Combination Chemotherapy in Treating Children With Neuroblastoma
31 juli 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
573
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New South Wales
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Randwick, New South Wales, Australië, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Australië, 2145
- Children's Hospital at Westmead
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Queensland
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Brisbane, Queensland, Australië, 4029
- Royal Children's Hospital
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South Australia
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North Adelaide, South Australia, Australië, 5006
- Women's and Children's Hospital
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Victoria
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Parkville, Victoria, Australië, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australië, 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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Groningen, Nederland, 9700 RB
- University Medical Center Groningen
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Auckland, Nieuw-Zeeland
- 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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Alabama
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Birmingham, Alabama, Verenigde Staten, 35233
- Comprehensive Cancer Center at University of Alabama at Birmingham
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Mobile, Alabama, Verenigde Staten, 36604
- University of South Alabama Cancer Research Institute
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85016
- Phoenix Children's Hospital
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Tucson, Arizona, Verenigde Staten, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Verenigde Staten, 90242
- Southern California Permanente Medical Group
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Duarte, California, Verenigde Staten, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, Verenigde Staten, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Loma Linda, California, Verenigde Staten, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Verenigde Staten, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Verenigde Staten, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Verenigde Staten, 90027-0700
- Children's Hospital Los Angeles
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Los Angeles, California, Verenigde Staten, 90048
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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Madera, California, Verenigde Staten, 93638-8762
- Children's Hospital Central California
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Oakland, California, Verenigde Staten, 94609-1809
- Children's Hospital and Research Center - Oakland
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Orange, California, Verenigde Staten, 92868
- Children's Hospital of Orange County
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Orange, California, Verenigde Staten, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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Palo Alto, California, Verenigde Staten, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Verenigde Staten, 95816
- Sutter Cancer Center
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Sacramento, California, Verenigde Staten, 95817
- University of California Davis Cancer Center
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Sacramento, California, Verenigde Staten, 95825
- Kaiser Permanente Medical Center - Sacramento
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San Diego, California, Verenigde Staten, 92123-4282
- Children's Hospital and Health Center - San Diego
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San Diego, California, Verenigde Staten, 92120
- Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
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San Francisco, California, Verenigde Staten, 94143
- UCSF Comprehensive Cancer Center
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Santa Barbara, California, Verenigde Staten, 93102
- Santa Barbara Cottage Children's Hospital
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Santa Clara, California, Verenigde Staten, 95051
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
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Travis Air Force Base, California, Verenigde Staten, 94535
- General Robert Huyser Cancer Center at David Grant Medical Center
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Colorado
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Denver, Colorado, Verenigde Staten, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Verenigde Staten, 80218
- Children's Hospital Cancer Center
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Connecticut
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Farmington, Connecticut, Verenigde Staten, 06360-7106
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
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New Haven, Connecticut, Verenigde Staten, 06520-8064
- Yale Comprehensive Cancer Center at Yale University School of Medicine
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Delaware
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Wilmington, Delaware, Verenigde Staten, 19899
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Verenigde Staten, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Verenigde Staten, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Verenigde Staten, 33908
- Children's Hospital of Southwest Florida
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Gainesville, Florida, Verenigde Staten, 32610-0296
- University of Florida Shands Cancer Center
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Hollywood, Florida, Verenigde Staten, 33021
- Joe DiMaggio Children's Hospital at Memorial
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Jacksonville, Florida, Verenigde Staten, 32207
- Nemours Children's Clinic
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Miami, Florida, Verenigde Staten, 33155
- Miami Children's Hospital
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Miami, Florida, Verenigde Staten, 33136
- Jackson Memorial Hospital
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Miami, Florida, Verenigde Staten, 33176-2197
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Verenigde Staten, 32804
- Florida Hospital Cancer Institute
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Orlando, Florida, Verenigde Staten, 32806
- Nemours Children's Clinic - Orlando
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Pensacola, Florida, Verenigde Staten, 32504
- Sacred Heart Children's Hospital
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St. Petersburg, Florida, Verenigde Staten, 33701
- All Children's Hospital
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Tampa, Florida, Verenigde Staten, 33677-4227
- St. Joseph's Children's Hospital of Tampa
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West Palm Beach, Florida, Verenigde Staten, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
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Augusta, Georgia, Verenigde Staten, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
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Macon, Georgia, Verenigde Staten, 31201
- Medical Center of Central Georgia
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Savannah, Georgia, Verenigde Staten, 31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Verenigde Staten, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96813
- MBCCOP - Hawaii
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Idaho
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Boise, Idaho, Verenigde Staten, 83712
- St. Luke's Mountain States Tumor Institute - Boise
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- Rush University Medical Center
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Chicago, Illinois, Verenigde Staten, 60614
- Children's Memorial Hospital - Chicago
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Chicago, Illinois, Verenigde Staten, 60601
- University of Chicago Cancer Research Center
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Chicago, Illinois, Verenigde Staten, 60612
- University of Illinois at Chicago Cancer Center
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Oak Lawn, Illinois, Verenigde Staten, 60453
- Advocate Hope Children's Hospital
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Park Ridge, Illinois, Verenigde Staten, 60068-1174
- Lutheran General Cancer Care Center
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Peoria, Illinois, Verenigde Staten, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Verenigde Staten, 62794-9658
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46260
- St. Vincent Indianapolis Hospital
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Indianapolis, Indiana, Verenigde Staten, 46202-5225
- Riley's Children Cancer Center at Riley Hospital for Children
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Iowa
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Des Moines, Iowa, Verenigde Staten, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50308
- Blank Children's Hospital
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Iowa City, Iowa, Verenigde Staten, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Wichita, Kansas, Verenigde Staten, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40536-0284
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisville, Kentucky, Verenigde Staten, 40202-3830
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Verenigde Staten, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Verenigde Staten, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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New Orleans, Louisiana, Verenigde Staten, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Bangor, Maine, Verenigde Staten, 04401
- Pediatric Specialty Clinic at Eastern Maine Medical Center
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Scarborough, Maine, Verenigde Staten, 04074-9308
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Baltimore, Maryland, Verenigde Staten, 21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Verenigde Staten, 21231-7223
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Silver Spring, Maryland, Verenigde Staten, 20910
- Walter Reed Army Medical Center
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Verenigde Staten, 02111
- Floating Hospital for Children
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Springfield, Massachusetts, Verenigde Staten, 01107
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
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Worcester, Massachusetts, Verenigde Staten, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109-0914
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Verenigde Staten, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Verenigde Staten, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Flint, Michigan, Verenigde Staten, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Verenigde Staten, 49503
- DeVos Children's Hospital
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Kalamazoo, Michigan, Verenigde Staten, 49007-5364
- Bronson Methodist Hospital
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Lansing, Michigan, Verenigde Staten, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Royal Oak, Michigan, Verenigde Staten, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Verenigde Staten, 48073-6769
- William Beaumont Hospital - Royal Oak Campus
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Minnesota
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Duluth, Minnesota, Verenigde Staten, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Minneapolis, Minnesota, Verenigde Staten, 55404
- Children's Hospitals and Clinics - Minneapolis/St. Paul
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, Verenigde Staten, 65203
- University of Missouri - Columbia
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Kansas City, Missouri, Verenigde Staten, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Verenigde Staten, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, Verenigde Staten, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68114
- Children's Hospital of Omaha
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Omaha, Nebraska, Verenigde Staten, 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, Verenigde Staten, 89109
- Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Verenigde Staten, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, Verenigde Staten, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Verenigde Staten, 07112-2094
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Verenigde Staten, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, Verenigde Staten, 07901
- Valerie Fund Children's Center at Atlantic Health
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87131
- University of New Mexico Cancer Research and Treatment Center
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New York
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Albany, New York, Verenigde Staten, 12208
- Children's Hospital at Albany Medical Center
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Bronx, New York, Verenigde Staten, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Verenigde Staten, 11219
- Maimonides Medical Center
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Brooklyn, New York, Verenigde Staten, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, Verenigde Staten, 11212
- Brookdale University Hospital and Medical Center
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Brooklyn, New York, Verenigde Staten, 11201-5493
- Brooklyn Hospital Center
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Buffalo, New York, Verenigde Staten, 14263-0001
- Roswell Park Cancer Institute
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New Hyde Park, New York, Verenigde Staten, 11040
- Schneider Children's Hospital
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New York, New York, Verenigde Staten, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Verenigde Staten, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Verenigde Staten, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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New York, New York, Verenigde Staten, 10029
- Mount Sinai Medical Center
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Rochester, New York, Verenigde Staten, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Verenigde Staten, 11794-8174
- Long Island Cancer Center at Stony Brook University Hospital
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Syracuse, New York, Verenigde Staten, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Verenigde Staten, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Verenigde Staten, 28801
- Mission Hospitals - Memorial Campus
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Chapel Hill, North Carolina, Verenigde Staten, 27599
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, Verenigde Staten, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Verenigde Staten, 28233
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Verenigde Staten, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Verenigde Staten, 27858-4354
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
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Winston-Salem, North Carolina, Verenigde Staten, 27157-1081
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, Verenigde Staten, 58103-4940
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
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Ohio
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Akron, Ohio, Verenigde Staten, 44308-1062
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Verenigde Staten, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Verenigde Staten, 44106-5065
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, Verenigde Staten, 43205-2696
- Columbus Children's Hospital
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Dayton, Ohio, Verenigde Staten, 45404
- Children's Medical Center - Dayton
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Toledo, Ohio, Verenigde Staten, 43601
- Toledo Children's Hospital
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Toledo, Ohio, Verenigde Staten, 43608
- St. Vincent Mercy Medical Center
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Youngstown, Ohio, Verenigde Staten, 44501
- Tod Children's Hospital - Forum Health
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- Children's Hospital at Oklahoma University Medical Center
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Tulsa, Oklahoma, Verenigde Staten, 74136
- CCOP - Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Oregon
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Portland, Oregon, Verenigde Staten, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Verenigde Staten, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
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Portland, Oregon, Verenigde Staten, 97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
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Pennsylvania
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Danville, Pennsylvania, Verenigde Staten, 17822-1320
- Geisinger Medical Center
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Hershey, Pennsylvania, Verenigde Staten, 17033
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Verenigde Staten, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29425-0721
- Hollings Cancer Center at Medical University of South Carolina
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Columbia, South Carolina, Verenigde Staten, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, Verenigde Staten, 29605
- Children's Hospital of Greenville Hospital System
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South Dakota
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Sioux Falls, South Dakota, Verenigde Staten, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
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Sioux Falls, South Dakota, Verenigde Staten, 57105-1080
- Avera Cancer Institute
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Tennessee
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Johnson City, Tennessee, Verenigde Staten, 37614-0622
- East Tennessee State University Cancer Center at Johnson City Medical Center
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Knoxville, Tennessee, Verenigde Staten, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Verenigde Staten, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Verenigde Staten, 37232-6310
- Vanderbilt Children's Hospital
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Texas
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Amarillo, Texas, Verenigde Staten, 79106
- Texas Tech University Health Sciences Center School of Medicine
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Austin, Texas, Verenigde Staten, 78701
- Children's Hospital of Austin
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Dallas, Texas, Verenigde Staten, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Verenigde Staten, 75390-9063
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Verenigde Staten, 76104
- Cook Children's Medical Center - Fort Worth
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Galveston, Texas, Verenigde Staten, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Verenigde Staten, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
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Houston, Texas, Verenigde Staten, 77030
- Cancer Center at Baylor College of Medicine
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Lackland Air Force Base, Texas, Verenigde Staten, 78236-5300
- Wilford Hall Medical Center
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Lubbock, Texas, Verenigde Staten, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Verenigde Staten, 78207
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Verenigde Staten, 78229-3900
- MBCCOP - South Texas Pediatrics
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San Antonio, Texas, Verenigde Staten, 78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
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Temple, Texas, Verenigde Staten, 76508
- CCOP - Scott and White Hospital
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Temple, Texas, Verenigde Staten, 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, Verenigde Staten, 84112
- Huntsman Cancer Institute at University of Utah
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Vermont
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Burlington, Vermont, Verenigde Staten, 05401-3498
- Vermont Cancer Center at University of Vermont
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22908
- University of Virginia Cancer Center
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Falls Church, Virginia, Verenigde Staten, 22042-3300
- INOVA Fairfax Hospital
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Norfolk, Virginia, Verenigde Staten, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, Verenigde Staten, 23708-5100
- Naval Medical Center - Portsmouth
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Richmond, Virginia, Verenigde Staten, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
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Roanoke, Virginia, Verenigde Staten, 24029
- Carilion Medical Center for Children at Roanoke Community Hospital
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Washington
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Seattle, Washington, Verenigde Staten, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Seattle, Washington, Verenigde Staten, 98109-1024
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Verenigde Staten, 98112
- Group Health Central Hospital
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Spokane, Washington, Verenigde Staten, 99210-0248
- Deaconess Medical Center
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Tacoma, Washington, Verenigde Staten, 98415-0299
- Mary Bridge Children's Hospital and Health Center - Tacoma
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Tacoma, Washington, Verenigde Staten, 98431-0001
- Madigan Army Medical Center
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West Virginia
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Charleston, West Virginia, Verenigde Staten, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
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Huntington, West Virginia, Verenigde Staten, 25701
- Cabell Huntington Hospital
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Morgantown, West Virginia, Verenigde Staten, 26506-9300
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Verenigde Staten, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, Verenigde Staten, 54301
- Bellin Memorial Hospital
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Green Bay, Wisconsin, Verenigde Staten, 54307-9070
- St. Vincent Hospital
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La Crosse, Wisconsin, Verenigde Staten, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Verenigde Staten, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, Verenigde Staten, 54449
- CCOP - Marshfield Clinic Research Foundation
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Marshfield, Wisconsin, Verenigde Staten, 54449-5772
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Verenigde Staten, 53226
- Midwest Children's Cancer Center
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Bern, Zwitserland, CH 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Zwitserland, CH 1211
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Zwitserland, CH 1011
- Swiss Pediatric Oncology Group Lausanne
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Niet ouder dan 20 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Behandeling
Zie gedetailleerde beschrijving.
|
Andere namen:
Andere namen:
Andere namen:
Andere namen:
Andere namen:
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Evenement gratis overleven
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: David L. Baker, MD, MBBS, FRACP, FRCPA, Princess Margaret Hospital for Children
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 1988
Primaire voltooiing (Werkelijk)
1 september 2006
Studie voltooiing (Werkelijk)
1 januari 2011
Studieregistratiedata
Eerst ingediend
1 november 1999
Eerst ingediend dat voldeed aan de QC-criteria
26 januari 2003
Eerst geplaatst (Schatting)
27 januari 2003
Updates van studierecords
Laatste update geplaatst (Schatting)
1 augustus 2014
Laatste update ingediend die voldeed aan QC-criteria
31 juli 2014
Laatst geverifieerd
1 juli 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata, glandulair en epitheel
- Neoplasmata, neuro-epitheliaal
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Neuro-ectodermale tumoren, primitief
- Neuro-ectodermale tumoren, primitief, perifeer
- Neuroblastoom
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antireumatische middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Antineoplastische middelen, fytogeen
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Adjuvantia, immunologisch
- Antibiotica, antineoplastiek
- Cyclofosfamide
- Carboplatine
- Etoposide
- Lenograstim
- Doxorubicine
- Liposomale doxorubicine
- Sargramostim
- Molgramostim
Andere studie-ID-nummers
- A3961
- COG-A3961 (Andere identificatie: Children's Oncology Group)
- CCG-A3961 (Andere identificatie: Children's Cancer Group)
- POG-A3961 (Andere identificatie: Pediatric Oncology Group)
- CDR0000065804 (Andere identificatie: Clinical Trials.gov)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .