Surgery in Treating Children With Neuroblastoma
9 de marzo de 2017 actualizado por: Children's Oncology Group
Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study
RATIONALE: Surgery alone may be effective in treating children with neuroblastoma.
PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
OBJECTIVES:
- To determine if asymptomatic patients with low-risk neuroblastoma treated with surgery alone will have a 3-year survival rate of 95%.
- Estimate the response and 3-year event-free survival rates of symptomatic patients treated with chemotherapy.
- Estimate the event-free survival and overall survival rates in patients who relapse or progress after initial treatment with surgery alone.
- Determine the acute and chronic toxic effects associated with treating low-risk neuroblastoma with surgery alone or surgery and chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage, MYCN status, age, and histology.
Patients undergo primary tumor resection and biopsy of regional nodes. Patients with at least 50% of the tumor resected are followed monthly for 3 months, every 3 months for 9 months, every 6 months for one year, and then annually thereafter.
Regimen I
- Patients with clinically symptomatic (e.g., respiratory distress, spinal cord compromise with or without neurologic deficit, inferior vena cava compression with renal or bowel ischemia, intractable vomiting due to gastrointestinal obstruction, genitourinary obstruction, or coagulopathy) low-risk neuroblastoma or who have less than 50% of the primary tumor resected receive 4 different courses of chemotherapy.
- Course 1: Patients receive carboplatin IV over 1 hour followed by etoposide IV over 2 hours on day 0 and etoposide only on days 1 and 2.
- Course 2: Patients receive carboplatin IV over 1 hour, cyclophosphamide IV over 1 hour, and doxorubicin IV over 15-60 minutes on day 1.
- Course 3: Patients receive cyclophosphamide IV over 1 hour followed by etoposide IV over 2 hours on day 0 and etoposide only on days 1 and 2.
- Course 4: Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours followed by doxorubicin IV over 15-60 minutes on day 0 and etoposide only on days 1 and 2.
Regimen II
- Patients who progress to or recur with unfavorable biology intermediate-risk disease receive an additional 4 courses of chemotherapy.
- Course 5: Patients receive treatment as in course 3 above.
- Course 6: Patients receive treatment as in course 2 above.
- Course 7: Patients receive treatment as in course 1 above.
- Course 8: Patients receive cyclophosphamide IV over 1 hour followed by doxorubicin IV over 15-60 minutes on day 1.
All infants under 60 days of age receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 to 36 hours after chemotherapy and continuing until blood counts recover.
Courses in both regimens repeat every 3 weeks in the absence of unacceptable toxicity.
Patients at risk for symptomatic spinal cord compression may also receive chemotherapy. Patients experiencing progressive or recurrent disease after observation undergo repeat surgery and/or chemotherapy as above. Patients with clinically symptomatic disease may also undergo radiotherapy if response to chemotherapy is not rapid.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within 4 years.
Tipo de estudio
Intervencionista
Inscripción (Actual)
968
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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, Canadá, T2T 5C7
- Alberta Children's Hospital
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Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canadá, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canadá, L8S 4J9
- McMaster Children's Hospital at Hamilton Health Sciences
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London, Ontario, Canadá, N6C 2V5
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canadá, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canadá, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canadá, H3T 1C5
- Hôpital Sainte Justine
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Montreal, Quebec, Canadá, H3G 1A4
- Montreal Children's Hospital at McGill University Health Center
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Sainte Foy, Quebec, Canadá, GIV 4G2
- Centre de Recherche du Centre Hospitalier de l'Universite Laval
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Saskatchewan
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Regina, Saskatchewan, Canadá, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canadá, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, Estados Unidos, 36604
- University of South Alabama Cancer Research Institute
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016
- Phoenix Children's Hospital
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Tucson, Arizona, Estados Unidos, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Estados Unidos, 90242
- Southern California Permanente Medical Group
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Duarte, California, Estados Unidos, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, Estados Unidos, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Estados Unidos, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
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Los Angeles, California, Estados Unidos, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Estados Unidos, 90027-0700
- Children's Hospital Los Angeles
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Madera, California, Estados Unidos, 93638-8762
- Children's Hospital Central California
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Oakland, California, Estados Unidos, 94609-1809
- Children's Hospital and Research Center at Oakland
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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Orange, California, Estados Unidos, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
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Palo Alto, California, Estados Unidos, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Estados Unidos, 95816
- Sutter Cancer Center
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Cancer Center
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Sacramento, California, Estados Unidos, 95825
- Kaiser Permanente Medical Center - Sacramento
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San Diego, California, Estados Unidos, 92120
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
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San Diego, California, Estados Unidos, 92123-4282
- Children's Hospital and Health Center, San Diego
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San Francisco, California, Estados Unidos, 94143
- UCSF Comprehensive Cancer Center
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Santa Barbara, California, Estados Unidos, 93102
- Santa Barbara Cottage Hospital
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Santa Clara, California, Estados Unidos, 95051-5386
- Kaiser Permanente Medical Center - Santa Clara
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Travis Air Force Base, California, Estados Unidos, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Estados Unidos, 80218-1088
- Children's Hospital of Denver
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Denver, Colorado, Estados Unidos, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06360-7106
- University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center
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New Haven, Connecticut, Estados Unidos, 06520-8028
- Yale Comprehensive Cancer Center
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Delaware
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Wilmington, Delaware, Estados Unidos, 19899
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33316
- Broward General Medical Center
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Fort Myers, Florida, Estados Unidos, 33908
- Children's Hospital of Southwest Florida
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Gainesville, Florida, Estados Unidos, 32610-0296
- Shands Cancer Center at the University of Florida Health Science Center
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Hollywood, Florida, Estados Unidos, 33021
- Joe DiMaggio Children's Hospital at Memorial
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Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic
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Miami, Florida, Estados Unidos, 33155
- Miami Children's Hospital
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Miami, Florida, Estados Unidos, 33136
- Jackson Memorial Hospital
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Miami, Florida, Estados Unidos, 33176-2197
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Estados Unidos, 32804
- Florida Hospital Cancer Institute
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Orlando, Florida, Estados Unidos, 32806
- Nemours Children's Clinic-Orlando
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Pensacola, Florida, Estados Unidos, 32504
- Sacred Heart Children's Hospital
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St. Petersburg, Florida, Estados Unidos, 33701
- All Children's Hospital
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Tampa, Florida, Estados Unidos, 33677-4227
- St. Joseph's Children's Hospital
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West Palm Beach, Florida, Estados Unidos, 33407
- St. Mary's Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
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Augusta, Georgia, Estados Unidos, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
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Macon, Georgia, Estados Unidos, 31201
- Medical Center of Central Georgia
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Savannah, Georgia, Estados Unidos, 31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Estados Unidos, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- MBCCOP - Hawaii
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Idaho
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Boise, Idaho, Estados Unidos, 83712
- Mountain States Tumor Institute - Boise
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Chicago, Illinois, Estados Unidos, 60614
- Children's Memorial Hospital - Chicago
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Chicago, Illinois, Estados Unidos, 60601
- University of Chicago Cancer Research Center
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois Medical Center
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Oak Lawn, Illinois, Estados Unidos, 60453
- Advocate Hope Children's Hospital
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Park Ridge, Illinois, Estados Unidos, 60068-1174
- Lutheran General Cancer Care Center
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Peoria, Illinois, Estados Unidos, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Estados Unidos, 62794-9658
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5225
- Riley Children Cancer Center at Riley Hospital for Children
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Indianapolis, Indiana, Estados Unidos, 46260
- St. Vincent Hospitals and Health Care Centers
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Iowa
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Des Moines, Iowa, Estados Unidos, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Estados Unidos, 50308
- Blank Children's Hospital
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Iowa City, Iowa, Estados Unidos, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Wichita, Kansas, Estados Unidos, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0284
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisville, Kentucky, Estados Unidos, 40202-3830
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Clinic Foundation
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New Orleans, Louisiana, Estados Unidos, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Estados Unidos, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Bangor, Maine, Estados Unidos, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, Estados Unidos, 04074-9308
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Estados Unidos, 21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Estados Unidos, 21225
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Silver Spring, Maryland, Estados Unidos, 20910
- Walter Reed Army Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02111
- Floating Hospital for Children
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Springfield, Massachusetts, Estados Unidos, 01107
- Baystate Regional Cancer Program at Baystate Medical Center
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Worcester, Massachusetts, Estados Unidos, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-0914
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Estados Unidos, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Estados Unidos, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Detroit, Michigan, Estados Unidos, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Estados Unidos, 49503
- Spectrum Health and DeVos Children's Hospital
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Kalamazoo, Michigan, Estados Unidos, 49007-5364
- Bronson Methodist Hospital
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Lansing, Michigan, Estados Unidos, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Royal Oak, Michigan, Estados Unidos, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Estados Unidos, 48073-6769
- William Beaumont Hospital - Royal Oak
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Minneapolis, Minnesota, Estados Unidos, 55404
- Children's Hospitals and Clinics - Minneapolis
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Paul, Minnesota, Estados Unidos, 55102
- Children's Hospitals and Clinics - Minnesota
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Estados Unidos, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, Estados Unidos, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68114
- Children's Hospital of Omaha
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Omaha, Nebraska, Estados Unidos, 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, Estados Unidos, 89109
- Sunrise Hospital and Medical Center
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Cancer Center at Hackensack University Medical Center
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New Brunswick, New Jersey, Estados Unidos, 08903
- Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
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Newark, New Jersey, Estados Unidos, 07112-2094
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Estados Unidos, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, Estados Unidos, 07901
- Valerie Fund Children's Center at Atlantic Health
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131
- University of New Mexico Cancer Research and Treatment Center
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New York
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Albany, New York, Estados Unidos, 12208
- Cancer Center of Albany Medical Center
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Bronx, New York, Estados Unidos, 10461
- Albert Einstein Clinical Cancer Center
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Brooklyn, New York, Estados Unidos, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, Estados Unidos, 11212
- Brookdale University Hospital and Medical Center
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Brooklyn, New York, Estados Unidos, 11201-5493
- Brooklyn Hospital Center
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Brooklyn, New York, Estados Unidos, 11219
- Comprehensive Cancer Center at Maimonides Medical Center
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New Hyde Park, New York, Estados Unidos, 11042
- Schneider Children's Hospital
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Estados Unidos, 10029
- Mount Sinai School of Medicine
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New York, New York, Estados Unidos, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Rochester, New York, Estados Unidos, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Estados Unidos, 11794
- Long Island Cancer Center at Stony Brook University Hospital
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Estados Unidos, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28801
- Mission Hospitals
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, Estados Unidos, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Estados Unidos, 28233
- Presbyterian Healthcare
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Estados Unidos, 27858-4354
- Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157-1081
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58103-4940
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
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Ohio
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Akron, Ohio, Estados Unidos, 44308-1062
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Estados Unidos, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106-5065
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, Estados Unidos, 43205-2696
- Columbus Children's Hospital
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Dayton, Ohio, Estados Unidos, 45404
- Children's Medical Center - Dayton
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Toledo, Ohio, Estados Unidos, 43601
- Toledo Children's Hospital
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Toledo, Ohio, Estados Unidos, 43608
- St. Vincent Mercy Medical Center
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Youngstown, Ohio, Estados Unidos, 44501
- Forum Health-Tod Childrens Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Children's Hospital at Oklahoma University Medical Center
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Tulsa, Oklahoma, Estados Unidos, 74136
- Natalie Warren Bryant Cancer Center
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Tulsa, Oklahoma, Estados Unidos, 74136
- CCOP - Oklahoma
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Oregon
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Portland, Oregon, Estados Unidos, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Estados Unidos, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
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Portland, Oregon, Estados Unidos, 97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
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Pennsylvania
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Danville, Pennsylvania, Estados Unidos, 17822-1320
- Geisinger Medical Center
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Estados Unidos, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Estados Unidos, 15213-2583
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425-0721
- Hollings Cancer Center at Medical University of South Carolina
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Columbia, South Carolina, Estados Unidos, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, Estados Unidos, 29605
- Children's Hospital of Greenville Hospital System
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105-1080
- Avera Cancer Institute
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Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sioux Valley Hospital at University of South Dakota Medical Center
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Tennessee
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Johnson City, Tennessee, Estados Unidos, 37614-0622
- East Tennessee State University Cancer Center at Johnson City Medical Center
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Knoxville, Tennessee, Estados Unidos, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Estados Unidos, 38105-2794
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Estados Unidos, 37232-6310
- Vanderbilt Children's Hospital
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Texas Tech University Health Sciences Center School of Medicine
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Austin, Texas, Estados Unidos, 78701
- Children's Hospital of Austin
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Dallas, Texas, Estados Unidos, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Estados Unidos, 75390-9063
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center - Fort Worth
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Galveston, Texas, Estados Unidos, 77555-0361
- University of Texas Medical Branch
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
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Houston, Texas, Estados Unidos, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, Estados Unidos, 78236
- San Antonio Military Pediatric Cancer and Blood Disorders Center
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Lubbock, Texas, Estados Unidos, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Estados Unidos, 78207
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Estados Unidos, 78229-3900
- MBCCOP - South Texas Pediatrics
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San Antonio, Texas, Estados Unidos, 78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
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Temple, Texas, Estados Unidos, 76508
- CCOP - Scott and White Hospital
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Temple, Texas, Estados Unidos, 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, Estados Unidos, 84112
- Huntsman Cancer Institute
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Vermont
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Burlington, Vermont, Estados Unidos, 05401-3498
- Vermont Cancer Center at University of Vermont
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- Cancer Center at the University of Virginia
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Falls Church, Virginia, Estados Unidos, 22042-3300
- INOVA Fairfax Hospital
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Norfolk, Virginia, Estados Unidos, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, Estados Unidos, 23708-5100
- Naval Medical Center, Portsmouth
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Richmond, Virginia, Estados Unidos, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
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Roanoke, Virginia, Estados Unidos, 24029
- Carilion Medical Center for Children
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Seattle, Washington, Estados Unidos, 98109-1024
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Estados Unidos, 98112
- Group Health Central Hospital
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Spokane, Washington, Estados Unidos, 99210-0248
- Deaconess Medical Center
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Tacoma, Washington, Estados Unidos, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Estados Unidos, 98415-0299
- Mary Bridge Children's Hospital and Health Center
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
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Huntington, West Virginia, Estados Unidos, 25701
- Cabell Huntington Hospital
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Morgantown, West Virginia, Estados Unidos, 26506-9300
- West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, Estados Unidos, 54301
- Bellin Memorial Hospital
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Green Bay, Wisconsin, Estados Unidos, 54307-9070
- St. Vincent Hospital
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La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Estados Unidos, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, Estados Unidos, 54449-5772
- Marshfield Clinic
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Marshfield, Wisconsin, Estados Unidos, 54449
- CCOP - Marshfield Clinic Research Foundation
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Midwest Children's Cancer Center
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Auckland, Nueva Zelanda
- Starship Children's Health
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-
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Groningen, Países Bajos, 9700 RB
- Academisch Ziekenhuis Groningen
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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 Childrens Hospital
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Bern, Suiza, CH 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Suiza, CH 1211
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Suiza, CH 1011
- Swiss Pediatric Oncology Group Lausanne
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
No mayor que 21 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
DISEASE CHARACTERISTICS:
Histologically proven low-risk neuroblastoma (excluding ganglioneuroma)
- International Neuroblastoma Staging System (INSS) stage 1 in all patients
- INSS stage 2A or 2B in patients less than 365 days of age
- INSS stage 2A or 2B tumor with nonamplified MYCN with any Shimada histology in patients ages 1 to 20 years
- INSS stage 2A or 2B tumor with amplified MYCN with Shimada favorable histology in patients ages 1 to 20 years
- INSS stage 4S tumors with nonamplified MYCN, Shimada favorable histology, and a DNA index not equal to 1 in patients less than 365 days of age
Immediate chemotherapy allowed prior to biopsy for patients with intradural extension and/or emergent paresis if biopsy performed within 96 hours
- Must have no abnormal organ function unless due to neuroblastoma
- Concurrent registration on companion biology study (protocol COG-ANBL00B1) or its successor
PATIENT CHARACTERISTICS:
Age:
- Under 21
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 1.5 times normal
- SGOT or SGPT less than 2.5 times normal
Renal:
- Creatinine less than 1.5 times normal
Cardiovascular:
- Shortening fraction greater than 27% by echocardiogram OR
- Ejection fraction greater than 47% by radionuclide angiogram
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- No prior hormonal therapy
Radiotherapy:
- No prior radiotherapy
Surgery:
- Prior surgery allowed
Other:
- No other prior therapy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Treatment 1 - Asymptomatic - no immediate chemotherapy
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Experimental: Symptomatic - immediate chemotherapy
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
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Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone
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The primary objective is to estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone.
Under the assumption that about 90% of the low risk 2A/2B patients will be asymptomatic, and 10% of these will be lost to follow up, the projected sample size will enable estimation of the survival rate with a standard error less than .03.
This sample size will also provide sufficient power for the sequential monitoring plan (see below) for this subgroup of patients.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Douglas R. Strother, MD, Alberta Children's Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- Strother DR, London WB, Schmidt ML, Brodeur GM, Shimada H, Thorner P, Collins MH, Tagge E, Adkins S, Reynolds CP, Murray K, Lavey RS, Matthay KK, Castleberry R, Maris JM, Cohn SL. Outcome after surgery alone or with restricted use of chemotherapy for patients with low-risk neuroblastoma: results of Children's Oncology Group study P9641. J Clin Oncol. 2012 May 20;30(15):1842-8. doi: 10.1200/JCO.2011.37.9990. Epub 2012 Apr 23.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 1998
Finalización primaria (Actual)
1 de marzo de 2006
Finalización del estudio (Actual)
1 de marzo de 2006
Fechas de registro del estudio
Enviado por primera vez
1 de noviembre de 1999
Primero enviado que cumplió con los criterios de control de calidad
26 de enero de 2003
Publicado por primera vez (Estimar)
27 de enero de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de marzo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
9 de marzo de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias Glandulares y Epiteliales
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Tumores Neuroectodérmicos Primitivos
- Tumores Neuroectodérmicos Primitivos Periféricos
- Neuroblastoma
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antirreumáticos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Antibióticos, Antineoplásicos
- Ciclofosfamida
- Carboplatino
- Etopósido
- Doxorrubicina
- Doxorrubicina liposomal
- Sargramostim
Otros números de identificación del estudio
- P9641
- COG-P9641 (Otro identificador: Children's Oncology Group)
- POG-P9641 (Otro identificador: Pediatric Oncology Group)
- CCG-P9641 (Otro identificador: Children's Cancer Group)
- CDR0000065874 (Otro identificador: Clinical Trials.gov)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .