Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00085735
First received: June 14, 2004
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy combined with chemotherapy after surgery is more effective than reduced-dose craniospinal (head and spine) radiation therapy plus either posterior fossa (back of the brain) boost or tumor bed (site of the tumor) boost radiation therapy combined with chemotherapy in treating medulloblastoma.

PURPOSE: This randomized phase III trial is studying standard-dose radiation therapy to see how well it works compared to reduced-dose craniospinal radiation therapy AND posterior fossa boost radiation therapy to see how well it works compared to tumor bed boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma.


Condition Intervention Phase
Brain Tumor
Central Nervous System Tumor
Drug: cisplatin
Drug: cyclophosphamide
Drug: lomustine
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival (EFS) [ Time Frame: Time from study entry to disease progression, disease recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 2 years after the last enrollment ] [ Designated as safety issue: No ]
    Time-to-event for radiation therapy question will be based on logrank test. Interim monitoring for each study question will be based on the Lan-Demets criterion, with spending function αt. The time point for 100% information is defined as two years after the last patient has been enrolled.


Secondary Outcome Measures:
  • Time to recurrence, progression, or death due to cancer [ Time Frame: 2 years after the last enrollment ] [ Designated as safety issue: No ]
    Used to compute progression-free survival (PFS) rate. Death from causes that are clearly not associated with tumor recurrence or progression will be censored in this analysis

  • Time to death from any cause [ Time Frame: 2 years after the last enrollment ] [ Designated as safety issue: No ]
    Used to compute survival (S) rate.

  • Local posterior fossa (LPF) failure [ Time Frame: 2 years after the last enrollment ] [ Designated as safety issue: No ]
    LPF failure is defined as tumor recurrence or progression within the tumor bed; i.e., within clinical target volume (CTV)boost for patients randomized to tumor-bed-only (involved field) boost (or within a theoretical CTVboost for patients randomized to standard PF radiation therapy). Recurrent tumors that straddle the boundary of CTVboost will be classified as LPF if more than 50% of the tumor volume is within CTVboost.

  • Non-local posterior fossa (NLPF) failure [ Time Frame: 2 years after the last enrollment ] [ Designated as safety issue: No ]
    NLPF failure is defined as tumor outside CTVboost, but within CTVPF. Recurrent tumors that straddle the boundary of CTVboost will be classified as non-local posterior fossa (NLPF) if more than 50% of the tumor volume is outside of CTVboost. Recurrent tumors that straddle the boundary of CTVPF will be classified as LPF if more than 50% of the tumor volume is within CTVPF

  • Non-posterior fossa (NPF) failure [ Time Frame: 2 years after the last enrollment ] [ Designated as safety issue: No ]
    NPF is defined as tumor recurrence within the neuroaxis but outside of CTVPF. Recurrent tumors that straddle the boundary of CTVPF will be classified as NPF if more than 50% of the tumor volume is outside of CTVPF.

  • Post-treatment neurocognitive function as measured by neuropsychometric battery [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The analysis of toxicity and morbidity will compare the rates of adverse consequences of radiation therapy between treatment groups. The power of these comparisons can be demonstrated by reference to a two-sample test of means of normal random variables.

  • Post-treatment hearing loss as measure by audiogram or brainstem auditory evoked response (BAER) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    The analysis of toxicity and morbidity will compare the rates of adverse consequences of radiation therapy between treatment groups. The power of these comparisons can be demonstrated by reference to a two-sample test of means of normal random variables.

  • Post-treatment endocrine function (e.g., growth, sexual maturation, and need for hormone replacement) by laboratory assessment, clinical history, and exam [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The analysis of toxicity and morbidity will compare the rates of adverse consequences of radiation therapy between treatment groups. The power of these comparisons can be demonstrated by reference to a two-sample test of means of normal random variables.

  • Quality of Life as measured by Pediatric Quality of Life Inventory (PedsQL), Behavior Assessment System for Children (BASC), Behavior Rating Inventory of Executive Function (BRIEF), and Adaptive Behavior Assessment System (ABAS) at 3 years [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Incidence of grade 3 and grade 4 toxicities in any body system as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 [ Time Frame: At baseline, during and after completion of study treatment ] [ Designated as safety issue: Yes ]

Enrollment: 549
Study Start Date: April 2004
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (reduced craniospinal XRT, XRT tumor bed & Regimen A)
Patients undergo reduced-dose craniospinal radiation therapy with boost. Patients will undergo radiotherapy boost to the tumor bed only. Patients receive oral lomustine and cisplatin IV over 6 hours on day 1 and vincristine sulfate IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49.
Drug: cisplatin
Given IV
Other Names:
  • Cis-diamminedichloroplatinum II
  • CDDP
  • cis-DDP
  • Platinol-AQ
  • NSC #119875
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: lomustine
Given orally
Other Names:
  • Cyclohexylchloroethylnitrosourea
  • CCNU
  • CeeNU
  • NSC #79037
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
Experimental: Arm II (reduced craniospinal XRT, XRT tumor bed & Regimen B)
Patients undergo reduced-dose craniospinal radiation therapy with boost. Smaller volume boost radiation to tumor bed. Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine sulfate IV on days 1 and 8 of weeks 23, 39, and 55.
Drug: cisplatin
Given IV
Other Names:
  • Cis-diamminedichloroplatinum II
  • CDDP
  • cis-DDP
  • Platinol-AQ
  • NSC #119875
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
Experimental: Arm III (std craniospinal XRT, XRT tumor bed & Regimen A)
Patients undergo standard-dose craniospinal radiation therapy with boost. Standard volume boost (radiation to the entire posterior fossa. Patients receive oral lomustine and cisplatin IV over 6 hours on day 1 and vincristine sulfate IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49.
Drug: cisplatin
Given IV
Other Names:
  • Cis-diamminedichloroplatinum II
  • CDDP
  • cis-DDP
  • Platinol-AQ
  • NSC #119875
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: lomustine
Given orally
Other Names:
  • Cyclohexylchloroethylnitrosourea
  • CCNU
  • CeeNU
  • NSC #79037
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
Experimental: Arm IV (std craniospinal XRT, XRT tumor bed & Regimen B)
Patients undergo standard-dose craniospinal radiation therapy with boost. Smaller volume boost radiation to tumor bed. Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine sulfate IV on days 1 and 8 of weeks 23, 39, and 55.
Drug: cisplatin
Given IV
Other Names:
  • Cis-diamminedichloroplatinum II
  • CDDP
  • cis-DDP
  • Platinol-AQ
  • NSC #119875
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
Experimental: Arm V (reduced craniospinal XRT, XRT fossa & Regimen A)
Patients undergo reduced-dose craniospinal radiation therapy with boost. Standard volume boost (radiation to the entire posterior fossa. Patients receive oral lomustine and cisplatin IV over 6 hours on day 1 and vincristine sulfate IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49.
Drug: cisplatin
Given IV
Other Names:
  • Cis-diamminedichloroplatinum II
  • CDDP
  • cis-DDP
  • Platinol-AQ
  • NSC #119875
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: lomustine
Given orally
Other Names:
  • Cyclohexylchloroethylnitrosourea
  • CCNU
  • CeeNU
  • NSC #79037
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
Experimental: Arm VI (reduced craniospinal XRT, XRT fossa & Regimen B)
Patients undergo reduced-dose craniospinal radiation therapy with boost. Standard volume boost (radiation to the entire posterior fossa. Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine sulfate IV on days 1 and 8 of weeks 23, 39, and 55.
Drug: cisplatin
Given IV
Other Names:
  • Cis-diamminedichloroplatinum II
  • CDDP
  • cis-DDP
  • Platinol-AQ
  • NSC #119875
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
Experimental: Arm VII (std craniospinal XRT, XRT fossa & Regimen A)
Patients undergo standard-dose craniospinal radiation therapy with boost. Smaller volume boost radiation to tumor bed. Patients receive oral lomustine and cisplatin IV over 6 hours on day 1 and vincristine sulfate IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49.
Drug: cisplatin
Given IV
Other Names:
  • Cis-diamminedichloroplatinum II
  • CDDP
  • cis-DDP
  • Platinol-AQ
  • NSC #119875
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: lomustine
Given orally
Other Names:
  • Cyclohexylchloroethylnitrosourea
  • CCNU
  • CeeNU
  • NSC #79037
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
Experimental: Arm VIII (std craniospinal XRT, XRT fossa & Regimen B)
Patients undergo standard-dose craniospinal radiation therapy with boost. Standard volume boost (radiation to the entire posterior fossa. Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine sulfate IV on days 1 and 8 of weeks 23, 39, and 55.
Drug: cisplatin
Given IV
Other Names:
  • Cis-diamminedichloroplatinum II
  • CDDP
  • cis-DDP
  • Platinol-AQ
  • NSC #119875
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: vincristine sulfate
Given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 3 to 21 at diagnosis

Performance status

  • Karnofsky 50-100% (> 16 years of age) OR
  • Lansky 30-100% (≤ 16 years of age)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3 (transfusion independent)
  • Hemoglobin > 10 g/dL (transfusions allowed)

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST or ALT < 1.5 times ULN

Renal

  • Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min

Other

  • 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 corticosteroids allowed

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085735

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
United States, California
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048-1865
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital and Research Center Oakland
Oakland, California, United States, 94609
Children's Hospital of Orange County
Orange, California, United States, 92868
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 95798
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95661
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
Children's Hospital Colorado Center for Cancer and Blood Disorders
Aurora, Colorado, United States, 80045
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States, 33316
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Miami Children's Hospital
Miami, Florida, United States, 33155
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States, 30322
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Tripler AMC, Hawaii, United States, 96859-5000
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712-6297
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60611
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Keyser Family Cancer Center at Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61603
Simmons Cooper Cancer Institute
Springfield, Illinois, United States, 62794-9677
United States, Indiana
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70118
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
United States, Maine
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program at Barbara Bush Children's Hospital
Scarborough, Maine, United States, 04074-9308
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
National Naval Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0286
Hurley Medical Center
Flint, Michigan, United States, 48503
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007-5381
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Children's Hospitals and Clinics of Minnesota - St. Paul
St. Paul, Minnesota, United States, 55102-2392
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Hospital
St. Louis, Missouri, United States, 63104
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St. Louis, Missouri, United States, 63110
United States, Nebraska
Children's Hospital
Omaha, Nebraska, United States, 68114-4113
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89109-2306
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Summit, New Jersey, United States, 07901
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208-3419
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Winthrop University Hospital
Mineola, New York, United States, 11501
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-9446
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308-1062
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205-2696
Dayton Children's - Dayton
Dayton, Ohio, United States, 45404-1815
Mercy Children's Hospital
Toledo, Ohio, United States, 43608
Toledo Hospital
Toledo, Ohio, United States, 43606
Tod Children's Hospital
Youngstown, Ohio, United States, 44501
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033-0850
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
T.C. Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37916
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States, 79106
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2399
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507-1971
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Carilion Medical Center for Children at Roanoke Community Hospital
Roanoke, Virginia, United States, 24014
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99220-2555
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431
United States, West Virginia
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States, 25302
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, South Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Children's and Women's Hospital of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Children's Hospital of Western Ontario
London, Ontario, Canada, N6A 5W9
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3H 1P3
Canada, Saskatchewan
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
Centre Hospitalier Universitaire de Quebec
Quebec, Canada, G1V 4G2
Netherlands
Dutch Childhood Oncology Group
The Hague, Netherlands, 2504 AM
New Zealand
Starship Children's Health
Auckland, New Zealand, 1
Christchurch Hospital
Christchurch, New Zealand, 8140
Wellington Children's Hospital
Wellington, New Zealand, 6002
Puerto Rico
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, 3010
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, 1205
Swiss Pediatric Oncology Group Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Jeff M. Michalski, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00085735     History of Changes
Other Study ID Numbers: ACNS0331, COG-ACNS0331, CDR0000365506
Study First Received: June 14, 2004
Last Updated: August 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
untreated childhood medulloblastoma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Medulloblastoma
Neoplasms
Nervous System Neoplasms
Glioma
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Cisplatin
Cyclophosphamide
Lomustine
Vincristine
Alkylating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 19, 2014