital-Oak Lawn
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Peoria, Illinois, United States, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, United States, 46260
- Saint Vincent Hospital and Health Care Center
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Iowa
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Des Moines, Iowa, United States, 50309
- Blank Children's Hospital
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Iowa City, Iowa, United States, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, United States, 40202
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University Health Sciences Center
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New Orleans, Louisiana, United States, 70118
- Children's Hospital New Orleans
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Maine
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Bangor, Maine, United States, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, United States, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, United States, 21201
- University of Maryland/Greenebaum Cancer Center
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Bethesda, Maryland, United States, 20889-5600
- Walter Reed National Military Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, United States, 02111
- Floating Hospital for Children at Tufts Medical Center
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Boston, Massachusetts, United States, 02115
- Dana-Farber/Harvard Cancer Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- C S Mott Children's Hospital
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Detroit, Michigan, United States, 48236
- Saint John Hospital and Medical Center
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Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
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East Lansing, Michigan, United States, 48824-7016
- Michigan State University Clinical Center
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Flint, Michigan, United States, 48502
- Hurley Medical Center
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Grand Rapids, Michigan, United States, 49503
- Helen DeVos Children's Hospital at Spectrum Health
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Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, United States, 49008
- Kalamazoo Center for Medical Studies
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Saint Paul, Minnesota, United States, 55102
- Children's Hospital and Clinic-Saint Paul
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, United States, 64108
- The Childrens Mercy Hospital
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, United States, 63104
- Cardinal Glennon Children's Medical Center
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Nebraska
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Omaha, Nebraska, United States, 68114
- Children's Hospital and Medical Center of Omaha
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Nevada
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Las Vegas, Nevada, United States, 89106
- Nevada Cancer Research Foundation CCOP
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Morristown, New Jersey, United States, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, United States, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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Newark, New Jersey, United States, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, United States, 07503
- Saint Joseph's Regional Medical Center
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Summit, New Jersey, United States, 07902
- Overlook Hospital
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- University of New Mexico Cancer Center
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New York
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Albany, New York, United States, 12208
- Albany Medical Center
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Bronx, New York, United States, 10467-2490
- Montefiore Medical Center - Moses Campus
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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Mineola, New York, United States, 11501
- Winthrop University Hospital
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New Hyde Park, New York, United States, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
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New York, New York, United States, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
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New York, New York, United States, 10032
- Columbia University/Herbert Irving Cancer Center
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Rochester, New York, United States, 14642
- University of Rochester
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Syracuse, New York, United States, 13210
- State University of New York Upstate Medical University
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Valhalla, New York, United States, 10595
- New York Medical College
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
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Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte, North Carolina, United States, 28204
- Novant Health Presbyterian Medical Center
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Greenville, North Carolina, United States, 27858
- East Carolina University
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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North Dakota
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Fargo, North Dakota, United States, 58122
- Sanford Medical Center-Fargo
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Ohio
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Akron, Ohio, United States, 44308
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Dayton, Ohio, United States, 45404
- Dayton Children's Hospital
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Toledo, Ohio, United States, 43606
- The Toledo Hospital/Toledo Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Portland, Oregon, United States, 97227
- Legacy Emanuel Children's Hospital
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Portland, Oregon, United States, 97227
- Legacy Emanuel Hospital and Health Center
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18017
- Lehigh Valley Hospital - Muhlenberg
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Children's Hospital
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Philadelphia, Pennsylvania, United States, 19134
- Saint Christopher's Hospital for Children
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Columbia, South Carolina, United States, 29203
- Palmetto Health Richland
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Greenville, South Carolina, United States, 29605
- BI-LO Charities Children's Cancer Center
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Greenville, South Carolina, United States, 29605
- Greenville Cancer Treatment Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- T C Thompson Children's Hospital
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Knoxville, Tennessee, United States, 37916
- East Tennessee Childrens Hospital
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Nashville, Tennessee, United States, 37232
- Vanderbilt University/Ingram Cancer Center
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Texas
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Amarillo, Texas, United States, 79106
- Texas Tech University Health Science Center-Amarillo
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Austin, Texas, United States, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, United States, 78411
- Driscoll Children's Hospital
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Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, United States, 75230
- Medical City Dallas Hospital
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Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
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Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Lubbock, Texas, United States, 79410
- Covenant Children's Hospital
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States, 78229
- Methodist Children's Hospital of South Texas
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Temple, Texas, United States, 76508
- Scott and White Memorial Hospital
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Utah
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Salt Lake City, Utah, United States, 84113
- Primary Children's Hospital
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Vermont
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Burlington, Vermont, United States, 05405
- University of Vermont College of Medicine
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Virginia
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Falls Church, Virginia, United States, 22042
- Inova Fairfax Hospital
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Norfolk, Virginia, United States, 23507
- Childrens Hospital-King's Daughters
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Portsmouth, Virginia, United States, 23708-2197
- Naval Medical Center - Portsmouth
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Roanoke, Virginia, United States, 24014
- Carilion Clinic Children's Hospital
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Spokane, Washington, United States, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
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Tacoma, Washington, United States, 98431
- Madigan Army Medical Center
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West Virginia
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Charleston, West Virginia, United States, 25304
- West Virginia University Charleston
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- Saint Vincent Hospital
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic
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Milwaukee, Wisconsin, United States, 53226
- Midwest Children's Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (3-7 years of age, LDCSI, IFRT)
See Detailed Description (Arm I)
|
Correlative studies
Ancillary studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo craniospinal Irradiation
Undergo smaller volume boost (involved-field radiation therapy)
Other Names:
Given orally
Other Names:
|
Experimental: Arm II (3-7 years of age, LDCSI, PFRT)
See Detailed Description (Arm II)
|
Correlative studies
Ancillary studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo craniospinal Irradiation
Given orally
Other Names:
Undergo standard volume boost (whole posterior fossa radiation therapy)
Other Names:
|
Experimental: Arm III (3-7 years of age, SDCSI, IFRT)
See Detailed Description (Arm III)
|
Correlative studies
Ancillary studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo craniospinal Irradiation
Undergo smaller volume boost (involved-field radiation therapy)
Other Names:
Given orally
Other Names:
|
Active Comparator: Arm IV (3-7 years of age, SDCSI, PFRT)
See Detailed Description (Arm IV)
|
Correlative studies
Ancillary studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo craniospinal Irradiation
Given orally
Other Names:
Undergo standard volume boost (whole posterior fossa radiation therapy)
Other Names:
|
Experimental: Arm V (8-21 years of age, SDCSI, IFRT)
See Detailed Description (Arm V)
|
Correlative studies
Ancillary studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo craniospinal Irradiation
Undergo smaller volume boost (involved-field radiation therapy)
Other Names:
Given orally
Other Names:
|
Active Comparator: Arm VI (8-21 years of age, SDCSI, PFRT)
See Detailed Description (Arm VI)
|
Correlative studies
Ancillary studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Undergo craniospinal Irradiation
Given orally
Other Names:
Undergo standard volume boost (whole posterior fossa radiation therapy)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free Survival (EFS)
Time Frame: Assessed at 3 years
|
EFS was defined as the time interval from date of study entry to date of disease progression, disease recurrence, second malignant neoplasm or death from any cause, whichever occurs first, or to the date of last follow-up for patients without events.
EFS was estimated using the method of Kaplan and Meier.
3-year estimates are reported with 95% confidence intervals (CI's).
|
Assessed at 3 years
|
Overall Survival (OS)
Time Frame: 3 years
|
OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors.
OS was estimated using the method of Kaplan and Meier.
3-year estimates are reported with 95% CI's.
For purposes of this analysis, arms I, III and V (involved field radiation therapy [IFRT]) are combined and compared to arms II, IV and VI (posterior fossa irradiation [PFRT]).
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local Posterior Fossa (LPF) Failure Rate
Time Frame: 3 years
|
LPF failure was defined as tumor recurrence/progression within the tumor bed.
The cumulative incidence (CI) of LPF failure was estimated; 3-year estimates were reported with 95% confidence intervals.
Patients with other failure types (e.g., NPF) and with other events prior to LPF failure (e.g., death, second malignancy) were considered as having competing events.
|
3 years
|
Non-local Posterior Fossa (NLPF) Failure Rate
Time Frame: 3 years
|
NLPF failure was defined as tumor recurrence/progression outside the radiation therapy clinical target volume boost (CTV-boost) but within the posterior fossa CTV (CTV-PF).
The cumulative incidence (CI) of NLPF failure was estimated; 3-year estimates were reported with 95% confidence intervals.
Patients with other failure types (e.g., NPF, LPF) and with other events prior to NLPF failure (e.g., death, second malignancy) were considered as having competing events.
|
3 years
|
Non-posterior Fossa (NPF) Failure Rate
Time Frame: 3 years
|
NPF failure was defined as tumor recurrence within the neuroaxis but outside the radiation therapy clinical target volume (CTV).
The cumulative incidence (CI) of NPF failure was estimated; 3-year estimates were reported with 95% confidence intervals.
Patients with other failure types (e.g., LPF failure) and with other events prior to NPF failure (e.g., death, second malignancy) were considered as having competing events.
|
3 years
|
Post-treatment Endocrine Function by CSI Group
Time Frame: Up to 3 years
|
Post-treatment endocrine function was measured by laboratory assessment of the thyroid stimulating hormone (TSH).
The mean TSH will be reported.
|
Up to 3 years
|
Post-treatment Grade 3+ Hearing Loss as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4
Time Frame: Up to 3 years
|
Proportions of patients with grade 3+ hearing loss after the completion of therapy will be calculated and reported separately for low dose craniospinal irradiation (LDCSI) versus (vs.) standard dose craniospinal irradiation (SDCSI) patients.
Eligible and evaluable patients 3-7 years of age will be used.
|
Up to 3 years
|
Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 1 (4 - 15 Months Post Diagnosis).
Time Frame: 4 -15 months post diagnosis
|
Post-treatment neurocognitive function was assessed.
Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function.
FSIQ was measured by IQ tests.
Assessments within the time window, from eligible and evaluable patients are reported.
The time window is 4-15 months post diagnosis, only the assessments before progression date were reported.
The Range of FSIQ is 50-150.
A higher FSIQ is better.
|
4 -15 months post diagnosis
|
Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 2 (27 - 48 Months Post Diagnosis)
Time Frame: 27 - 48 months post diagnosis
|
Post-treatment neurocognitive function was assessed.
Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function.
FSIQ was measured by IQ tests.
Assessments within the time window, from eligible and evaluable patients are reported.
The time window is 27-48 months post diagnosis, only the assessments before progression date were reported.
The range of FSIQ is 50 - 150.
A higher FSIQ is better.
|
27 - 48 months post diagnosis
|
Post-treatment Neurocognitive Function as Measured by the Estimated Full-scale IQ (FSIQ) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
Time Frame: 49 - 72 months post diagnosis
|
Post-treatment neurocognitive function was assessed.
Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function.
FSIQ was measured by IQ tests.
Assessments within the time window, from eligible and evaluable patients are reported.
The time window is 49-72 months post diagnosis, only the assessments before progression date were reported.
The Range of FSIQ is 50-150.
A higher FSIQ is better.
|
49 - 72 months post diagnosis
|
Incidence of Grade 3+ Hearing Loss at 1-year Post Treatment as Assessed by CTCAE v4
Time Frame: Up to 3 years
|
Proportions of patients with grade 3+ hearing impairment as assessed by CTCAE v4 at 1-year post treatment were calculated.
|
Up to 3 years
|
Incidence of Endocrine Dysfunction as Measured by Growth Hormone Stimulation Tests at the Time of Completion of Therapy by Radiotherapy (RT) Group
Time Frame: Post-treatment up to 3 years
|
Endocrine dysfunction was assessed by growth hormone stimulation (GHS) tests.
We report the percentage of patients with abnormal growth hormone stimulation tests.
|
Post-treatment up to 3 years
|
Overall Survival (OS) by Molecular Subgroup Based on Methylation Arrays
Time Frame: 3 years
|
OS was defined as the time interval from date of study entry to date of death from any cause or to date of last contact for survivors.
OS was estimated using the method of Kaplan and Meier.
3-year estimates are reported with 95% CI's.
|
3 years
|
Progression-free Survival (PFS) by Molecular Subgroup Based on Methylation Arrays
Time Frame: 3 years
|
PFS was defined as the time interval from date of study entry to disease progression, relapse or death due to cancer or to last follow-up.
Second malignancies and deaths from causes clearly not associated with tumor progression or recurrence were censored.
PFS was estimated using the method of Kaplan and Meier.
3-year estimates are reported with 95% CI's.
|
3 years
|
Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 1 (4-15 Months Post Diagnosis)
Time Frame: 4 - 15 months post diagnosis
|
Metacognition index (MI) was measured by BRIEF test.
Assessments within the time window, from eligible and evaluable patients are reported.
If the patient had disease progression, only the assessments before progression date were reported.
The MI is a standard T- score, and it ranges from 0 to 100.
The higher score reported suggests a higher level of dysfunction.
|
4 - 15 months post diagnosis
|
Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 2 (27-48 Months Post Diagnosis)
Time Frame: 27-48 months post diagnosis
|
Metacognition index (MI) was measured by BRIEF test.
Assessments within the time window, from eligible and evaluable patients are reported.
If the patient had disease progression, only the assessments before progression date were reported.
The MI is a standard T- score, and it ranges from 0 to 100.
The higher score reported suggests a higher level of dysfunction.
|
27-48 months post diagnosis
|
Post-treatment Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) by CSI Group Within Time Window 3 (49 - 72 Months Post Diagnosis)
Time Frame: 49 - 72 months post diagnosis
|
Metacognition index (MI) was measured by BRIEF test.
Assessments within the time window, from eligible and evaluable patients are reported.
If the patient had disease progression, only the assessments before progression date were reported.
The MI is a standard T- score, and it ranges from 0 to 100.
The higher score reported suggests a higher level of dysfunction.
|
49 - 72 months post diagnosis
|
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 1 (4-15 Months Post Diagnosis)
Time Frame: 4-15 months post diagnosis
|
Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission.
A patient will be compliant if the patient has metacognition index score.
Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows.
All eligible and evaluable patients enrolled will be used.
Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.
The time window is 4 - 15 months post diagnosis.
|
4-15 months post diagnosis
|
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 2 (27-48 Months Post Diagnosis)
Time Frame: 27-48 months post diagnosis
|
Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission.
A patient will be compliant if the patient has metacognition index score.
Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows.
All eligible and evaluable patients enrolled will be used.
Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.
The time window is 27 - 48 months post diagnosis.
|
27-48 months post diagnosis
|
Compliance Rates for All Eligible and Evaluable Patients Enrolled Within Time Window 3 (49 - 72 Months Post Diagnosis)
Time Frame: 49 - 72 months post diagnosis
|
Compliance rates are calculated to monitor the compliance with long-term quality of life and functional status data submission.
A patient will be compliant if the patient has metacognition index score.
Compliance rates will be assessed at each of the 3 neurocognitive/quality of life assessment time windows.
All eligible and evaluable patients enrolled will be used.
Patients removed from treatment prior to the time of neuropsychological assessment (for reasons such as disease progression, death, withdrawal of consent, etc.) will not be included in the denominator to assess the compliance rate.
The time window is 49 - 72 months post diagnosis.
|
49 - 72 months post diagnosis
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeff Michalski, Children's Oncology Group
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive
- Medulloblastoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Cyclophosphamide
- Cisplatin
- Vincristine
- Lomustine
Other Study ID Numbers
- ACNS0331 (Other Identifier: CTEP)
- U10CA098543 (U.S. NIH Grant/Contract)
- NCI-2009-00335 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- COG-ACNS0331
- CDR0000365506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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