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Surgery in Treating Children With Neuroblastoma

9 marzo 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Neuroblastoma

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

To determine if asymptomatic patients with low-risk neuroblastoma treated with surgery alone will have a 3-year survival rate of 95%.
Estimate the response and 3-year event-free survival rates of symptomatic patients treated with chemotherapy.
Estimate the event-free survival and overall survival rates in patients who relapse or progress after initial treatment with surgery alone.
Determine the acute and chronic toxic effects associated with treating low-risk neuroblastoma with surgery alone or surgery and chemotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage, MYCN status, age, and histology.

Patients undergo primary tumor resection and biopsy of regional nodes. Patients with at least 50% of the tumor resected are followed monthly for 3 months, every 3 months for 9 months, every 6 months for one year, and then annually thereafter.

Regimen I

Patients with clinically symptomatic (e.g., respiratory distress, spinal cord compromise with or without neurologic deficit, inferior vena cava compression with renal or bowel ischemia, intractable vomiting due to gastrointestinal obstruction, genitourinary obstruction, or coagulopathy) low-risk neuroblastoma or who have less than 50% of the primary tumor resected receive 4 different courses of chemotherapy.
Course 1: Patients receive carboplatin IV over 1 hour followed by etoposide IV over 2 hours on day 0 and etoposide only on days 1 and 2.
Course 2: Patients receive carboplatin IV over 1 hour, cyclophosphamide IV over 1 hour, and doxorubicin IV over 15-60 minutes on day 1.
Course 3: Patients receive cyclophosphamide IV over 1 hour followed by etoposide IV over 2 hours on day 0 and etoposide only on days 1 and 2.
Course 4: Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours followed by doxorubicin IV over 15-60 minutes on day 0 and etoposide only on days 1 and 2.

Regimen II

Patients who progress to or recur with unfavorable biology intermediate-risk disease receive an additional 4 courses of chemotherapy.
Course 5: Patients receive treatment as in course 3 above.
Course 6: Patients receive treatment as in course 2 above.
Course 7: Patients receive treatment as in course 1 above.
Course 8: Patients receive cyclophosphamide IV over 1 hour followed by doxorubicin IV over 15-60 minutes on day 1.

All infants under 60 days of age receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 to 36 hours after chemotherapy and continuing until blood counts recover.

Courses in both regimens repeat every 3 weeks in the absence of unacceptable toxicity.

Patients at risk for symptomatic spinal cord compression may also receive chemotherapy. Patients experiencing progressive or recurrent disease after observation undergo repeat surgery and/or chemotherapy as above. Patients with clinically symptomatic disease may also undergo radiotherapy if response to chemotherapy is not rapid.

Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within 4 years.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

968

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 21 anni (Bambino, Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: N / A
Modello interventistico: Assegnazione di gruppo singolo
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: Treatment 1 - Asymptomatic - no immediate chemotherapy	Radiazione: radioterapia Procedura: chirurgia convenzionale
Sperimentale: Symptomatic - immediate chemotherapy	Droga: carboplatino Droga: ciclofosfamide Radiazione: radioterapia Droga: etoposide Procedura: terapia adiuvante Droga: doxorubicina cloridrato Procedura: chirurgia convenzionale Biologico: filgrastim Biologico: sargramostim

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione
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.

Misura del risultato

Misura Descrizione

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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Children's Oncology Group

Collaboratori

National Cancer Institute (NCI)

Investigatori

Cattedra di studio: Douglas R. Strother, MD, Alberta Children's Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 1998

Completamento primario (Effettivo)

1 marzo 2006

Completamento dello studio (Effettivo)

1 marzo 2006

Date di iscrizione allo studio

Primo inviato

1 novembre 1999

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 marzo 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tipo di studio

Iscrizione (Effettivo)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Collaboratori e investigatori

Sponsor

Collaboratori

Investigatori

Pubblicazioni e link utili

Pubblicazioni generali

Studiare le date dei record

Studia le date principali

Inizio studio

Completamento primario (Effettivo)

Completamento dello studio (Effettivo)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Stima)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio