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Surgery in Treating Children With Neuroblastoma

9 maart 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Neuroblastoom

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

968

Fase

Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 21 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: NVT
Interventioneel model: Opdracht voor een enkele groep
Masker: Geen (open label)

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: Treatment 1 - Asymptomatic - no immediate chemotherapy	Straling: bestralingstherapie Procedure: conventionele chirurgie
Experimenteel: Symptomatic - immediate chemotherapy	Geneesmiddel: carboplatine Geneesmiddel: cyclofosfamide Straling: bestralingstherapie Geneesmiddel: etoposide Procedure: adjuvante therapie Geneesmiddel: doxorubicine hydrochloride Procedure: conventionele chirurgie Biologisch: filgrastim Biologisch: sargramostim

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving
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.

Uitkomstmaat

Maatregel Beschrijving

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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Children's Oncology Group

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 1998

Primaire voltooiing (Werkelijk)

1 maart 2006

Studie voltooiing (Werkelijk)

1 maart 2006

Studieregistratiedata

Eerst ingediend

1 november 1999

Eerst ingediend dat voldeed aan de QC-criteria

26 januari 2003

Eerst geplaatst (Schatting)

27 januari 2003

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 maart 2017

Laatste update ingediend die voldeed aan QC-criteria

9 maart 2017

Laatst geverifieerd

1 maart 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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

Studie Overzicht

Toestand

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Studietype

Inschrijving (Werkelijk)

Fase

Contacten en locaties

Studie Locaties

Deelname Criteria

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Beschrijving

Studie plan

Hoe is de studie opgezet?

Ontwerpdetails

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm

Interventie / Behandeling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat

Maatregel Beschrijving

Medewerkers en onderzoekers

Sponsor

Medewerkers

Onderzoekers

Publicaties en nuttige links

Algemene publicaties

Studie record data

Bestudeer belangrijke data

Studie start

Primaire voltooiing (Werkelijk)

Studie voltooiing (Werkelijk)

Studieregistratiedata

Eerst ingediend

Eerst ingediend dat voldeed aan de QC-criteria

Eerst geplaatst (Schatting)

Updates van studierecords

Laatste update geplaatst (Werkelijk)

Laatste update ingediend die voldeed aan QC-criteria

Laatst geverifieerd

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers