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Surgery in Treating Children With Neuroblastoma

9. mars 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Nevroblastom

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

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

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

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

Regimen I

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

Regimen II

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

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

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

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

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

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

Studietype

Intervensjonell

Registrering (Faktiske)

968

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 21 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Histologically proven low-risk neuroblastoma (excluding ganglioneuroma)
- International Neuroblastoma Staging System (INSS) stage 1 in all patients
- INSS stage 2A or 2B in patients less than 365 days of age
- INSS stage 2A or 2B tumor with nonamplified MYCN with any Shimada histology in patients ages 1 to 20 years
- INSS stage 2A or 2B tumor with amplified MYCN with Shimada favorable histology in patients ages 1 to 20 years
- INSS stage 4S tumors with nonamplified MYCN, Shimada favorable histology, and a DNA index not equal to 1 in patients less than 365 days of age
Immediate chemotherapy allowed prior to biopsy for patients with intradural extension and/or emergent paresis if biopsy performed within 96 hours
- Must have no abnormal organ function unless due to neuroblastoma
Concurrent registration on companion biology study (protocol COG-ANBL00B1) or its successor

PATIENT CHARACTERISTICS:

Age:

Under 21

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin less than 1.5 times normal
SGOT or SGPT less than 2.5 times normal

Renal:

Creatinine less than 1.5 times normal

Cardiovascular:

Shortening fraction greater than 27% by echocardiogram OR
Ejection fraction greater than 47% by radionuclide angiogram

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior immunotherapy

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

No prior hormonal therapy

Radiotherapy:

No prior radiotherapy

Surgery:

Prior surgery allowed

Other:

No other prior therapy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: N/A
Intervensjonsmodell: Enkeltgruppeoppdrag
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: Treatment 1 - Asymptomatic - no immediate chemotherapy	Stråling: strålebehandling Fremgangsmåte: konvensjonell kirurgi
Eksperimentell: Symptomatic - immediate chemotherapy	Legemiddel: karboplatin Legemiddel: cyklofosfamid Stråling: strålebehandling Legemiddel: etoposid Fremgangsmåte: adjuvant terapi Legemiddel: doksorubicinhydroklorid Fremgangsmåte: konvensjonell kirurgi Biologisk: filgrastim Biologisk: sargramostim

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse
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.

Resultatmål

Tiltaksbeskrivelse

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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Children's Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Studiestol: Douglas R. Strother, MD, Alberta Children's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 1998

Primær fullføring (Faktiske)

1. mars 2006

Studiet fullført (Faktiske)

1. mars 2006

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Nevroblastom

Children's Oncology Group
National Cancer Institute (NCI)

Aktiv, ikke rekrutterende

Busulfan, melfalan og stamcelletransplantasjon etter kjemoterapi ved behandling av pasienter med nylig diagnostisert høyrisikoneuroblastom

Stage 4S Neuroblastom | Ganglioneuroblastom | Stage 2A Nevroblastom | Stage 2B Nevroblastom | Stadium 3 Neuroblastom | Stadium 4 Nevroblastom | Fase 1 Neuroblastom | Stadium 2 Neuroblastom

Forente stater, Canada, Australia, New Zealand
Children's Oncology Group
National Cancer Institute (NCI)

Aktiv, ikke rekrutterende

Seneffekter etter behandling hos pasienter med tidligere diagnostisert høyrisikoneuroblastom

Tilbakevendende nevroblastom | Stage 4S Neuroblastom | Stage 2A Nevroblastom | Stage 2B Nevroblastom | Stadium 3 Neuroblastom | Stadium 4 Nevroblastom

Forente stater, Canada, Australia, New Zealand
St. Jude Children's Research Hospital
Mayo Clinic

Avsluttet

En fase II-studie av intensitetsmodulert strålebehandling (IMRT) ved høyrisiko abdominalneuroblastom

Abdominal neuroblastom

Forente stater
Children's Oncology Group
National Cancer Institute (NCI)

Fullført

Studie av prøver fra unge pasienter med nevroblastom

Lokalisert resektabelt nevroblastom | Lokalisert uoperabelt nevroblastom | Regionalt nevroblastom | Stage 4S Neuroblastom

Forente stater
Children's Oncology Group
National Cancer Institute (NCI)

Rekruttering

Biomarkører i svulstvevsprøver fra pasienter med nylig diagnostisert nevroblastom eller ganglioneuroblastom

Lokalisert resektabelt nevroblastom | Lokalisert uoperabelt nevroblastom | Regionalt nevroblastom | Stage 4S Neuroblastom | Ganglioneuroblastom | Stadium 4 Nevroblastom

Forente stater, Puerto Rico, Canada, Australia, New Zealand, Nederland, Saudi-Arabia, Sveits
Children's Oncology Group
National Cancer Institute (NCI)

Aktiv, ikke rekrutterende

Induksjonsterapi inkludert 131 I-MIBG og kjemoterapi ved behandling av pasienter med nylig diagnostisert høyrisikoneuroblastom som gjennomgår stamcelletransplantasjon, strålebehandling og vedlikeholdsterapi med isotretinoin

Lokalisert resektabelt nevroblastom | Lokalisert uoperabelt nevroblastom | Regionalt nevroblastom | Stage 4S Neuroblastom | Ganglioneuroblastom | Stadium 4 Nevroblastom

Forente stater
Children's Oncology Group
National Cancer Institute (NCI)

Fullført

Studie av DNA i blodprøver fra pasienter med nevroblastom

Tilbakevendende nevroblastom | Disseminert nevroblastom | Lokalisert resektabelt nevroblastom | Lokalisert uoperabelt nevroblastom | Regionalt nevroblastom | Stage 4S Neuroblastom

Forente stater
Children's Oncology Group
National Cancer Institute (NCI)

Fullført

Prognostic Biomarkers in Tumor Tissue Samples From Young Patients With Neuroblastoma

Tilbakevendende nevroblastom | Disseminert nevroblastom | Lokalisert resektabelt nevroblastom | Lokalisert uoperabelt nevroblastom | Stage 4S Neuroblastom

Forente stater
National Cancer Institute (NCI)

Aktiv, ikke rekrutterende

Isotretinoin med eller uten Dinutuximab, Aldesleukin og Sargramostim etter stamcelletransplantasjon ved behandling av pasienter med nevroblastom

Tilbakevendende nevroblastom | Lokalisert resektabelt nevroblastom | Lokalisert uoperabelt nevroblastom | Regionalt nevroblastom | Stage 4S Neuroblastom | Stadium 4 Nevroblastom

Forente stater, Canada, Australia, New Zealand, Puerto Rico
Children's Oncology Group
National Cancer Institute (NCI)

Fullført

Sammenligning av to forskjellige myeloablasjonsterapier for behandling av unge pasienter som gjennomgår en stamcelletransplantasjon for høyrisikoneuroblastom

Tilbakevendende nevroblastom | Lokalisert resektabelt nevroblastom | Lokalisert uoperabelt nevroblastom | Regionalt nevroblastom | Stage 4S Neuroblastom | Stadium 4 Nevroblastom

Forente stater, Canada, Australia, New Zealand, Puerto Rico, Sveits

Kliniske studier på karboplatin

Samyang Biopharmaceuticals Corporation

Fullført

Bestem MTD, evaluer effektiviteten og sikkerheten til Genexol®-PM Plus Carboplatin med avansert eggstokkreft

Eggstokkreft
Akeso

Rekruttering

AK112 i kombinasjon med kjemoterapi ved avansert plateepitel, ikke-småcellet lungekreft

Avansert plateepitel, ikke-småcellet lungekreft

Kina
Shanghai Shengdi Pharmaceutical Co., Ltd

Har ikke rekruttert ennå

En fase II/III-studie av Adebrelimab i kombinasjon med SHR-8068 og kjemoterapi hos avanserte eller metastatiske NSCLC-pasienter

Ikke-plateepitel Ikke-småcellet lungekreft

Kina
Samyang Biopharmaceuticals Corporation

Fullført

En studie for å evaluere effektiviteten og sikkerheten til kombinasjonsterapien av Genexol®-PM Plus Carboplatin® sammenlignet med Genexol® Plus Carboplatin® som førstelinjebehandling hos pasienter med eggstokkreft (GPMOC202)

Eggstokkreft

Korea, Republikken
Gynecologic Oncology Trial & Investigation Consortium
Japanese Gynecologic Oncology Group

Fullført

Intraperitoneal terapi for eggstokkreft med karboplatinforsøk (iPocc)

Egglederkreft | Epitelial eggstokkreft | Primært peritonealt karsinom

Japan, Forente stater, Hong Kong, Korea, Republikken, New Zealand, Singapore
National Cancer Institute (NCI)

Fullført

AZD2281 Plus Carboplatin for å behandle bryst- og eggstokkreft

Brystkreft | Eggstokkreft

Forente stater
Rennes University Hospital

Fullført

Studie av prediktive faktorer for kjemoresistens i eggstokkreft (FaCliBioCCo)

Eggstokkreft

Frankrike
Myrexis Inc.

Ukjent

Fase 1-studie av MPC-6827 og Carboplatin ved residiverende/residiverende glioblastoma multiforme

Glioblastoma Multiforme

Forente stater
The First Affiliated Hospital of Guangzhou Medical...

Ukjent

Pegylert liposomal doksorubicin og karboplatin som førstelinjebehandling for pasienter med avansert ikke-småcellet lungekreft

Ikke-småcellet lungekreft

Kina
Sharon Stein
Merck Sharp & Dohme LLC

Avsluttet

Alvimopan som redning i Post op Ileus

Kolorektal kirurgi | Ileus

Forente stater

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

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Faktiske)

Fase

Kontakter og plasseringer

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Samarbeidspartnere og etterforskere

Sponsor

Samarbeidspartnere

Etterforskere

Publikasjoner og nyttige lenker

Generelle publikasjoner

Studierekorddatoer

Studer hoveddatoer

Studiestart

Primær fullføring (Faktiske)

Studiet fullført (Faktiske)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Anslag)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Kliniske studier på Nevroblastom

Kliniske studier på karboplatin

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Türkiye

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder