Combination Chemotherapy in Treating Children With Neuroblastoma
31 luglio 2014 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
573
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New South Wales
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Randwick, New South Wales, Australia, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Australia, 2145
- Children's Hospital at Westmead
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Queensland
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Brisbane, Queensland, Australia, 4029
- Royal Children's Hospital
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South Australia
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North Adelaide, South Australia, Australia, 5006
- Women's and Children's Hospital
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 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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Auckland, Nuova Zelanda
- Starship Children's Health
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Groningen, Olanda, 9700 RB
- University Medical Center Groningen
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San Juan, Porto Rico, 00936-5067
- Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
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Santurce, Porto Rico, 00912
- San Jorge Children's Hospital
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- Comprehensive Cancer Center at University of Alabama at Birmingham
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Mobile, Alabama, Stati Uniti, 36604
- University of South Alabama Cancer Research Institute
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Arizona
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Phoenix, Arizona, Stati Uniti, 85016
- Phoenix Children's Hospital
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Tucson, Arizona, Stati Uniti, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Stati Uniti, 90242
- Southern California Permanente Medical Group
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Duarte, California, Stati Uniti, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, Stati Uniti, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Loma Linda, California, Stati Uniti, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Stati Uniti, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Stati Uniti, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Stati Uniti, 90027-0700
- Children's Hospital Los Angeles
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Los Angeles, California, Stati Uniti, 90048
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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Madera, California, Stati Uniti, 93638-8762
- Children's Hospital Central California
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Oakland, California, Stati Uniti, 94609-1809
- Children's Hospital and Research Center - Oakland
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Orange, California, Stati Uniti, 92868
- Children's Hospital of Orange County
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Orange, California, Stati Uniti, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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Palo Alto, California, Stati Uniti, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Stati Uniti, 95816
- Sutter Cancer Center
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Sacramento, California, Stati Uniti, 95817
- University of California Davis Cancer Center
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Sacramento, California, Stati Uniti, 95825
- Kaiser Permanente Medical Center - Sacramento
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San Diego, California, Stati Uniti, 92123-4282
- Children's Hospital and Health Center - San Diego
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San Diego, California, Stati Uniti, 92120
- Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
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San Francisco, California, Stati Uniti, 94143
- UCSF Comprehensive Cancer Center
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Santa Barbara, California, Stati Uniti, 93102
- Santa Barbara Cottage Children's Hospital
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Santa Clara, California, Stati Uniti, 95051
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
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Travis Air Force Base, California, Stati Uniti, 94535
- General Robert Huyser Cancer Center at David Grant Medical Center
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Colorado
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Denver, Colorado, Stati Uniti, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Stati Uniti, 80218
- Children's Hospital Cancer Center
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Connecticut
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Farmington, Connecticut, Stati Uniti, 06360-7106
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
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New Haven, Connecticut, Stati Uniti, 06520-8064
- Yale Comprehensive Cancer Center at Yale University School of Medicine
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Delaware
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Wilmington, Delaware, Stati Uniti, 19899
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Stati Uniti, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Stati Uniti, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Stati Uniti, 33908
- Children's Hospital of Southwest Florida
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Gainesville, Florida, Stati Uniti, 32610-0296
- University of Florida Shands Cancer Center
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Hollywood, Florida, Stati Uniti, 33021
- Joe DiMaggio Children's Hospital at Memorial
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Jacksonville, Florida, Stati Uniti, 32207
- Nemours Children's Clinic
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Miami, Florida, Stati Uniti, 33155
- Miami Children's Hospital
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Miami, Florida, Stati Uniti, 33136
- Jackson Memorial Hospital
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Miami, Florida, Stati Uniti, 33176-2197
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Stati Uniti, 32804
- Florida Hospital Cancer Institute
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Orlando, Florida, Stati Uniti, 32806
- Nemours Children's Clinic - Orlando
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Pensacola, Florida, Stati Uniti, 32504
- Sacred Heart Children's Hospital
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St. Petersburg, Florida, Stati Uniti, 33701
- All Children's Hospital
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Tampa, Florida, Stati Uniti, 33677-4227
- St. Joseph's Children's Hospital of Tampa
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West Palm Beach, Florida, Stati Uniti, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
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Augusta, Georgia, Stati Uniti, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
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Macon, Georgia, Stati Uniti, 31201
- Medical Center of Central Georgia
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Savannah, Georgia, Stati Uniti, 31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Stati Uniti, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813
- MBCCOP - Hawaii
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Idaho
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Boise, Idaho, Stati Uniti, 83712
- St. Luke's Mountain States Tumor Institute - Boise
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Rush University Medical Center
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Chicago, Illinois, Stati Uniti, 60614
- Children's Memorial Hospital - Chicago
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Chicago, Illinois, Stati Uniti, 60601
- University of Chicago Cancer Research Center
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Chicago, Illinois, Stati Uniti, 60612
- University of Illinois at Chicago Cancer Center
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Oak Lawn, Illinois, Stati Uniti, 60453
- Advocate Hope Children's Hospital
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Park Ridge, Illinois, Stati Uniti, 60068-1174
- Lutheran General Cancer Care Center
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Peoria, Illinois, Stati Uniti, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Stati Uniti, 62794-9658
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46260
- St. Vincent Indianapolis Hospital
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Indianapolis, Indiana, Stati Uniti, 46202-5225
- Riley's Children Cancer Center at Riley Hospital for Children
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Iowa
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Des Moines, Iowa, Stati Uniti, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Stati Uniti, 50308
- Blank Children's Hospital
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Iowa City, Iowa, Stati Uniti, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Wichita, Kansas, Stati Uniti, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40536-0284
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisville, Kentucky, Stati Uniti, 40202-3830
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Stati Uniti, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Stati Uniti, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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New Orleans, Louisiana, Stati Uniti, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Bangor, Maine, Stati Uniti, 04401
- Pediatric Specialty Clinic at Eastern Maine Medical Center
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Scarborough, Maine, Stati Uniti, 04074-9308
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Stati Uniti, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Baltimore, Maryland, Stati Uniti, 21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Stati Uniti, 21231-7223
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Silver Spring, Maryland, Stati Uniti, 20910
- Walter Reed Army Medical Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Stati Uniti, 02111
- Floating Hospital for Children
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Springfield, Massachusetts, Stati Uniti, 01107
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
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Worcester, Massachusetts, Stati Uniti, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109-0914
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Stati Uniti, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Stati Uniti, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Flint, Michigan, Stati Uniti, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Stati Uniti, 49503
- DeVos Children's Hospital
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Kalamazoo, Michigan, Stati Uniti, 49007-5364
- Bronson Methodist Hospital
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Lansing, Michigan, Stati Uniti, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Royal Oak, Michigan, Stati Uniti, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Stati Uniti, 48073-6769
- William Beaumont Hospital - Royal Oak Campus
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Minnesota
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Duluth, Minnesota, Stati Uniti, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Minneapolis, Minnesota, Stati Uniti, 55404
- Children's Hospitals and Clinics - Minneapolis/St. Paul
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Stati Uniti, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, Stati Uniti, 65203
- University of Missouri - Columbia
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Kansas City, Missouri, Stati Uniti, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Stati Uniti, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, Stati Uniti, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68114
- Children's Hospital of Omaha
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Omaha, Nebraska, Stati Uniti, 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, Stati Uniti, 89109
- Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, Stati Uniti, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Stati Uniti, 07112-2094
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Stati Uniti, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, Stati Uniti, 07901
- Valerie Fund Children's Center at Atlantic Health
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87131
- University of New Mexico Cancer Research and Treatment Center
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New York
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Albany, New York, Stati Uniti, 12208
- Children's Hospital at Albany Medical Center
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Bronx, New York, Stati Uniti, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Stati Uniti, 11219
- Maimonides Medical Center
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Brooklyn, New York, Stati Uniti, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, Stati Uniti, 11212
- Brookdale University Hospital and Medical Center
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Brooklyn, New York, Stati Uniti, 11201-5493
- Brooklyn Hospital Center
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Buffalo, New York, Stati Uniti, 14263-0001
- Roswell Park Cancer Institute
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New Hyde Park, New York, Stati Uniti, 11040
- Schneider Children's Hospital
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New York, New York, Stati Uniti, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Stati Uniti, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Stati Uniti, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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New York, New York, Stati Uniti, 10029
- Mount Sinai Medical Center
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Rochester, New York, Stati Uniti, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Stati Uniti, 11794-8174
- Long Island Cancer Center at Stony Brook University Hospital
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Syracuse, New York, Stati Uniti, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Stati Uniti, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Stati Uniti, 28801
- Mission Hospitals - Memorial Campus
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Chapel Hill, North Carolina, Stati Uniti, 27599
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, Stati Uniti, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Stati Uniti, 28233
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Stati Uniti, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Stati Uniti, 27858-4354
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
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Winston-Salem, North Carolina, Stati Uniti, 27157-1081
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, Stati Uniti, 58103-4940
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
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Ohio
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Akron, Ohio, Stati Uniti, 44308-1062
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Stati Uniti, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Stati Uniti, 44106-5065
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, Stati Uniti, 43205-2696
- Columbus Children's Hospital
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Dayton, Ohio, Stati Uniti, 45404
- Children's Medical Center - Dayton
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Toledo, Ohio, Stati Uniti, 43601
- Toledo Children's Hospital
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Toledo, Ohio, Stati Uniti, 43608
- St. Vincent Mercy Medical Center
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Youngstown, Ohio, Stati Uniti, 44501
- Tod Children's Hospital - Forum Health
-
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Children's Hospital at Oklahoma University Medical Center
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Tulsa, Oklahoma, Stati Uniti, 74136
- CCOP - Oklahoma
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Tulsa, Oklahoma, Stati Uniti, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Oregon
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Portland, Oregon, Stati Uniti, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Stati Uniti, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
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Portland, Oregon, Stati Uniti, 97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
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Pennsylvania
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Danville, Pennsylvania, Stati Uniti, 17822-1320
- Geisinger Medical Center
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Hershey, Pennsylvania, Stati Uniti, 17033
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Stati Uniti, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425-0721
- Hollings Cancer Center at Medical University of South Carolina
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Columbia, South Carolina, Stati Uniti, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, Stati Uniti, 29605
- Children's Hospital of Greenville Hospital System
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South Dakota
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Sioux Falls, South Dakota, Stati Uniti, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
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Sioux Falls, South Dakota, Stati Uniti, 57105-1080
- Avera Cancer Institute
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Tennessee
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Johnson City, Tennessee, Stati Uniti, 37614-0622
- East Tennessee State University Cancer Center at Johnson City Medical Center
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Knoxville, Tennessee, Stati Uniti, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Stati Uniti, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Stati Uniti, 37232-6310
- Vanderbilt Children's Hospital
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Texas
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Amarillo, Texas, Stati Uniti, 79106
- Texas Tech University Health Sciences Center School of Medicine
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Austin, Texas, Stati Uniti, 78701
- Children's Hospital of Austin
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Dallas, Texas, Stati Uniti, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Stati Uniti, 75390-9063
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Stati Uniti, 76104
- Cook Children's Medical Center - Fort Worth
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Galveston, Texas, Stati Uniti, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Stati Uniti, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
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Houston, Texas, Stati Uniti, 77030
- Cancer Center at Baylor College of Medicine
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Lackland Air Force Base, Texas, Stati Uniti, 78236-5300
- Wilford Hall Medical Center
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Lubbock, Texas, Stati Uniti, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Stati Uniti, 78207
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Stati Uniti, 78229-3900
- MBCCOP - South Texas Pediatrics
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San Antonio, Texas, Stati Uniti, 78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
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Temple, Texas, Stati Uniti, 76508
- CCOP - Scott and White Hospital
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Temple, Texas, Stati Uniti, 76508
- Center for Cancer Prevention and Care at Scott and White Clinic
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Utah
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Salt Lake City, Utah, Stati Uniti, 84112
- Huntsman Cancer Institute at University of Utah
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Vermont
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Burlington, Vermont, Stati Uniti, 05401-3498
- Vermont Cancer Center at University of Vermont
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22908
- University of Virginia Cancer Center
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Falls Church, Virginia, Stati Uniti, 22042-3300
- INOVA Fairfax Hospital
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Norfolk, Virginia, Stati Uniti, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, Stati Uniti, 23708-5100
- Naval Medical Center - Portsmouth
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Richmond, Virginia, Stati Uniti, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
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Roanoke, Virginia, Stati Uniti, 24029
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Seattle, Washington, Stati Uniti, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Seattle, Washington, Stati Uniti, 98109-1024
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Stati Uniti, 98112
- Group Health Central Hospital
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Spokane, Washington, Stati Uniti, 99210-0248
- Deaconess Medical Center
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Tacoma, Washington, Stati Uniti, 98415-0299
- Mary Bridge Children's Hospital and Health Center - Tacoma
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Tacoma, Washington, Stati Uniti, 98431-0001
- Madigan Army Medical Center
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West Virginia
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Charleston, West Virginia, Stati Uniti, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
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Huntington, West Virginia, Stati Uniti, 25701
- Cabell Huntington Hospital
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Morgantown, West Virginia, Stati Uniti, 26506-9300
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Stati Uniti, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, Stati Uniti, 54301
- Bellin Memorial Hospital
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Green Bay, Wisconsin, Stati Uniti, 54307-9070
- St. Vincent Hospital
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La Crosse, Wisconsin, Stati Uniti, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Stati Uniti, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, Stati Uniti, 54449
- CCOP - Marshfield Clinic Research Foundation
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Marshfield, Wisconsin, Stati Uniti, 54449-5772
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Midwest Children's Cancer Center
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Bern, Svizzera, CH 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Svizzera, CH 1211
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Svizzera, CH 1011
- Swiss Pediatric Oncology Group Lausanne
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Non più vecchio di 20 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Trattamento
Vedi descrizione dettagliata.
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Altri nomi:
Altri nomi:
Altri nomi:
Altri nomi:
Altri nomi:
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Sopravvivenza senza eventi
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: David L. Baker, MD, MBBS, FRACP, FRCPA, Princess Margaret Hospital for Children
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 1988
Completamento primario (Effettivo)
1 settembre 2006
Completamento dello studio (Effettivo)
1 gennaio 2011
Date di iscrizione allo studio
Primo inviato
1 novembre 1999
Primo inviato che soddisfa i criteri di controllo qualità
26 gennaio 2003
Primo Inserito (Stima)
27 gennaio 2003
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
1 agosto 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 luglio 2014
Ultimo verificato
1 luglio 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie, Neuroepiteliali
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Tumori neuroectodermici, primitivi
- Tumori neuroectodermici, primitivi, periferici
- Neuroblastoma
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antireumatici
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti Antineoplastici, Alchilanti
- Agenti Alchilanti
- Agonisti mieloablativi
- Agenti antineoplastici, fitogenici
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Adiuvanti, immunologici
- Antibiotici, Antineoplastici
- Ciclofosfamide
- Carboplatino
- Etoposide
- Lenograstim
- Doxorubicina
- Doxorubicina liposomiale
- Sargramostim
- Molgramostim
Altri numeri di identificazione dello studio
- A3961
- COG-A3961 (Altro identificatore: Children's Oncology Group)
- CCG-A3961 (Altro identificatore: Children's Cancer Group)
- POG-A3961 (Altro identificatore: Pediatric Oncology Group)
- CDR0000065804 (Altro identificatore: Clinical Trials.gov)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .