Combination Chemotherapy in Treating Children With Neuroblastoma
31. juli 2014 opdateret af: Children's Oncology Group
Treatment for Infants and Children With Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Combination chemotherapy plus surgery may be an effective treatment for neuroblastoma.
PURPOSE: This phase III trial is studying how well combination chemotherapy followed by surgery works in treating young patients with neuroblastoma.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
- Determine whether the use of selected prognostic variables to assign treatment increases the event-free survival and overall survival in children with intermediate-risk neuroblastoma.
- Determine the acute and long-term morbidity and toxicity of surgery and combination chemotherapy in this patient population.
- Assess the relationship between extent of tumor resection and event-free and overall survival in patients treated with this regimen.
OUTLINE: Patients receive carboplatin IV over 1 hour on days 0, 21, and 63; cyclophosphamide IV over 1 hour on days 21 and 42; doxorubicin IV over 15-60 minutes on days 21 and 63; and etoposide IV over 2 hours on days 0-2, 42-44, and 63-65. Patients under 60 days of age also receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after the last chemotherapy administration and continuing until blood counts recover. Patients with favorable biology who do not achieve complete remission then undergo surgery to remove or debulk residual disease on day 84 or when blood counts recover. Patients with favorable biology who achieve partial response and surgery to the primary site is not deemed in the best interest of the patient may receive additional chemotherapy (as below) and delay surgery to the primary site after completion of chemotherapy.
Patients with unfavorable biology receive additional chemotherapy comprising cyclophosphamide IV over 1 hour on days 84, 105, and 147; etoposide IV over 2 hours on days 84-86 and 126-128; carboplatin IV over 1 hour on days 105 and 126; and doxorubicin IV over 15-60 minutes on days 105 and 147. Patients then undergo debulking surgery on day 168 or when blood counts recover.
Some patients may then undergo radiotherapy after surgery.
Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
573
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Randwick, New South Wales, Australien, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Australien, 2145
- Children's Hospital at Westmead
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Queensland
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Brisbane, Queensland, Australien, 4029
- Royal Children's Hospital
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South Australia
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North Adelaide, South Australia, Australien, 5006
- Women's and Children's Hospital
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Victoria
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Parkville, Victoria, Australien, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australien, 6001
- Princess Margaret Hospital for Children
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Alberta
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Calgary, Alberta, Canada, T2T 5C7
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute at University of Alberta
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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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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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, NS B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8S 4J9
- McMaster Children's Hospital at Hamilton Health Sciences
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London, Ontario, Canada, N6C 2V5
- Children's Hospital of Western Ontario
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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
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Canada, H3T 1C5
- Hôpital Sainte Justine
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Sainte Foy, Quebec, Canada, GIV 4G2
- Centre de Recherche du Centre Hospitalier de l'Universite Laval
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- Comprehensive Cancer Center at University of Alabama at Birmingham
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Mobile, Alabama, Forenede Stater, 36604
- University of South Alabama Cancer Research Institute
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Arizona
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Phoenix, Arizona, Forenede Stater, 85016
- Phoenix Children's Hospital
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Forenede Stater, 90242
- Southern California Permanente Medical Group
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Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, Forenede Stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Forenede Stater, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Forenede Stater, 90027-0700
- Children's Hospital Los Angeles
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Los Angeles, California, Forenede Stater, 90048
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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Madera, California, Forenede Stater, 93638-8762
- Children's Hospital Central California
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Oakland, California, Forenede Stater, 94609-1809
- Children's Hospital and Research Center - Oakland
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Orange, California, Forenede Stater, 92868
- Children's Hospital of Orange County
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Orange, California, Forenede Stater, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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Palo Alto, California, Forenede Stater, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Forenede Stater, 95816
- Sutter Cancer Center
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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Sacramento, California, Forenede Stater, 95825
- Kaiser Permanente Medical Center - Sacramento
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San Diego, California, Forenede Stater, 92123-4282
- Children's Hospital and Health Center - San Diego
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San Diego, California, Forenede Stater, 92120
- Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
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San Francisco, California, Forenede Stater, 94143
- UCSF Comprehensive Cancer Center
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Santa Barbara, California, Forenede Stater, 93102
- Santa Barbara Cottage Children's Hospital
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Santa Clara, California, Forenede Stater, 95051
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
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Travis Air Force Base, California, Forenede Stater, 94535
- General Robert Huyser Cancer Center at David Grant Medical Center
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Forenede Stater, 80218
- Children's Hospital Cancer Center
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06360-7106
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
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New Haven, Connecticut, Forenede Stater, 06520-8064
- Yale Comprehensive Cancer Center at Yale University School of Medicine
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Delaware
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Wilmington, Delaware, Forenede Stater, 19899
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Forenede Stater, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Forenede Stater, 33908
- Children's Hospital of Southwest Florida
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Gainesville, Florida, Forenede Stater, 32610-0296
- University of Florida Shands Cancer Center
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Hollywood, Florida, Forenede Stater, 33021
- Joe DiMaggio Children's Hospital at Memorial
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Jacksonville, Florida, Forenede Stater, 32207
- Nemours Children's Clinic
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Miami, Florida, Forenede Stater, 33155
- Miami Children's Hospital
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Miami, Florida, Forenede Stater, 33136
- Jackson Memorial Hospital
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Miami, Florida, Forenede Stater, 33176-2197
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Forenede Stater, 32804
- Florida Hospital Cancer Institute
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Orlando, Florida, Forenede Stater, 32806
- Nemours Children's Clinic - Orlando
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Pensacola, Florida, Forenede Stater, 32504
- Sacred Heart Children's Hospital
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St. Petersburg, Florida, Forenede Stater, 33701
- All Children's Hospital
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Tampa, Florida, Forenede Stater, 33677-4227
- St. Joseph's Children's Hospital of Tampa
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West Palm Beach, Florida, Forenede Stater, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
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Augusta, Georgia, Forenede Stater, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
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Macon, Georgia, Forenede Stater, 31201
- Medical Center of Central Georgia
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Savannah, Georgia, Forenede Stater, 31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Forenede Stater, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- MBCCOP - Hawaii
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Idaho
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Boise, Idaho, Forenede Stater, 83712
- St. Luke's Mountain States Tumor Institute - Boise
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forenede Stater, 60614
- Children's Memorial Hospital - Chicago
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Chicago, Illinois, Forenede Stater, 60601
- University of Chicago Cancer Research Center
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois at Chicago Cancer Center
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Oak Lawn, Illinois, Forenede Stater, 60453
- Advocate Hope Children's Hospital
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Park Ridge, Illinois, Forenede Stater, 60068-1174
- Lutheran General Cancer Care Center
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Peoria, Illinois, Forenede Stater, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Forenede Stater, 62794-9658
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46260
- St. Vincent Indianapolis Hospital
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Indianapolis, Indiana, Forenede Stater, 46202-5225
- Riley's Children Cancer Center at Riley Hospital for Children
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Iowa
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Des Moines, Iowa, Forenede Stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Forenede Stater, 50308
- Blank Children's Hospital
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Iowa City, Iowa, Forenede Stater, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Wichita, Kansas, Forenede Stater, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0284
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisville, Kentucky, Forenede Stater, 40202-3830
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Pediatric Specialty Clinic at Eastern Maine Medical Center
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Scarborough, Maine, Forenede Stater, 04074-9308
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Forenede Stater, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Baltimore, Maryland, Forenede Stater, 21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Forenede Stater, 21231-7223
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Silver Spring, Maryland, Forenede Stater, 20910
- Walter Reed Army Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02111
- Floating Hospital for Children
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Springfield, Massachusetts, Forenede Stater, 01107
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
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Worcester, Massachusetts, Forenede Stater, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0914
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forenede Stater, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Forenede Stater, 49503
- DeVos Children's Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007-5364
- Bronson Methodist Hospital
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Lansing, Michigan, Forenede Stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Royal Oak, Michigan, Forenede Stater, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Forenede Stater, 48073-6769
- William Beaumont Hospital - Royal Oak Campus
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Minneapolis, Minnesota, Forenede Stater, 55404
- Children's Hospitals and Clinics - Minneapolis/St. Paul
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
- University of Missouri - Columbia
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Forenede Stater, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, Forenede Stater, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Children's Hospital of Omaha
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Omaha, Nebraska, Forenede Stater, 68198-2168
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109
- Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, Forenede Stater, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Forenede Stater, 07112-2094
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Forenede Stater, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, Forenede Stater, 07901
- Valerie Fund Children's Center at Atlantic Health
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131
- University of New Mexico Cancer Research and Treatment Center
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New York
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Albany, New York, Forenede Stater, 12208
- Children's Hospital at Albany Medical Center
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Bronx, New York, Forenede Stater, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Forenede Stater, 11219
- Maimonides Medical Center
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Brooklyn, New York, Forenede Stater, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, Forenede Stater, 11212
- Brookdale University Hospital and Medical Center
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Brooklyn, New York, Forenede Stater, 11201-5493
- Brooklyn Hospital Center
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Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
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New Hyde Park, New York, Forenede Stater, 11040
- Schneider Children's Hospital
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forenede Stater, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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New York, New York, Forenede Stater, 10029
- Mount Sinai Medical Center
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Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Forenede Stater, 11794-8174
- Long Island Cancer Center at Stony Brook University Hospital
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Forenede Stater, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospitals - Memorial Campus
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, Forenede Stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Forenede Stater, 28233
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Forenede Stater, 27858-4354
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
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Winston-Salem, North Carolina, Forenede Stater, 27157-1081
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58103-4940
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
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Ohio
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Akron, Ohio, Forenede Stater, 44308-1062
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Forenede Stater, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, Forenede Stater, 43205-2696
- Columbus Children's Hospital
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Dayton, Ohio, Forenede Stater, 45404
- Children's Medical Center - Dayton
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Toledo, Ohio, Forenede Stater, 43601
- Toledo Children's Hospital
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Toledo, Ohio, Forenede Stater, 43608
- St. Vincent Mercy Medical Center
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Youngstown, Ohio, Forenede Stater, 44501
- Tod Children's Hospital - Forum Health
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Children's Hospital at Oklahoma University Medical Center
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Tulsa, Oklahoma, Forenede Stater, 74136
- CCOP - Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Oregon
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Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
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Portland, Oregon, Forenede Stater, 97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
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Pennsylvania
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Danville, Pennsylvania, Forenede Stater, 17822-1320
- Geisinger Medical Center
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Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425-0721
- Hollings Cancer Center at Medical University of South Carolina
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Columbia, South Carolina, Forenede Stater, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, Forenede Stater, 29605
- Children's Hospital of Greenville Hospital System
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
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Sioux Falls, South Dakota, Forenede Stater, 57105-1080
- Avera Cancer Institute
-
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Tennessee
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Johnson City, Tennessee, Forenede Stater, 37614-0622
- East Tennessee State University Cancer Center at Johnson City Medical Center
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Knoxville, Tennessee, Forenede Stater, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Forenede Stater, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Forenede Stater, 37232-6310
- Vanderbilt Children's Hospital
-
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- Texas Tech University Health Sciences Center School of Medicine
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Austin, Texas, Forenede Stater, 78701
- Children's Hospital of Austin
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Dallas, Texas, Forenede Stater, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Forenede Stater, 75390-9063
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center - Fort Worth
-
Galveston, Texas, Forenede Stater, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, Forenede Stater, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
-
Houston, Texas, Forenede Stater, 77030
- Cancer Center at Baylor College of Medicine
-
Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
- Wilford Hall Medical Center
-
Lubbock, Texas, Forenede Stater, 79410
- Covenant Children's Hospital
-
San Antonio, Texas, Forenede Stater, 78207
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Forenede Stater, 78229-3900
- MBCCOP - South Texas Pediatrics
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San Antonio, Texas, Forenede Stater, 78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Temple, Texas, Forenede Stater, 76508
- Center for Cancer Prevention and Care at Scott and White Clinic
-
-
Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute at University of Utah
-
-
Vermont
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Burlington, Vermont, Forenede Stater, 05401-3498
- Vermont Cancer Center at University of Vermont
-
-
Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Cancer Center
-
Falls Church, Virginia, Forenede Stater, 22042-3300
- INOVA Fairfax Hospital
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Norfolk, Virginia, Forenede Stater, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, Forenede Stater, 23708-5100
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, Forenede Stater, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
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Roanoke, Virginia, Forenede Stater, 24029
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
-
Seattle, Washington, Forenede Stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forenede Stater, 98112
- Group Health Central Hospital
-
Spokane, Washington, Forenede Stater, 99210-0248
- Deaconess Medical Center
-
Tacoma, Washington, Forenede Stater, 98415-0299
- Mary Bridge Children's Hospital and Health Center - Tacoma
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Tacoma, Washington, Forenede Stater, 98431-0001
- Madigan Army Medical Center
-
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West Virginia
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Charleston, West Virginia, Forenede Stater, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
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Huntington, West Virginia, Forenede Stater, 25701
- Cabell Huntington Hospital
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Morgantown, West Virginia, Forenede Stater, 26506-9300
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
-
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Green Bay, Wisconsin, Forenede Stater, 54301
- Bellin Memorial Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54307-9070
- St. Vincent Hospital
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Forenede Stater, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, Forenede Stater, 54449
- CCOP - Marshfield Clinic Research Foundation
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Marshfield, Wisconsin, Forenede Stater, 54449-5772
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Midwest Children's Cancer Center
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Groningen, Holland, 9700 RB
- University Medical Center Groningen
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Auckland, New Zealand
- Starship Children's Health
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San Juan, Puerto Rico, 00936-5067
- Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
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Santurce, Puerto Rico, 00912
- San Jorge Children's Hospital
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Bern, Schweiz, CH 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Schweiz, CH 1211
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Schweiz, CH 1011
- Swiss Pediatric Oncology Group Lausanne
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 20 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically proven neuroblastoma or maturing ganglioneuroma that is judged to be intermediate risk by one of the following criteria:
International Neuroblastoma Staging System (INSS) stage III
- Under 1 year old, MYCN oncogene nonamplified, and any ploidy
- 1 to 20 years old, MYCN nonamplified, favorable Shimada histology
INSS stage IV
- Under 1 year old, MYCN nonamplified, any ploidy
INSS stage IVS
- Under 1 year old, MYCN nonamplified, unfavorable Shimada histology and any ploidy OR favorable Shimada histology and diploidy
- All patients must be registered on the companion neuroblastoma biology study (COG-ANBL00B1)
PATIENT CHARACTERISTICS:
Age:
- Under 21
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No abnormal organ function that would prohibit chemotherapy unless due to neuroblastoma
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior chemotherapy for patients with intradural extension and emergent paresis allowed provided biopsy was performed within 96 hours after treatment
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No other prior therapy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Behandling
Se detaljeret beskrivelse.
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Andre navne:
Andre navne:
Andre navne:
Andre navne:
Andre navne:
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Begivenhedsfri overlevelse
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: David L. Baker, MD, MBBS, FRACP, FRCPA, Princess Margaret Hospital for Children
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Dubois SG, Geier E, Batra V, Yee SW, Neuhaus J, Segal M, Martinez D, Pawel B, Yanik G, Naranjo A, London WB, Kreissman S, Baker D, Attiyeh E, Hogarty MD, Maris JM, Giacomini K, Matthay KK. Evaluation of Norepinephrine Transporter Expression and Metaiodobenzylguanidine Avidity in Neuroblastoma: A Report from the Children's Oncology Group. Int J Mol Imaging. 2012;2012:250834. doi: 10.1155/2012/250834. Epub 2012 Sep 25.
- Marachelian A, Shimada H, Sano H, Jackson H, Stein J, Sposto R, Matthay KK, Baker D, Villablanca JG. The significance of serial histopathology in a residual mass for outcome of intermediate risk stage 3 neuroblastoma. Pediatr Blood Cancer. 2012 May;58(5):675-81. doi: 10.1002/pbc.23250.
- Meany HJ, Attiyeh EF, Naranjo A, et al.: Outcome analysis of non-high-risk neuroblastoma patients enrolled on Children's Oncology Group trials P9641 and A3961. [Abstract] J Clin Oncol 30 (Suppl 15): A-9533, 2012.
- Attiyeh EF, Mosse YP, Diskin S, et al.: Identification of genomic DNA signatures predicting relapse in low- and intermediate- risk neuroblastoma using a case control design and high-density SNP genotyping: a Children's Oncology Group (COG) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9500, 526s, 2007.
- Baker DL, Schmidt ML, Cohn SL, Maris JM, London WB, Buxton A, Stram D, Castleberry RP, Shimada H, Sandler A, Shamberger RC, Look AT, Reynolds CP, Seeger RC, Matthay KK; Children's Oncology Group. Outcome after reduced chemotherapy for intermediate-risk neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1313-23. doi: 10.1056/NEJMoa1001527.
- Baker DL, Schmidt M, Cohn S, et al.: A phase III trial of biologically-based therapy reduction for intermediate risk neuroblastoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-9504, 2007.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 1988
Primær færdiggørelse (Faktiske)
1. september 2006
Studieafslutning (Faktiske)
1. januar 2011
Datoer for studieregistrering
Først indsendt
1. november 1999
Først indsendt, der opfyldte QC-kriterier
26. januar 2003
Først opslået (Skøn)
27. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroektodermale tumorer, primitive
- Neuroektodermale tumorer, primitive, perifere
- Neuroblastom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Adjuvanser, immunologiske
- Antibiotika, antineoplastisk
- Cyclofosfamid
- Carboplatin
- Etoposid
- Lenograstim
- Doxorubicin
- Liposomal doxorubicin
- Sargramostim
- Molgramostim
Andre undersøgelses-id-numre
- A3961
- COG-A3961 (Anden identifikator: Children's Oncology Group)
- CCG-A3961 (Anden identifikator: Children's Cancer Group)
- POG-A3961 (Anden identifikator: Pediatric Oncology Group)
- CDR0000065804 (Anden identifikator: Clinical Trials.gov)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .