Surgery in Treating Children With Neuroblastoma
2017년 3월 9일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
중재적
등록 (실제)
968
단계
- 3단계
연락처 및 위치
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연구 장소
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Groningen, 네덜란드, 9700 RB
- Academisch Ziekenhuis Groningen
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Auckland, 뉴질랜드
- Starship Children's Health
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Alabama
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Birmingham, Alabama, 미국, 35233
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, 미국, 36604
- University of South Alabama Cancer Research Institute
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Arizona
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Phoenix, Arizona, 미국, 85016
- Phoenix Children's Hospital
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Tucson, Arizona, 미국, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, 미국, 90242
- Southern California Permanente Medical Group
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Duarte, California, 미국, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, 미국, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Loma Linda, California, 미국, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, 미국, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, 미국, 90048
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
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Los Angeles, California, 미국, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, 미국, 90027-0700
- Children's Hospital Los Angeles
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Madera, California, 미국, 93638-8762
- Children's Hospital Central California
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Oakland, California, 미국, 94609-1809
- Children's Hospital and Research Center at Oakland
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Orange, California, 미국, 92868
- Children's Hospital of Orange County
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Orange, California, 미국, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
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Palo Alto, California, 미국, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, 미국, 95816
- Sutter Cancer Center
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Sacramento, California, 미국, 95817
- University of California Davis Cancer Center
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Sacramento, California, 미국, 95825
- Kaiser Permanente Medical Center - Sacramento
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San Diego, California, 미국, 92120
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
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San Diego, California, 미국, 92123-4282
- Children's Hospital and Health Center, San Diego
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San Francisco, California, 미국, 94143
- UCSF Comprehensive Cancer Center
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Santa Barbara, California, 미국, 93102
- Santa Barbara Cottage Hospital
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Santa Clara, California, 미국, 95051-5386
- Kaiser Permanente Medical Center - Santa Clara
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Travis Air Force Base, California, 미국, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, 미국, 80218-1088
- Children's Hospital of Denver
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Denver, Colorado, 미국, 80218
- Presbyterian - St. Luke's Medical Center
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Connecticut
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Farmington, Connecticut, 미국, 06360-7106
- University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center
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New Haven, Connecticut, 미국, 06520-8028
- Yale Comprehensive Cancer Center
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Delaware
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Wilmington, Delaware, 미국, 19899
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, 미국, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, 미국, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, 미국, 33316
- Broward General Medical Center
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Fort Myers, Florida, 미국, 33908
- Children's Hospital of Southwest Florida
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Gainesville, Florida, 미국, 32610-0296
- Shands Cancer Center at the University of Florida Health Science Center
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Hollywood, Florida, 미국, 33021
- Joe DiMaggio Children's Hospital at Memorial
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Jacksonville, Florida, 미국, 32207
- Nemours Children's Clinic
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Miami, Florida, 미국, 33155
- Miami Children's Hospital
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Miami, Florida, 미국, 33136
- Jackson Memorial Hospital
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Miami, Florida, 미국, 33176-2197
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, 미국, 32804
- Florida Hospital Cancer Institute
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Orlando, Florida, 미국, 32806
- Nemours Children's Clinic-Orlando
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Pensacola, Florida, 미국, 32504
- Sacred Heart Children's Hospital
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St. Petersburg, Florida, 미국, 33701
- All Children's Hospital
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Tampa, Florida, 미국, 33677-4227
- St. Joseph's Children's Hospital
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West Palm Beach, Florida, 미국, 33407
- St. Mary's Hospital
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Georgia
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Atlanta, Georgia, 미국, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
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Augusta, Georgia, 미국, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
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Macon, Georgia, 미국, 31201
- Medical Center of Central Georgia
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Savannah, Georgia, 미국, 31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, 미국, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, 미국, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, 미국, 96813
- MBCCOP - Hawaii
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Idaho
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Boise, Idaho, 미국, 83712
- Mountain States Tumor Institute - Boise
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Illinois
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Chicago, Illinois, 미국, 60612
- Rush University Medical Center
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Chicago, Illinois, 미국, 60614
- Children's Memorial Hospital - Chicago
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Chicago, Illinois, 미국, 60601
- University of Chicago Cancer Research Center
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Chicago, Illinois, 미국, 60612
- University of Illinois Medical Center
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Oak Lawn, Illinois, 미국, 60453
- Advocate Hope Children's Hospital
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Park Ridge, Illinois, 미국, 60068-1174
- Lutheran General Cancer Care Center
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Peoria, Illinois, 미국, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, 미국, 62794-9658
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, 미국, 46202-5225
- Riley Children Cancer Center at Riley Hospital for Children
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Indianapolis, Indiana, 미국, 46260
- St. Vincent Hospitals and Health Care Centers
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Iowa
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Des Moines, Iowa, 미국, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, 미국, 50308
- Blank Children's Hospital
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Iowa City, Iowa, 미국, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Wichita, Kansas, 미국, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, 미국, 40536-0284
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisville, Kentucky, 미국, 40202-3830
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, 미국, 70121
- Ochsner Clinic Foundation
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New Orleans, Louisiana, 미국, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, 미국, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, 미국, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Bangor, Maine, 미국, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, 미국, 04074-9308
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, 미국, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, 미국, 21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, 미국, 21225
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Silver Spring, Maryland, 미국, 20910
- Walter Reed Army Medical Center
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, 미국, 02111
- Floating Hospital for Children
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Springfield, Massachusetts, 미국, 01107
- Baystate Regional Cancer Program at Baystate Medical Center
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Worcester, Massachusetts, 미국, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, 미국, 48109-0914
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, 미국, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, 미국, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Detroit, Michigan, 미국, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Flint, Michigan, 미국, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, 미국, 49503
- Spectrum Health and DeVos Children's Hospital
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Kalamazoo, Michigan, 미국, 49007-5364
- Bronson Methodist Hospital
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Lansing, Michigan, 미국, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Royal Oak, Michigan, 미국, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, 미국, 48073-6769
- William Beaumont Hospital - Royal Oak
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Minnesota
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Duluth, Minnesota, 미국, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Minneapolis, Minnesota, 미국, 55404
- Children's Hospitals and Clinics - Minneapolis
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
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Saint Paul, Minnesota, 미국, 55102
- Children's Hospitals and Clinics - Minnesota
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Mississippi
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Jackson, Mississippi, 미국, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, 미국, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, 미국, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, 미국, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, 미국, 68114
- Children's Hospital of Omaha
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Omaha, Nebraska, 미국, 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, 미국, 89109
- Sunrise Hospital and Medical Center
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Cancer Center at Hackensack University Medical Center
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New Brunswick, New Jersey, 미국, 08903
- Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
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Newark, New Jersey, 미국, 07112-2094
- Newark Beth Israel Medical Center
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Paterson, New Jersey, 미국, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, 미국, 07901
- Valerie Fund Children's Center at Atlantic Health
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New Mexico
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Albuquerque, New Mexico, 미국, 87131
- University of New Mexico Cancer Research and Treatment Center
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New York
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Albany, New York, 미국, 12208
- Cancer Center of Albany Medical Center
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Bronx, New York, 미국, 10461
- Albert Einstein Clinical Cancer Center
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Brooklyn, New York, 미국, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, 미국, 11212
- Brookdale University Hospital and Medical Center
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Brooklyn, New York, 미국, 11201-5493
- Brooklyn Hospital Center
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Brooklyn, New York, 미국, 11219
- Comprehensive Cancer Center at Maimonides Medical Center
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New Hyde Park, New York, 미국, 11042
- Schneider Children's Hospital
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New York, New York, 미국, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, 미국, 10029
- Mount Sinai School of Medicine
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New York, New York, 미국, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, 미국, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Rochester, New York, 미국, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, 미국, 11794
- Long Island Cancer Center at Stony Brook University Hospital
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Syracuse, New York, 미국, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, 미국, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, 미국, 28801
- Mission Hospitals
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Chapel Hill, North Carolina, 미국, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, 미국, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, 미국, 28233
- Presbyterian Healthcare
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, 미국, 27858-4354
- Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
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Winston-Salem, North Carolina, 미국, 27157-1081
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, 미국, 58103-4940
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
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Ohio
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Akron, Ohio, 미국, 44308-1062
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, 미국, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, 미국, 44106-5065
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, 미국, 43205-2696
- Columbus Children's Hospital
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Dayton, Ohio, 미국, 45404
- Children's Medical Center - Dayton
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Toledo, Ohio, 미국, 43601
- Toledo Children's Hospital
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Toledo, Ohio, 미국, 43608
- St. Vincent Mercy Medical Center
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Youngstown, Ohio, 미국, 44501
- Forum Health-Tod Childrens Hospital
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Children's Hospital at Oklahoma University Medical Center
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Tulsa, Oklahoma, 미국, 74136
- Natalie Warren Bryant Cancer Center
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Tulsa, Oklahoma, 미국, 74136
- CCOP - Oklahoma
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Oregon
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Portland, Oregon, 미국, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, 미국, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
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Portland, Oregon, 미국, 97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
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Pennsylvania
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Danville, Pennsylvania, 미국, 17822-1320
- Geisinger Medical Center
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Hershey, Pennsylvania, 미국, 17033
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, 미국, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, 미국, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, 미국, 15213-2583
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, 미국, 29425-0721
- Hollings Cancer Center at Medical University of South Carolina
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Columbia, South Carolina, 미국, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, 미국, 29605
- Children's Hospital of Greenville Hospital System
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South Dakota
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Sioux Falls, South Dakota, 미국, 57105-1080
- Avera Cancer Institute
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Sioux Falls, South Dakota, 미국, 57117-5039
- Sioux Valley Hospital at University of South Dakota Medical Center
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Tennessee
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Johnson City, Tennessee, 미국, 37614-0622
- East Tennessee State University Cancer Center at Johnson City Medical Center
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Knoxville, Tennessee, 미국, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, 미국, 38105-2794
- St. Jude Children's Research Hospital
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Nashville, Tennessee, 미국, 37232-6310
- Vanderbilt Children's Hospital
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Texas
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Amarillo, Texas, 미국, 79106
- Texas Tech University Health Sciences Center School of Medicine
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Austin, Texas, 미국, 78701
- Children's Hospital of Austin
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Dallas, Texas, 미국, 75230
- Medical City Dallas Hospital
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Dallas, Texas, 미국, 75390-9063
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, 미국, 76104
- Cook Children's Medical Center - Fort Worth
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Galveston, Texas, 미국, 77555-0361
- University of Texas Medical Branch
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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Houston, Texas, 미국, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, 미국, 78236
- San Antonio Military Pediatric Cancer and Blood Disorders Center
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Lubbock, Texas, 미국, 79410
- Covenant Children's Hospital
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San Antonio, Texas, 미국, 78207
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, 미국, 78229-3900
- MBCCOP - South Texas Pediatrics
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San Antonio, Texas, 미국, 78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
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Temple, Texas, 미국, 76508
- CCOP - Scott and White Hospital
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Temple, Texas, 미국, 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, 미국, 84112
- Huntsman Cancer Institute
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Vermont
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Burlington, Vermont, 미국, 05401-3498
- Vermont Cancer Center at University of Vermont
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Virginia
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Charlottesville, Virginia, 미국, 22908
- Cancer Center at the University of Virginia
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Falls Church, Virginia, 미국, 22042-3300
- INOVA Fairfax Hospital
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Norfolk, Virginia, 미국, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, 미국, 23708-5100
- Naval Medical Center, Portsmouth
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Richmond, Virginia, 미국, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
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Roanoke, Virginia, 미국, 24029
- Carilion Medical Center for Children
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Washington
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Seattle, Washington, 미국, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Seattle, Washington, 미국, 98109-1024
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, 미국, 98112
- Group Health Central Hospital
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Spokane, Washington, 미국, 99210-0248
- Deaconess Medical Center
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Tacoma, Washington, 미국, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, 미국, 98415-0299
- Mary Bridge Children's Hospital and Health Center
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West Virginia
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Charleston, West Virginia, 미국, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
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Huntington, West Virginia, 미국, 25701
- Cabell Huntington Hospital
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Morgantown, West Virginia, 미국, 26506-9300
- West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, 미국, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, 미국, 54301
- Bellin Memorial Hospital
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Green Bay, Wisconsin, 미국, 54307-9070
- St. Vincent Hospital
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La Crosse, Wisconsin, 미국, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, 미국, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, 미국, 54449-5772
- Marshfield Clinic
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Marshfield, Wisconsin, 미국, 54449
- CCOP - Marshfield Clinic Research Foundation
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Milwaukee, Wisconsin, 미국, 53226
- Midwest Children's Cancer Center
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Bern, 스위스, CH 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, 스위스, CH 1211
- Swiss Pediatric Oncology Group Geneva
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Lausanne, 스위스, CH 1011
- Swiss Pediatric Oncology Group Lausanne
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-
-
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Alberta
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Calgary, Alberta, 캐나다, T2T 5C7
- Alberta Children's Hospital
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Edmonton, Alberta, 캐나다, T6G 1Z2
- Cross Cancer Institute
-
-
British Columbia
-
Vancouver, British Columbia, 캐나다, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3E 0V9
- CancerCare Manitoba
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-
Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, 캐나다, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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-
Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, 캐나다, L8S 4J9
- McMaster Children's Hospital at Hamilton Health Sciences
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London, Ontario, 캐나다, N6C 2V5
- Children's Hospital of Western Ontario
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Ottawa, Ontario, 캐나다, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, 캐나다, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, 캐나다, H3T 1C5
- Hôpital Sainte Justine
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Montreal, Quebec, 캐나다, H3G 1A4
- Montreal Children's Hospital at McGill University Health Center
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Sainte Foy, Quebec, 캐나다, GIV 4G2
- Centre de Recherche du Centre Hospitalier de l'Universite Laval
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Saskatchewan
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Regina, Saskatchewan, 캐나다, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre
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San Juan, 푸에르토 리코, 00936-5067
- Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
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Santurce, 푸에르토 리코, 00912
- San Jorge Childrens Hospital
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-
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New South Wales
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Randwick, New South Wales, 호주, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, 호주, 2145
- Children's Hospital at Westmead
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Queensland
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Brisbane, Queensland, 호주, 4029
- Royal Children's Hospital
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South Australia
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North Adelaide, South Australia, 호주, 5006
- Women's and Children's Hospital
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Victoria
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Parkville, Victoria, 호주, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, 호주, 6001
- Princess Margaret Hospital for Children
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
21년 이하 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treatment 1 - Asymptomatic - no immediate chemotherapy
|
|
|
실험적: Symptomatic - immediate chemotherapy
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
|---|---|
|
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.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Douglas R. Strother, MD, Alberta Children's Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
1998년 3월 1일
기본 완료 (실제)
2006년 3월 1일
연구 완료 (실제)
2006년 3월 1일
연구 등록 날짜
최초 제출
1999년 11월 1일
QC 기준을 충족하는 최초 제출
2003년 1월 26일
처음 게시됨 (추정)
2003년 1월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 3월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 3월 9일
마지막으로 확인됨
2017년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P9641
- COG-P9641 (기타 식별자: Children's Oncology Group)
- POG-P9641 (기타 식별자: Pediatric Oncology Group)
- CCG-P9641 (기타 식별자: Children's Cancer Group)
- CDR0000065874 (기타 식별자: Clinical Trials.gov)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .