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Surgery in Treating Children With Neuroblastoma

9 marca 2017 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Nerwiak zarodkowy : neuroblastoma

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

968

Faza

Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Australia
- New South Wales
  - Randwick, New South Wales, Australia, 2031
    - Sydney Children's Hospital
  - Westmead, New South Wales, Australia, 2145
    - Children's Hospital at Westmead
- Queensland
  - Brisbane, Queensland, Australia, 4029
    - Royal Children's Hospital
- South Australia
  - North Adelaide, South Australia, Australia, 5006
    - Women's and Children's Hospital
- Victoria
  - Parkville, Victoria, Australia, 3052
    - Royal Children's Hospital
- Western Australia
  - Perth, Western Australia, Australia, 6001
    - Princess Margaret Hospital for Children
Holandia
- - Groningen, Holandia, 9700 RB
    - Academisch Ziekenhuis Groningen
Kanada
- Alberta
  - Calgary, Alberta, Kanada, T2T 5C7
    - Alberta Children's Hospital
  - Edmonton, Alberta, Kanada, T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Vancouver, British Columbia, Kanada, V6H 3V4
    - British Columbia Children's Hospital
- Manitoba
  - Winnipeg, Manitoba, Kanada, R3E 0V9
    - CancerCare Manitoba
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
    - Janeway Children's Health and Rehabilitation Centre
- Nova Scotia
  - Halifax, Nova Scotia, Kanada, B3J 3G9
    - IWK Health Centre
- Ontario
  - Hamilton, Ontario, Kanada, L8S 4J9
    - McMaster Children's Hospital at Hamilton Health Sciences
  - London, Ontario, Kanada, N6C 2V5
    - Children's Hospital of Western Ontario
  - Ottawa, Ontario, Kanada, K1H 8L1
    - Children's Hospital of Eastern Ontario
  - Toronto, Ontario, Kanada, M5G 1X8
    - Hospital for Sick Children
- Quebec
  - Montreal, Quebec, Kanada, H3T 1C5
    - Hôpital Sainte Justine
  - Montreal, Quebec, Kanada, H3G 1A4
    - Montreal Children's Hospital at McGill University Health Center
  - Sainte Foy, Quebec, Kanada, GIV 4G2
    - Centre de Recherche du Centre Hospitalier de l'Universite Laval
- Saskatchewan
  - Regina, Saskatchewan, Kanada, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
  - Saskatoon, Saskatchewan, Kanada, S7N 4H4
    - Saskatoon Cancer Centre
Nowa Zelandia
- - Auckland, Nowa Zelandia
    - Starship Children's Health
Portoryko
- - San Juan, Portoryko, 00936-5067
    - Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
  - Santurce, Portoryko, 00912
    - San Jorge Childrens Hospital
Stany Zjednoczone
- Alabama
  - Birmingham, Alabama, Stany Zjednoczone, 35233
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Mobile, Alabama, Stany Zjednoczone, 36604
    - University of South Alabama Cancer Research Institute
- Arizona
  - Phoenix, Arizona, Stany Zjednoczone, 85016
    - Phoenix Children's Hospital
  - Tucson, Arizona, Stany Zjednoczone, 85724
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Little Rock, Arkansas, Stany Zjednoczone, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Downey, California, Stany Zjednoczone, 90242
    - Southern California Permanente Medical Group
  - Duarte, California, Stany Zjednoczone, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - La Jolla, California, Stany Zjednoczone, 92093-0658
    - Rebecca and John Moores UCSD Cancer Center
  - Loma Linda, California, Stany Zjednoczone, 92354
    - Loma Linda University Cancer Institute at Loma Linda University Medical Center
  - Long Beach, California, Stany Zjednoczone, 90801-1428
    - Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  - Los Angeles, California, Stany Zjednoczone, 90048
    - Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
  - Los Angeles, California, Stany Zjednoczone, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, Stany Zjednoczone, 90027-0700
    - Children's Hospital Los Angeles
  - Madera, California, Stany Zjednoczone, 93638-8762
    - Children's Hospital Central California
  - Oakland, California, Stany Zjednoczone, 94609-1809
    - Children's Hospital and Research Center at Oakland
  - Orange, California, Stany Zjednoczone, 92868
    - Children's Hospital of Orange County
  - Orange, California, Stany Zjednoczone, 92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
  - Palo Alto, California, Stany Zjednoczone, 94304
    - Lucile Packard Children's Hospital at Stanford University Medical Center
  - Sacramento, California, Stany Zjednoczone, 95816
    - Sutter Cancer Center
  - Sacramento, California, Stany Zjednoczone, 95817
    - University of California Davis Cancer Center
  - Sacramento, California, Stany Zjednoczone, 95825
    - Kaiser Permanente Medical Center - Sacramento
  - San Diego, California, Stany Zjednoczone, 92120
    - Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
  - San Diego, California, Stany Zjednoczone, 92123-4282
    - Children's Hospital and Health Center, San Diego
  - San Francisco, California, Stany Zjednoczone, 94143
    - UCSF Comprehensive Cancer Center
  - Santa Barbara, California, Stany Zjednoczone, 93102
    - Santa Barbara Cottage Hospital
  - Santa Clara, California, Stany Zjednoczone, 95051-5386
    - Kaiser Permanente Medical Center - Santa Clara
  - Travis Air Force Base, California, Stany Zjednoczone, 94535
    - David Grant Medical Center
- Colorado
  - Denver, Colorado, Stany Zjednoczone, 80218-1088
    - Children's Hospital of Denver
  - Denver, Colorado, Stany Zjednoczone, 80218
    - Presbyterian - St. Luke's Medical Center
- Connecticut
  - Farmington, Connecticut, Stany Zjednoczone, 06360-7106
    - University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center
  - New Haven, Connecticut, Stany Zjednoczone, 06520-8028
    - Yale Comprehensive Cancer Center
- Delaware
  - Wilmington, Delaware, Stany Zjednoczone, 19899
    - Alfred I. DuPont Hospital for Children
- District of Columbia
  - Washington, District of Columbia, Stany Zjednoczone, 20007
    - Lombardi Cancer Center at Georgetown University Medical Center
  - Washington, District of Columbia, Stany Zjednoczone, 20010-2970
    - Children's National Medical Center
- Florida
  - Fort Lauderdale, Florida, Stany Zjednoczone, 33316
    - Broward General Medical Center
  - Fort Myers, Florida, Stany Zjednoczone, 33908
    - Children's Hospital of Southwest Florida
  - Gainesville, Florida, Stany Zjednoczone, 32610-0296
    - Shands Cancer Center at the University of Florida Health Science Center
  - Hollywood, Florida, Stany Zjednoczone, 33021
    - Joe DiMaggio Children's Hospital at Memorial
  - Jacksonville, Florida, Stany Zjednoczone, 32207
    - Nemours Children's Clinic
  - Miami, Florida, Stany Zjednoczone, 33155
    - Miami Children's Hospital
  - Miami, Florida, Stany Zjednoczone, 33136
    - Jackson Memorial Hospital
  - Miami, Florida, Stany Zjednoczone, 33176-2197
    - Baptist-South Miami Regional Cancer Program
  - Orlando, Florida, Stany Zjednoczone, 32804
    - Florida Hospital Cancer Institute
  - Orlando, Florida, Stany Zjednoczone, 32806
    - Nemours Children's Clinic-Orlando
  - Pensacola, Florida, Stany Zjednoczone, 32504
    - Sacred Heart Children's Hospital
  - St. Petersburg, Florida, Stany Zjednoczone, 33701
    - All Children's Hospital
  - Tampa, Florida, Stany Zjednoczone, 33677-4227
    - St. Joseph's Children's Hospital
  - West Palm Beach, Florida, Stany Zjednoczone, 33407
    - St. Mary's Hospital
- Georgia
  - Atlanta, Georgia, Stany Zjednoczone, 30342
    - AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
  - Augusta, Georgia, Stany Zjednoczone, 30912-4000
    - MBCCOP-Medical College of Georgia Cancer Center
  - Macon, Georgia, Stany Zjednoczone, 31201
    - Medical Center of Central Georgia
  - Savannah, Georgia, Stany Zjednoczone, 31405
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Hawaii
  - Honolulu, Hawaii, Stany Zjednoczone, 96859-5000
    - Tripler Army Medical Center
  - Honolulu, Hawaii, Stany Zjednoczone, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, Stany Zjednoczone, 96813
    - MBCCOP - Hawaii
- Idaho
  - Boise, Idaho, Stany Zjednoczone, 83712
    - Mountain States Tumor Institute - Boise
- Illinois
  - Chicago, Illinois, Stany Zjednoczone, 60612
    - Rush University Medical Center
  - Chicago, Illinois, Stany Zjednoczone, 60614
    - Children's Memorial Hospital - Chicago
  - Chicago, Illinois, Stany Zjednoczone, 60601
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, Stany Zjednoczone, 60612
    - University of Illinois Medical Center
  - Oak Lawn, Illinois, Stany Zjednoczone, 60453
    - Advocate Hope Children's Hospital
  - Park Ridge, Illinois, Stany Zjednoczone, 60068-1174
    - Lutheran General Cancer Care Center
  - Peoria, Illinois, Stany Zjednoczone, 61637
    - Saint Jude Midwest Affiliate
  - Springfield, Illinois, Stany Zjednoczone, 62794-9658
    - Southern Illinois University School of Medicine
- Indiana
  - Indianapolis, Indiana, Stany Zjednoczone, 46202-5225
    - Riley Children Cancer Center at Riley Hospital for Children
  - Indianapolis, Indiana, Stany Zjednoczone, 46260
    - St. Vincent Hospitals and Health Care Centers
- Iowa
  - Des Moines, Iowa, Stany Zjednoczone, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Stany Zjednoczone, 50308
    - Blank Children's Hospital
  - Iowa City, Iowa, Stany Zjednoczone, 52242-1009
    - Holden Comprehensive Cancer Center at University of Iowa
- Kansas
  - Wichita, Kansas, Stany Zjednoczone, 67214
    - Wesley Medical Center
- Kentucky
  - Lexington, Kentucky, Stany Zjednoczone, 40536-0284
    - Markey Cancer Center at University of Kentucky Chandler Medical Center
  - Louisville, Kentucky, Stany Zjednoczone, 40202-3830
    - Kosair Children's Hospital
- Louisiana
  - New Orleans, Louisiana, Stany Zjednoczone, 70121
    - Ochsner Clinic Foundation
  - New Orleans, Louisiana, Stany Zjednoczone, 70118
    - Children's Hospital of New Orleans
  - New Orleans, Louisiana, Stany Zjednoczone, 70112
    - MBCCOP - LSU Health Sciences Center
  - New Orleans, Louisiana, Stany Zjednoczone, 70112
    - Tulane Cancer Center at Tulane University Hospital and Clinic
- Maine
  - Bangor, Maine, Stany Zjednoczone, 04401
    - Eastern Maine Medical Center
  - Scarborough, Maine, Stany Zjednoczone, 04074-9308
    - Maine Children's Cancer Program
- Maryland
  - Baltimore, Maryland, Stany Zjednoczone, 21231-2410
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  - Baltimore, Maryland, Stany Zjednoczone, 21201-1595
    - Greenebaum Cancer Center at University of Maryland Medical Center
  - Baltimore, Maryland, Stany Zjednoczone, 21225
    - Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  - Silver Spring, Maryland, Stany Zjednoczone, 20910
    - Walter Reed Army Medical Center
- Massachusetts
  - Boston, Massachusetts, Stany Zjednoczone, 02115
    - Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  - Boston, Massachusetts, Stany Zjednoczone, 02111
    - Floating Hospital for Children
  - Springfield, Massachusetts, Stany Zjednoczone, 01107
    - Baystate Regional Cancer Program at Baystate Medical Center
  - Worcester, Massachusetts, Stany Zjednoczone, 01655
    - UMASS Memorial Cancer Center - University Campus
- Michigan
  - Ann Arbor, Michigan, Stany Zjednoczone, 48109-0914
    - University Of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, Stany Zjednoczone, 48201
    - Children's Hospital of Michigan
  - Detroit, Michigan, Stany Zjednoczone, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Detroit, Michigan, Stany Zjednoczone, 48202
    - Josephine Ford Cancer Center at Henry Ford Health System
  - Flint, Michigan, Stany Zjednoczone, 48503
    - Hurley Medical Center
  - Grand Rapids, Michigan, Stany Zjednoczone, 49503
    - Spectrum Health and DeVos Children's Hospital
  - Kalamazoo, Michigan, Stany Zjednoczone, 49007-5364
    - Bronson Methodist Hospital
  - Lansing, Michigan, Stany Zjednoczone, 48910
    - Breslin Cancer Center at Ingham Regional Medical Center
  - Royal Oak, Michigan, Stany Zjednoczone, 48073-6769
    - CCOP - Beaumont
  - Royal Oak, Michigan, Stany Zjednoczone, 48073-6769
    - William Beaumont Hospital - Royal Oak
- Minnesota
  - Duluth, Minnesota, Stany Zjednoczone, 55805
    - St. Mary's - Duluth Clinic Cancer Center
  - Minneapolis, Minnesota, Stany Zjednoczone, 55404
    - Children's Hospitals and Clinics - Minneapolis
  - Rochester, Minnesota, Stany Zjednoczone, 55905
    - Mayo Clinic Cancer Center
  - Saint Paul, Minnesota, Stany Zjednoczone, 55102
    - Children's Hospitals and Clinics - Minnesota
- Mississippi
  - Jackson, Mississippi, Stany Zjednoczone, 39216-4505
    - University of Mississippi Medical Center
- Missouri
  - Kansas City, Missouri, Stany Zjednoczone, 64108
    - Children's Mercy Hospital
  - Saint Louis, Missouri, Stany Zjednoczone, 63110
    - St. Louis Children's Hospital
  - Saint Louis, Missouri, Stany Zjednoczone, 63104
    - Cardinal Glennon Children's Hospital
- Nebraska
  - Omaha, Nebraska, Stany Zjednoczone, 68114
    - Children's Hospital of Omaha
  - Omaha, Nebraska, Stany Zjednoczone, 68198-2168
    - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Nevada
  - Las Vegas, Nevada, Stany Zjednoczone, 89109
    - Sunrise Hospital and Medical Center
- New Hampshire
  - Lebanon, New Hampshire, Stany Zjednoczone, 03756
    - Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- New Jersey
  - Hackensack, New Jersey, Stany Zjednoczone, 07601
    - Cancer Center at Hackensack University Medical Center
  - New Brunswick, New Jersey, Stany Zjednoczone, 08903
    - Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
  - Newark, New Jersey, Stany Zjednoczone, 07112-2094
    - Newark Beth Israel Medical Center
  - Paterson, New Jersey, Stany Zjednoczone, 07503
    - St. Joseph's Hospital and Medical Center
  - Summit, New Jersey, Stany Zjednoczone, 07901
    - Valerie Fund Children's Center at Atlantic Health
- New Mexico
  - Albuquerque, New Mexico, Stany Zjednoczone, 87131
    - University of New Mexico Cancer Research and Treatment Center
- New York
  - Albany, New York, Stany Zjednoczone, 12208
    - Cancer Center of Albany Medical Center
  - Bronx, New York, Stany Zjednoczone, 10461
    - Albert Einstein Clinical Cancer Center
  - Brooklyn, New York, Stany Zjednoczone, 11203
    - SUNY Downstate Medical Center
  - Brooklyn, New York, Stany Zjednoczone, 11212
    - Brookdale University Hospital and Medical Center
  - Brooklyn, New York, Stany Zjednoczone, 11201-5493
    - Brooklyn Hospital Center
  - Brooklyn, New York, Stany Zjednoczone, 11219
    - Comprehensive Cancer Center at Maimonides Medical Center
  - New Hyde Park, New York, Stany Zjednoczone, 11042
    - Schneider Children's Hospital
  - New York, New York, Stany Zjednoczone, 10021
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, Stany Zjednoczone, 10029
    - Mount Sinai School of Medicine
  - New York, New York, Stany Zjednoczone, 10021
    - New York Weill Cornell Cancer Center at Cornell University
  - New York, New York, Stany Zjednoczone, 10032
    - Herbert Irving Comprehensive Cancer Center at Columbia University
  - Rochester, New York, Stany Zjednoczone, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Stony Brook, New York, Stany Zjednoczone, 11794
    - Long Island Cancer Center at Stony Brook University Hospital
  - Syracuse, New York, Stany Zjednoczone, 13210
    - SUNY Upstate Medical University Hospital
  - Valhalla, New York, Stany Zjednoczone, 10595
    - New York Medical College
- North Carolina
  - Asheville, North Carolina, Stany Zjednoczone, 28801
    - Mission Hospitals
  - Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7295
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Charlotte, North Carolina, Stany Zjednoczone, 28232-2861
    - Blumenthal Cancer Center at Carolinas Medical Center
  - Charlotte, North Carolina, Stany Zjednoczone, 28233
    - Presbyterian Healthcare
  - Durham, North Carolina, Stany Zjednoczone, 27710
    - Duke Comprehensive Cancer Center
  - Greenville, North Carolina, Stany Zjednoczone, 27858-4354
    - Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
  - Winston-Salem, North Carolina, Stany Zjednoczone, 27157-1081
    - Comprehensive Cancer Center at Wake Forest University
- North Dakota
  - Fargo, North Dakota, Stany Zjednoczone, 58103-4940
    - Dakota Cancer Institute at Innovis Health - Dakota Clinic
- Ohio
  - Akron, Ohio, Stany Zjednoczone, 44308-1062
    - Children's Hospital Medical Center of Akron
  - Cincinnati, Ohio, Stany Zjednoczone, 45229-3039
    - Cincinnati Children's Hospital Medical Center
  - Cleveland, Ohio, Stany Zjednoczone, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, Stany Zjednoczone, 44106-5065
    - Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
  - Columbus, Ohio, Stany Zjednoczone, 43205-2696
    - Columbus Children's Hospital
  - Dayton, Ohio, Stany Zjednoczone, 45404
    - Children's Medical Center - Dayton
  - Toledo, Ohio, Stany Zjednoczone, 43601
    - Toledo Children's Hospital
  - Toledo, Ohio, Stany Zjednoczone, 43608
    - St. Vincent Mercy Medical Center
  - Youngstown, Ohio, Stany Zjednoczone, 44501
    - Forum Health-Tod Childrens Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
    - Children's Hospital at Oklahoma University Medical Center
  - Tulsa, Oklahoma, Stany Zjednoczone, 74136
    - Natalie Warren Bryant Cancer Center
  - Tulsa, Oklahoma, Stany Zjednoczone, 74136
    - CCOP - Oklahoma
- Oregon
  - Portland, Oregon, Stany Zjednoczone, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, Stany Zjednoczone, 97227
    - Legacy Emanuel Hospital and Health Center & Children's Hospital
  - Portland, Oregon, Stany Zjednoczone, 97239-3098
    - Doernbecher Children's Hospital at Oregon Health & Science University
- Pennsylvania
  - Danville, Pennsylvania, Stany Zjednoczone, 17822-1320
    - Geisinger Medical Center
  - Hershey, Pennsylvania, Stany Zjednoczone, 17033
    - Penn State Cancer Institute at Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
    - Children's Hospital of Philadelphia
  - Philadelphia, Pennsylvania, Stany Zjednoczone, 19134-1095
    - St. Christopher's Hospital for Children
  - Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213-2583
    - Children's Hospital of Pittsburgh
- Rhode Island
  - Providence, Rhode Island, Stany Zjednoczone, 02903
    - Rhode Island Hospital
- South Carolina
  - Charleston, South Carolina, Stany Zjednoczone, 29425-0721
    - Hollings Cancer Center at Medical University of South Carolina
  - Columbia, South Carolina, Stany Zjednoczone, 29203
    - Palmetto Health South Carolina Cancer Center
  - Greenville, South Carolina, Stany Zjednoczone, 29605
    - Children's Hospital of Greenville Hospital System
- South Dakota
  - Sioux Falls, South Dakota, Stany Zjednoczone, 57105-1080
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5039
    - Sioux Valley Hospital at University of South Dakota Medical Center
- Tennessee
  - Johnson City, Tennessee, Stany Zjednoczone, 37614-0622
    - East Tennessee State University Cancer Center at Johnson City Medical Center
  - Knoxville, Tennessee, Stany Zjednoczone, 37901
    - East Tennessee Children's Hospital
  - Memphis, Tennessee, Stany Zjednoczone, 38105-2794
    - St. Jude Children's Research Hospital
  - Nashville, Tennessee, Stany Zjednoczone, 37232-6310
    - Vanderbilt Children's Hospital
- Texas
  - Amarillo, Texas, Stany Zjednoczone, 79106
    - Texas Tech University Health Sciences Center School of Medicine
  - Austin, Texas, Stany Zjednoczone, 78701
    - Children's Hospital of Austin
  - Dallas, Texas, Stany Zjednoczone, 75230
    - Medical City Dallas Hospital
  - Dallas, Texas, Stany Zjednoczone, 75390-9063
    - Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  - Fort Worth, Texas, Stany Zjednoczone, 76104
    - Cook Children's Medical Center - Fort Worth
  - Galveston, Texas, Stany Zjednoczone, 77555-0361
    - University of Texas Medical Branch
  - Houston, Texas, Stany Zjednoczone, 77030
    - Baylor College of Medicine
  - Houston, Texas, Stany Zjednoczone, 77030-4009
    - University of Texas - MD Anderson Cancer Center
  - Lackland Air Force Base, Texas, Stany Zjednoczone, 78236
    - San Antonio Military Pediatric Cancer and Blood Disorders Center
  - Lubbock, Texas, Stany Zjednoczone, 79410
    - Covenant Children's Hospital
  - San Antonio, Texas, Stany Zjednoczone, 78207
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, Stany Zjednoczone, 78229-3900
    - MBCCOP - South Texas Pediatrics
  - San Antonio, Texas, Stany Zjednoczone, 78229-3902
    - Methodist Cancer Center at Methodist Specialty and Transplant Hospital
  - Temple, Texas, Stany Zjednoczone, 76508
    - CCOP - Scott and White Hospital
  - Temple, Texas, Stany Zjednoczone, 76508
    - Center for Cancer Prevention and Care at Scott and White Clinic
- Utah
  - Salt Lake City, Utah, Stany Zjednoczone, 84112
    - Huntsman Cancer Institute
- Vermont
  - Burlington, Vermont, Stany Zjednoczone, 05401-3498
    - Vermont Cancer Center at University of Vermont
- Virginia
  - Charlottesville, Virginia, Stany Zjednoczone, 22908
    - Cancer Center at the University of Virginia
  - Falls Church, Virginia, Stany Zjednoczone, 22042-3300
    - INOVA Fairfax Hospital
  - Norfolk, Virginia, Stany Zjednoczone, 23507
    - Children's Hospital of The King's Daughters
  - Portsmouth, Virginia, Stany Zjednoczone, 23708-5100
    - Naval Medical Center, Portsmouth
  - Richmond, Virginia, Stany Zjednoczone, 23298-0121
    - Massey Cancer Center at Virginia Commonwealth University
  - Roanoke, Virginia, Stany Zjednoczone, 24029
    - Carilion Medical Center for Children
- Washington
  - Seattle, Washington, Stany Zjednoczone, 98105
    - Children's Hospital and Regional Medical Center - Seattle
  - Seattle, Washington, Stany Zjednoczone, 98109-1024
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, Stany Zjednoczone, 98112
    - Group Health Central Hospital
  - Spokane, Washington, Stany Zjednoczone, 99210-0248
    - Deaconess Medical Center
  - Tacoma, Washington, Stany Zjednoczone, 98431-5000
    - Madigan Army Medical Center
  - Tacoma, Washington, Stany Zjednoczone, 98415-0299
    - Mary Bridge Children's Hospital and Health Center
- West Virginia
  - Charleston, West Virginia, Stany Zjednoczone, 25302
    - West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  - Huntington, West Virginia, Stany Zjednoczone, 25701
    - Cabell Huntington Hospital
  - Morgantown, West Virginia, Stany Zjednoczone, 26506-9300
    - West Virginia University Hospitals
- Wisconsin
  - Green Bay, Wisconsin, Stany Zjednoczone, 54301
    - CCOP - St. Vincent Hospital Cancer Center, Green Bay
  - Green Bay, Wisconsin, Stany Zjednoczone, 54301
    - Bellin Memorial Hospital
  - Green Bay, Wisconsin, Stany Zjednoczone, 54307-9070
    - St. Vincent Hospital
  - La Crosse, Wisconsin, Stany Zjednoczone, 54601
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  - Madison, Wisconsin, Stany Zjednoczone, 53792-6164
    - University of Wisconsin Comprehensive Cancer Center
  - Marshfield, Wisconsin, Stany Zjednoczone, 54449-5772
    - Marshfield Clinic
  - Marshfield, Wisconsin, Stany Zjednoczone, 54449
    - CCOP - Marshfield Clinic Research Foundation
  - Milwaukee, Wisconsin, Stany Zjednoczone, 53226
    - Midwest Children's Cancer Center
Szwajcaria
- - Bern, Szwajcaria, CH 3010
    - Swiss Pediatric Oncology Group Bern
  - Geneva, Szwajcaria, CH 1211
    - Swiss Pediatric Oncology Group Geneva
  - Lausanne, Szwajcaria, CH 1011
    - Swiss Pediatric Oncology Group Lausanne

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Nie starszy niż 21 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Przydział: Nie dotyczy
Model interwencyjny: Zadanie dla jednej grupy
Maskowanie: Brak (otwarta etykieta)

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm	Interwencja / Leczenie
Eksperymentalny: Treatment 1 - Asymptomatic - no immediate chemotherapy	Promieniowanie: radioterapia Procedura: operacja konwencjonalna
Eksperymentalny: Symptomatic - immediate chemotherapy	Lek: karboplatyna Lek: cyklofosfamid Promieniowanie: radioterapia Lek: etopozyd Procedura: leczenie uzupełniające Lek: chlorowodorek doksorubicyny Procedura: operacja konwencjonalna Biologiczny: filgrastym Biologiczny: sargramostym

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka
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.

Miara wyniku

Opis środka

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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Children's Oncology Group

Współpracownicy

National Cancer Institute (NCI)

Śledczy

Krzesło do nauki: Douglas R. Strother, MD, Alberta Children's Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

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.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 marca 1998

Zakończenie podstawowe (Rzeczywisty)

1 marca 2006

Ukończenie studiów (Rzeczywisty)

1 marca 2006

Daty rejestracji na studia

Pierwszy przesłany

1 listopada 1999

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 stycznia 2003

Pierwszy wysłany (Oszacować)

27 stycznia 2003

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 marca 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 marca 2017

Ostatnia weryfikacja

1 marca 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

P9641
COG-P9641 (Inny identyfikator: Children's Oncology Group)
POG-P9641 (Inny identyfikator: Pediatric Oncology Group)
CCG-P9641 (Inny identyfikator: Children's Cancer Group)
CDR0000065874 (Inny identyfikator: Clinical Trials.gov)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Surgery in Treating Children With Neuroblastoma

Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study

Przegląd badań

Status

Warunki

Interwencja / Leczenie

Szczegółowy opis

Typ studiów

Zapisy (Rzeczywisty)

Faza

Kontakty i lokalizacje

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Płeć kwalifikująca się do nauki

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Opis środka

Współpracownicy i badacze

Sponsor

Współpracownicy

Śledczy

Publikacje i pomocne linki

Publikacje ogólne

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów

Zakończenie podstawowe (Rzeczywisty)

Ukończenie studiów (Rzeczywisty)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Oszacować)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania