Surgery in Treating Children With Neuroblastoma
9. marts 2017 opdateret af: 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.
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
968
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Randwick, New South Wales, Australien, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Australien, 2145
- Children's Hospital at Westmead
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Queensland
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Brisbane, Queensland, Australien, 4029
- Royal Children's Hospital
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South Australia
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North Adelaide, South Australia, Australien, 5006
- Women's and Children's Hospital
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Victoria
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Parkville, Victoria, Australien, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australien, 6001
- Princess Margaret Hospital for Children
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Alberta
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Calgary, Alberta, Canada, T2T 5C7
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
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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, 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, H3T 1C5
- Hôpital Sainte Justine
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Montreal, Quebec, Canada, H3G 1A4
- Montreal Children's Hospital at McGill University Health Center
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Sainte Foy, Quebec, Canada, GIV 4G2
- Centre de Recherche du Centre Hospitalier de l'Universite Laval
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, Forenede Stater, 36604
- University of South Alabama Cancer Research Institute
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Arizona
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Phoenix, Arizona, Forenede Stater, 85016
- Phoenix Children's Hospital
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Forenede Stater, 90242
- Southern California Permanente Medical Group
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Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, Forenede Stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Forenede Stater, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Forenede Stater, 90048
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forenede Stater, 90027-0700
- Children's Hospital Los Angeles
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Madera, California, Forenede Stater, 93638-8762
- Children's Hospital Central California
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Oakland, California, Forenede Stater, 94609-1809
- Children's Hospital and Research Center at Oakland
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Orange, California, Forenede Stater, 92868
- Children's Hospital of Orange County
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Orange, California, Forenede Stater, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
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Palo Alto, California, Forenede Stater, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Forenede Stater, 95816
- Sutter Cancer Center
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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Sacramento, California, Forenede Stater, 95825
- Kaiser Permanente Medical Center - Sacramento
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San Diego, California, Forenede Stater, 92120
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
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San Diego, California, Forenede Stater, 92123-4282
- Children's Hospital and Health Center, San Diego
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San Francisco, California, Forenede Stater, 94143
- UCSF Comprehensive Cancer Center
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Santa Barbara, California, Forenede Stater, 93102
- Santa Barbara Cottage Hospital
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Santa Clara, California, Forenede Stater, 95051-5386
- Kaiser Permanente Medical Center - Santa Clara
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Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Forenede Stater, 80218-1088
- Children's Hospital of Denver
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06360-7106
- University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center
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New Haven, Connecticut, Forenede Stater, 06520-8028
- Yale Comprehensive Cancer Center
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Delaware
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Wilmington, Delaware, Forenede Stater, 19899
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Forenede Stater, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Broward General Medical Center
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Fort Myers, Florida, Forenede Stater, 33908
- Children's Hospital of Southwest Florida
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Gainesville, Florida, Forenede Stater, 32610-0296
- Shands Cancer Center at the University of Florida Health Science Center
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Hollywood, Florida, Forenede Stater, 33021
- Joe DiMaggio Children's Hospital at Memorial
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Jacksonville, Florida, Forenede Stater, 32207
- Nemours Children's Clinic
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Miami, Florida, Forenede Stater, 33155
- Miami Children's Hospital
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Miami, Florida, Forenede Stater, 33136
- Jackson Memorial Hospital
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Miami, Florida, Forenede Stater, 33176-2197
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Forenede Stater, 32804
- Florida Hospital Cancer Institute
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Orlando, Florida, Forenede Stater, 32806
- Nemours Children's Clinic-Orlando
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Pensacola, Florida, Forenede Stater, 32504
- Sacred Heart Children's Hospital
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St. Petersburg, Florida, Forenede Stater, 33701
- All Children's Hospital
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Tampa, Florida, Forenede Stater, 33677-4227
- St. Joseph's Children's Hospital
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West Palm Beach, Florida, Forenede Stater, 33407
- St. Mary's Hospital
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
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Augusta, Georgia, Forenede Stater, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
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Macon, Georgia, Forenede Stater, 31201
- Medical Center of Central Georgia
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Savannah, Georgia, Forenede Stater, 31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Forenede Stater, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- MBCCOP - Hawaii
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Idaho
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Boise, Idaho, Forenede Stater, 83712
- Mountain States Tumor Institute - Boise
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forenede Stater, 60614
- Children's Memorial Hospital - Chicago
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Chicago, Illinois, Forenede Stater, 60601
- University of Chicago Cancer Research Center
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois Medical Center
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Oak Lawn, Illinois, Forenede Stater, 60453
- Advocate Hope Children's Hospital
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Park Ridge, Illinois, Forenede Stater, 60068-1174
- Lutheran General Cancer Care Center
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Peoria, Illinois, Forenede Stater, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Forenede Stater, 62794-9658
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202-5225
- Riley Children Cancer Center at Riley Hospital for Children
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Indianapolis, Indiana, Forenede Stater, 46260
- St. Vincent Hospitals and Health Care Centers
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Iowa
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Des Moines, Iowa, Forenede Stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Forenede Stater, 50308
- Blank Children's Hospital
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Iowa City, Iowa, Forenede Stater, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Wichita, Kansas, Forenede Stater, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0284
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisville, Kentucky, Forenede Stater, 40202-3830
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Clinic Foundation
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New Orleans, Louisiana, Forenede Stater, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, Forenede Stater, 04074-9308
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Forenede Stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Forenede Stater, 21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Forenede Stater, 21225
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Silver Spring, Maryland, Forenede Stater, 20910
- Walter Reed Army Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02111
- Floating Hospital for Children
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Springfield, Massachusetts, Forenede Stater, 01107
- Baystate Regional Cancer Program at Baystate Medical Center
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Worcester, Massachusetts, Forenede Stater, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0914
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forenede Stater, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Detroit, Michigan, Forenede Stater, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Forenede Stater, 49503
- Spectrum Health and DeVos Children's Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007-5364
- Bronson Methodist Hospital
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Lansing, Michigan, Forenede Stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Royal Oak, Michigan, Forenede Stater, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Forenede Stater, 48073-6769
- William Beaumont Hospital - Royal Oak
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Minneapolis, Minnesota, Forenede Stater, 55404
- Children's Hospitals and Clinics - Minneapolis
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Paul, Minnesota, Forenede Stater, 55102
- Children's Hospitals and Clinics - Minnesota
-
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Forenede Stater, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, Forenede Stater, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Children's Hospital of Omaha
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Omaha, Nebraska, Forenede Stater, 68198-2168
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109
- Sunrise Hospital and Medical Center
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Cancer Center at Hackensack University Medical Center
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New Brunswick, New Jersey, Forenede Stater, 08903
- Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
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Newark, New Jersey, Forenede Stater, 07112-2094
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Forenede Stater, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, Forenede Stater, 07901
- Valerie Fund Children's Center at Atlantic Health
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131
- University of New Mexico Cancer Research and Treatment Center
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New York
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Albany, New York, Forenede Stater, 12208
- Cancer Center of Albany Medical Center
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Bronx, New York, Forenede Stater, 10461
- Albert Einstein Clinical Cancer Center
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Brooklyn, New York, Forenede Stater, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, Forenede Stater, 11212
- Brookdale University Hospital and Medical Center
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Brooklyn, New York, Forenede Stater, 11201-5493
- Brooklyn Hospital Center
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Brooklyn, New York, Forenede Stater, 11219
- Comprehensive Cancer Center at Maimonides Medical Center
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New Hyde Park, New York, Forenede Stater, 11042
- Schneider Children's Hospital
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forenede Stater, 10029
- Mount Sinai School of Medicine
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New York, New York, Forenede Stater, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Rochester, New York, Forenede Stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Forenede Stater, 11794
- Long Island Cancer Center at Stony Brook University Hospital
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Forenede Stater, 10595
- New York Medical College
-
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospitals
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Chapel Hill, North Carolina, Forenede Stater, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, Forenede Stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Forenede Stater, 28233
- Presbyterian Healthcare
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Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Forenede Stater, 27858-4354
- Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27157-1081
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58103-4940
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
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Ohio
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Akron, Ohio, Forenede Stater, 44308-1062
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Forenede Stater, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, Forenede Stater, 43205-2696
- Columbus Children's Hospital
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Dayton, Ohio, Forenede Stater, 45404
- Children's Medical Center - Dayton
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Toledo, Ohio, Forenede Stater, 43601
- Toledo Children's Hospital
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Toledo, Ohio, Forenede Stater, 43608
- St. Vincent Mercy Medical Center
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Youngstown, Ohio, Forenede Stater, 44501
- Forum Health-Tod Childrens Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Children's Hospital at Oklahoma University Medical Center
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Tulsa, Oklahoma, Forenede Stater, 74136
- Natalie Warren Bryant Cancer Center
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Tulsa, Oklahoma, Forenede Stater, 74136
- CCOP - Oklahoma
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Oregon
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Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
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Portland, Oregon, Forenede Stater, 97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
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Pennsylvania
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Danville, Pennsylvania, Forenede Stater, 17822-1320
- Geisinger Medical Center
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Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Forenede Stater, 15213-2583
- Children's Hospital of Pittsburgh
-
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
-
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425-0721
- Hollings Cancer Center at Medical University of South Carolina
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Columbia, South Carolina, Forenede Stater, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, Forenede Stater, 29605
- Children's Hospital of Greenville Hospital System
-
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105-1080
- Avera Cancer Institute
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Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sioux Valley Hospital at University of South Dakota Medical Center
-
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Tennessee
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Johnson City, Tennessee, Forenede Stater, 37614-0622
- East Tennessee State University Cancer Center at Johnson City Medical Center
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Knoxville, Tennessee, Forenede Stater, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Forenede Stater, 38105-2794
- St. Jude Children's Research Hospital
-
Nashville, Tennessee, Forenede Stater, 37232-6310
- Vanderbilt Children's Hospital
-
-
Texas
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Amarillo, Texas, Forenede Stater, 79106
- Texas Tech University Health Sciences Center School of Medicine
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Austin, Texas, Forenede Stater, 78701
- Children's Hospital of Austin
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Dallas, Texas, Forenede Stater, 75230
- Medical City Dallas Hospital
-
Dallas, Texas, Forenede Stater, 75390-9063
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center - Fort Worth
-
Galveston, Texas, Forenede Stater, 77555-0361
- University of Texas Medical Branch
-
Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
-
Houston, Texas, Forenede Stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Forenede Stater, 78236
- San Antonio Military Pediatric Cancer and Blood Disorders Center
-
Lubbock, Texas, Forenede Stater, 79410
- Covenant Children's Hospital
-
San Antonio, Texas, Forenede Stater, 78207
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Forenede Stater, 78229-3900
- MBCCOP - South Texas Pediatrics
-
San Antonio, Texas, Forenede Stater, 78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
-
Temple, Texas, Forenede Stater, 76508
- Center for Cancer Prevention and Care at Scott and White Clinic
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute
-
-
Vermont
-
Burlington, Vermont, Forenede Stater, 05401-3498
- Vermont Cancer Center at University of Vermont
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- Cancer Center at the University of Virginia
-
Falls Church, Virginia, Forenede Stater, 22042-3300
- INOVA Fairfax Hospital
-
Norfolk, Virginia, Forenede Stater, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, Forenede Stater, 23708-5100
- Naval Medical Center, Portsmouth
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Richmond, Virginia, Forenede Stater, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
-
Roanoke, Virginia, Forenede Stater, 24029
- Carilion Medical Center for Children
-
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Washington
-
Seattle, Washington, Forenede Stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
-
Seattle, Washington, Forenede Stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forenede Stater, 98112
- Group Health Central Hospital
-
Spokane, Washington, Forenede Stater, 99210-0248
- Deaconess Medical Center
-
Tacoma, Washington, Forenede Stater, 98431-5000
- Madigan Army Medical Center
-
Tacoma, Washington, Forenede Stater, 98415-0299
- Mary Bridge Children's Hospital and Health Center
-
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West Virginia
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Charleston, West Virginia, Forenede Stater, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
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Huntington, West Virginia, Forenede Stater, 25701
- Cabell Huntington Hospital
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Morgantown, West Virginia, Forenede Stater, 26506-9300
- West Virginia University Hospitals
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Wisconsin
-
Green Bay, Wisconsin, Forenede Stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, Forenede Stater, 54301
- Bellin Memorial Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54307-9070
- St. Vincent Hospital
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Forenede Stater, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
-
Marshfield, Wisconsin, Forenede Stater, 54449-5772
- Marshfield Clinic
-
Marshfield, Wisconsin, Forenede Stater, 54449
- CCOP - Marshfield Clinic Research Foundation
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Midwest Children's Cancer Center
-
-
-
-
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Groningen, Holland, 9700 RB
- Academisch Ziekenhuis Groningen
-
-
-
-
-
Auckland, New Zealand
- Starship Children's Health
-
-
-
-
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San Juan, Puerto Rico, 00936-5067
- Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
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Santurce, Puerto Rico, 00912
- San Jorge Childrens Hospital
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-
-
-
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Bern, Schweiz, CH 3010
- Swiss Pediatric Oncology Group Bern
-
Geneva, Schweiz, CH 1211
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Schweiz, CH 1011
- Swiss Pediatric Oncology Group Lausanne
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 21 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Treatment 1 - Asymptomatic - no immediate chemotherapy
|
|
|
Eksperimentel: Symptomatic - immediate chemotherapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
|---|---|
|
Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone
|
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studiestol: Douglas R. Strother, MD, Alberta Children's Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
Studiestart
1. marts 1998
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
1. marts 2006
Studieafslutning (Faktiske)
Studieafslutning
1. marts 2006
Datoer for studieregistrering
Først indsendt
Først indsendt
1. november 1999
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
26. januar 2003
Først opslået (Skøn)
Først opslået
27. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
13. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. marts 2017
Sidst verificeret
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroektodermale tumorer, primitive
- Neuroektodermale tumorer, primitive, perifere
- Neuroblastom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antibiotika, antineoplastisk
- Cyclofosfamid
- Carboplatin
- Etoposid
- Doxorubicin
- Liposomal doxorubicin
- Sargramostim
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- P9641
- COG-P9641 (Anden identifikator: Children's Oncology Group)
- POG-P9641 (Anden identifikator: Pediatric Oncology Group)
- CCG-P9641 (Anden identifikator: Children's Cancer Group)
- CDR0000065874 (Anden identifikator: Clinical Trials.gov)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .