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Combination Chemotherapy in Treating Children With Neuroblastoma

2014년 7월 31일 업데이트: Children's Oncology Group

Treatment for Infants and Children With Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Combination chemotherapy plus surgery may be an effective treatment for neuroblastoma.

PURPOSE: This phase III trial is studying how well combination chemotherapy followed by surgery works in treating young patients with neuroblastoma.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

OBJECTIVES:

  • Determine whether the use of selected prognostic variables to assign treatment increases the event-free survival and overall survival in children with intermediate-risk neuroblastoma.
  • Determine the acute and long-term morbidity and toxicity of surgery and combination chemotherapy in this patient population.
  • Assess the relationship between extent of tumor resection and event-free and overall survival in patients treated with this regimen.

OUTLINE: Patients receive carboplatin IV over 1 hour on days 0, 21, and 63; cyclophosphamide IV over 1 hour on days 21 and 42; doxorubicin IV over 15-60 minutes on days 21 and 63; and etoposide IV over 2 hours on days 0-2, 42-44, and 63-65. Patients under 60 days of age also receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after the last chemotherapy administration and continuing until blood counts recover. Patients with favorable biology who do not achieve complete remission then undergo surgery to remove or debulk residual disease on day 84 or when blood counts recover. Patients with favorable biology who achieve partial response and surgery to the primary site is not deemed in the best interest of the patient may receive additional chemotherapy (as below) and delay surgery to the primary site after completion of chemotherapy.

Patients with unfavorable biology receive additional chemotherapy comprising cyclophosphamide IV over 1 hour on days 84, 105, and 147; etoposide IV over 2 hours on days 84-86 and 126-128; carboplatin IV over 1 hour on days 105 and 126; and doxorubicin IV over 15-60 minutes on days 105 and 147. Patients then undergo debulking surgery on day 168 or when blood counts recover.

Some patients may then undergo radiotherapy after surgery.

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

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

연구 유형

중재적

등록 (실제)

573

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 네덜란드
      • Groningen, 네덜란드, 9700 RB
        • University Medical Center Groningen
  • 뉴질랜드
      • Auckland, 뉴질랜드
        • Starship Children's Health
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35233
        • Comprehensive Cancer Center at University of Alabama at Birmingham
      • Mobile, Alabama, 미국, 36604
        • University of South Alabama Cancer Research Institute
    • Arizona
      • Phoenix, Arizona, 미국, 85016
        • Phoenix Children's Hospital
      • Tucson, Arizona, 미국, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, 미국, 90242
        • Southern California Permanente Medical Group
      • Duarte, California, 미국, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • La Jolla, California, 미국, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • Loma Linda, California, 미국, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, 미국, 90801-1428
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, 미국, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, 미국, 90027-0700
        • Children's Hospital Los Angeles
      • Los Angeles, California, 미국, 90048
        • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
      • Madera, California, 미국, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, 미국, 94609-1809
        • Children's Hospital and Research Center - Oakland
      • Orange, California, 미국, 92868
        • Children's Hospital of Orange County
      • Orange, California, 미국, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
      • Palo Alto, California, 미국, 94304
        • Lucile Packard Children's Hospital at Stanford University Medical Center
      • Sacramento, California, 미국, 95816
        • Sutter Cancer center
      • Sacramento, California, 미국, 95817
        • University of California Davis Cancer Center
      • Sacramento, California, 미국, 95825
        • Kaiser Permanente Medical Center - Sacramento
      • San Diego, California, 미국, 92123-4282
        • Children's Hospital and Health Center - San Diego
      • San Diego, California, 미국, 92120
        • Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
      • San Francisco, California, 미국, 94143
        • UCSF Comprehensive Cancer Center
      • Santa Barbara, California, 미국, 93102
        • Santa Barbara Cottage Children's Hospital
      • Santa Clara, California, 미국, 95051
        • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
      • Travis Air Force Base, California, 미국, 94535
        • General Robert Huyser Cancer Center at David Grant Medical Center
    • Colorado
      • Denver, Colorado, 미국, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, 미국, 80218
        • Children's Hospital Cancer Center
    • Connecticut
      • Farmington, Connecticut, 미국, 06360-7106
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
      • New Haven, Connecticut, 미국, 06520-8064
        • Yale Comprehensive Cancer Center at Yale University School of Medicine
    • Delaware
      • Wilmington, Delaware, 미국, 19899
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, 미국, 20007
        • Lombardi Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, 미국, 20010-2970
        • Children's National Medical Center
    • Florida
      • Fort Lauderdale, Florida, 미국, 33316
        • Broward General Medical Center Cancer Center
      • Fort Myers, Florida, 미국, 33908
        • Children's Hospital of Southwest Florida
      • Gainesville, Florida, 미국, 32610-0296
        • University of Florida Shands Cancer Center
      • Hollywood, Florida, 미국, 33021
        • Joe DiMaggio Children's Hospital at Memorial
      • Jacksonville, Florida, 미국, 32207
        • Nemours Children's Clinic
      • Miami, Florida, 미국, 33155
        • Miami Children's Hospital
      • Miami, Florida, 미국, 33136
        • Jackson Memorial Hospital
      • Miami, Florida, 미국, 33176-2197
        • Baptist-South Miami Regional Cancer Program
      • Orlando, Florida, 미국, 32804
        • Florida Hospital Cancer Institute
      • Orlando, Florida, 미국, 32806
        • Nemours Children's Clinic - Orlando
      • Pensacola, Florida, 미국, 32504
        • Sacred Heart Children's Hospital
      • St. Petersburg, Florida, 미국, 33701
        • All Children's Hospital
      • Tampa, Florida, 미국, 33677-4227
        • St. Joseph's Children's Hospital of Tampa
      • West Palm Beach, Florida, 미국, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, 미국, 30342
        • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
      • Augusta, Georgia, 미국, 30912-4000
        • MBCCOP-Medical College of Georgia Cancer Center
      • Macon, Georgia, 미국, 31201
        • Medical Center of Central Georgia
      • Savannah, Georgia, 미국, 31405
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, 미국, 96859-5000
        • Tripler Army Medical Center
      • Honolulu, Hawaii, 미국, 96813
        • Cancer Research Center of Hawaii
      • Honolulu, Hawaii, 미국, 96813
        • MBCCOP - Hawaii
    • Idaho
      • Boise, Idaho, 미국, 83712
        • St. Luke's Mountain States Tumor Institute - Boise
    • Illinois
      • Chicago, Illinois, 미국, 60612
        • Rush University Medical Center
      • Chicago, Illinois, 미국, 60614
        • Children's Memorial Hospital - Chicago
      • Chicago, Illinois, 미국, 60601
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, 미국, 60612
        • University of Illinois at Chicago Cancer Center
      • Oak Lawn, Illinois, 미국, 60453
        • Advocate Hope Children's Hospital
      • Park Ridge, Illinois, 미국, 60068-1174
        • Lutheran General Cancer Care Center
      • Peoria, Illinois, 미국, 61637
        • Saint Jude Midwest Affiliate
      • Springfield, Illinois, 미국, 62794-9658
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, 미국, 46260
        • St. Vincent Indianapolis Hospital
      • Indianapolis, Indiana, 미국, 46202-5225
        • Riley's Children Cancer Center at Riley Hospital for Children
    • Iowa
      • Des Moines, Iowa, 미국, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, 미국, 50308
        • Blank Children's Hospital
      • Iowa City, Iowa, 미국, 52242-1009
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Wichita, Kansas, 미국, 67214
        • Wesley Medical Center
    • Kentucky
      • Lexington, Kentucky, 미국, 40536-0284
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, 미국, 40202-3830
        • Kosair Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, 미국, 70118
        • Children's Hospital of New Orleans
      • New Orleans, Louisiana, 미국, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, 미국, 70121
        • Ochsner Cancer Institute at Ochsner Clinic Foundation
      • New Orleans, Louisiana, 미국, 70112
        • Tulane Cancer Center at Tulane University Hospital and Clinic
    • Maine
      • Bangor, Maine, 미국, 04401
        • Pediatric Specialty Clinic at Eastern Maine Medical Center
      • Scarborough, Maine, 미국, 04074-9308
        • Maine Children's Cancer Program
    • Maryland
      • Baltimore, Maryland, 미국, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
      • Baltimore, Maryland, 미국, 21201-1595
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Baltimore, Maryland, 미국, 21231-7223
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Silver Spring, Maryland, 미국, 20910
        • Walter Reed Army Medical Center
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, 미국, 02111
        • Floating Hospital for Children
      • Springfield, Massachusetts, 미국, 01107
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
      • Worcester, Massachusetts, 미국, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109-0914
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, 미국, 48201
        • Children's Hospital of Michigan
      • Detroit, Michigan, 미국, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Flint, Michigan, 미국, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, 미국, 49503
        • DeVos Children's Hospital
      • Kalamazoo, Michigan, 미국, 49007-5364
        • Bronson Methodist Hospital
      • Lansing, Michigan, 미국, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
      • Royal Oak, Michigan, 미국, 48073-6769
        • CCOP - Beaumont
      • Royal Oak, Michigan, 미국, 48073-6769
        • William Beaumont Hospital - Royal Oak Campus
    • Minnesota
      • Duluth, Minnesota, 미국, 55805
        • St. Mary's - Duluth Clinic Cancer Center
      • Minneapolis, Minnesota, 미국, 55404
        • Children's Hospitals and Clinics - Minneapolis/St. Paul
      • Rochester, Minnesota, 미국, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, 미국, 39216-4505
        • University Of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, 미국, 65203
        • University of Missouri - Columbia
      • Kansas City, Missouri, 미국, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, 미국, 63110
        • St. Louis Children's Hospital
      • Saint Louis, Missouri, 미국, 63104
        • Cardinal Glennon Children's Hospital
    • Nebraska
      • Omaha, Nebraska, 미국, 68114
        • Children's Hospital of Omaha
      • Omaha, Nebraska, 미국, 68198-2168
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, 미국, 89109
        • Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, 미국, 03756
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, 미국, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, 미국, 07112-2094
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, 미국, 07503
        • St. Joseph's Hospital and Medical Center
      • Summit, New Jersey, 미국, 07901
        • Valerie Fund Children's Center at Atlantic Health
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87131
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Albany, New York, 미국, 12208
        • Children's Hospital at Albany Medical Center
      • Bronx, New York, 미국, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, 미국, 11219
        • Maimonides Medical Center
      • Brooklyn, New York, 미국, 11203
        • SUNY Downstate Medical Center
      • Brooklyn, New York, 미국, 11212
        • Brookdale University Hospital and Medical Center
      • Brooklyn, New York, 미국, 11201-5493
        • Brooklyn Hospital Center
      • Buffalo, New York, 미국, 14263-0001
        • Roswell Park Cancer Institute
      • New Hyde Park, New York, 미국, 11040
        • Schneider Children's Hospital
      • New York, New York, 미국, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, 미국, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • New York, New York, 미국, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • New York, New York, 미국, 10029
        • Mount Sinai Medical Center
      • Rochester, New York, 미국, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Stony Brook, New York, 미국, 11794-8174
        • Long Island Cancer Center at Stony Brook University Hospital
      • Syracuse, New York, 미국, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, 미국, 10595
        • New York Medical College
    • North Carolina
      • Asheville, North Carolina, 미국, 28801
        • Mission Hospitals - Memorial Campus
      • Chapel Hill, North Carolina, 미국, 27599
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, 미국, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, 미국, 28233
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Durham, North Carolina, 미국, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, 미국, 27858-4354
        • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
      • Winston-Salem, North Carolina, 미국, 27157-1081
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Fargo, North Dakota, 미국, 58103-4940
        • Dakota Cancer Institute at Innovis Health - Dakota Clinic
    • Ohio
      • Akron, Ohio, 미국, 44308-1062
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, 미국, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, 미국, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, 미국, 44106-5065
        • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
      • Columbus, Ohio, 미국, 43205-2696
        • Columbus Children's Hospital
      • Dayton, Ohio, 미국, 45404
        • Children's Medical Center - Dayton
      • Toledo, Ohio, 미국, 43601
        • Toledo Children's Hospital
      • Toledo, Ohio, 미국, 43608
        • St. Vincent Mercy Medical Center
      • Youngstown, Ohio, 미국, 44501
        • Tod Children's Hospital - Forum Health
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73104
        • Children's Hospital at Oklahoma University Medical Center
      • Tulsa, Oklahoma, 미국, 74136
        • CCOP - Oklahoma
      • Tulsa, Oklahoma, 미국, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Oregon
      • Portland, Oregon, 미국, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, 미국, 97227
        • Legacy Emanuel Hospital and Health Center & Children's Hospital
      • Portland, Oregon, 미국, 97239-3098
        • Doernbecher Children's Hospital at Oregon Health & Science University
    • Pennsylvania
      • Danville, Pennsylvania, 미국, 17822-1320
        • Geisinger Medical Center
      • Hershey, Pennsylvania, 미국, 17033
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, 미국, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, 미국, 19134-1095
        • St. Christopher's Hospital for Children
      • Pittsburgh, Pennsylvania, 미국, 15213
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, 미국, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, 미국, 29425-0721
        • Hollings Cancer Center at Medical University of South Carolina
      • Columbia, South Carolina, 미국, 29203
        • Palmetto Health South Carolina Cancer Center
      • Greenville, South Carolina, 미국, 29605
        • Children's Hospital of Greenville Hospital System
    • South Dakota
      • Sioux Falls, South Dakota, 미국, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, 미국, 57105-1080
        • Avera Cancer Institute
    • Tennessee
      • Johnson City, Tennessee, 미국, 37614-0622
        • East Tennessee State University Cancer Center at Johnson City Medical Center
      • Knoxville, Tennessee, 미국, 37901
        • East Tennessee Children's Hospital
      • Memphis, Tennessee, 미국, 38105
        • St. Jude Children's Research Hospital
      • Nashville, Tennessee, 미국, 37232-6310
        • Vanderbilt Children's Hospital
    • Texas
      • Amarillo, Texas, 미국, 79106
        • Texas Tech University Health Sciences Center School of Medicine
      • Austin, Texas, 미국, 78701
        • Children's Hospital of Austin
      • Dallas, Texas, 미국, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, 미국, 75390-9063
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, 미국, 76104
        • Cook Children's Medical Center - Fort Worth
      • Galveston, Texas, 미국, 77555-0209
        • University of Texas Medical Branch
      • Houston, Texas, 미국, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
      • Houston, Texas, 미국, 77030
        • Cancer Center at Baylor College of Medicine
      • Lackland Air Force Base, Texas, 미국, 78236-5300
        • Wilford Hall Medical Center
      • Lubbock, Texas, 미국, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, 미국, 78207
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, 미국, 78229-3900
        • MBCCOP - South Texas Pediatrics
      • San Antonio, Texas, 미국, 78229-3902
        • Methodist Cancer Center at Methodist Specialty and Transplant Hospital
      • Temple, Texas, 미국, 76508
        • CCOP - Scott and White Hospital
      • Temple, Texas, 미국, 76508
        • Center for Cancer Prevention and Care at Scott and White Clinic
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • Huntsman Cancer Institute at University of Utah
    • Vermont
      • Burlington, Vermont, 미국, 05401-3498
        • Vermont Cancer Center at University of Vermont
    • Virginia
      • Charlottesville, Virginia, 미국, 22908
        • University of Virginia Cancer Center
      • Falls Church, Virginia, 미국, 22042-3300
        • Inova Fairfax Hospital
      • Norfolk, Virginia, 미국, 23507
        • Children's Hospital of The King's Daughters
      • Portsmouth, Virginia, 미국, 23708-5100
        • Naval Medical Center - Portsmouth
      • Richmond, Virginia, 미국, 23298-0121
        • Massey Cancer Center at Virginia Commonwealth University
      • Roanoke, Virginia, 미국, 24029
        • Carilion Medical Center for Children at Roanoke Community Hospital
    • Washington
      • Seattle, Washington, 미국, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Seattle, Washington, 미국, 98109-1024
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, 미국, 98112
        • Group Health Central Hospital
      • Spokane, Washington, 미국, 99210-0248
        • Deaconess Medical Center
      • Tacoma, Washington, 미국, 98415-0299
        • Mary Bridge Children's Hospital and Health Center - Tacoma
      • Tacoma, Washington, 미국, 98431-0001
        • Madigan Army Medical Center
    • West Virginia
      • Charleston, West Virginia, 미국, 25302
        • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
      • Huntington, West Virginia, 미국, 25701
        • Cabell Huntington Hospital
      • Morgantown, West Virginia, 미국, 26506-9300
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, 미국, 54301
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • Green Bay, Wisconsin, 미국, 54301
        • Bellin Memorial Hospital
      • Green Bay, Wisconsin, 미국, 54307-9070
        • St. Vincent Hospital
      • La Crosse, Wisconsin, 미국, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, 미국, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield, Wisconsin, 미국, 54449
        • CCOP - Marshfield Clinic Research Foundation
      • Marshfield, Wisconsin, 미국, 54449-5772
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, 미국, 53226
        • Midwest Children's Cancer Center
  • 스위스
      • Bern, 스위스, CH 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, 스위스, CH 1211
        • Swiss Pediatric Oncology Group Geneva
      • Lausanne, 스위스, CH 1011
        • Swiss Pediatric Oncology Group Lausanne
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2T 5C7
        • Alberta Children's Hospital
      • Edmonton, Alberta, 캐나다, T6G 1Z2
        • Cross Cancer Institute at University of Alberta
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, 캐나다, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, 캐나다, A1B 3V6
        • Janeway Children's Health and Rehabilitation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다, NS B3J 3G9
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, 캐나다, L8S 4J9
        • McMaster Children's Hospital at Hamilton Health Sciences
      • London, Ontario, 캐나다, N6C 2V5
        • Children's Hospital of Western Ontario
      • Ottawa, Ontario, 캐나다, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, 캐나다, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, 캐나다, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
      • Montreal, Quebec, 캐나다, H3T 1C5
        • Hopital Sainte Justine
      • Sainte Foy, Quebec, 캐나다, GIV 4G2
        • Centre de Recherche du Centre Hospitalier de l'Universite Laval
    • Saskatchewan
      • Regina, Saskatchewan, 캐나다, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, 캐나다, S7N 4H4
        • Saskatoon Cancer Centre
  • 푸에르토 리코
      • San Juan, 푸에르토 리코, 00936-5067
        • Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
      • Santurce, 푸에르토 리코, 00912
        • San Jorge Children's Hospital
  • 호주
    • New South Wales
      • Randwick, New South Wales, 호주, 2031
        • Sydney Children's Hospital
      • Westmead, New South Wales, 호주, 2145
        • Children's Hospital at Westmead
    • Queensland
      • Brisbane, Queensland, 호주, 4029
        • Royal Children's Hospital
    • South Australia
      • North Adelaide, South Australia, 호주, 5006
        • Women's and Children's Hospital
    • Victoria
      • Parkville, Victoria, 호주, 3052
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, 호주, 6001
        • Princess Margaret Hospital for Children

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 이하 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

DISEASE CHARACTERISTICS:

  • Histologically proven neuroblastoma or maturing ganglioneuroma that is judged to be intermediate risk by one of the following criteria:

    • International Neuroblastoma Staging System (INSS) stage III

      • Under 1 year old, MYCN oncogene nonamplified, and any ploidy
      • 1 to 20 years old, MYCN nonamplified, favorable Shimada histology

    • INSS stage IV

      • Under 1 year old, MYCN nonamplified, any ploidy

    • INSS stage IVS

      • Under 1 year old, MYCN nonamplified, unfavorable Shimada histology and any ploidy OR favorable Shimada histology and diploidy
  • All patients must be registered on the companion neuroblastoma biology study (COG-ANBL00B1)

PATIENT CHARACTERISTICS:

Age:

  • Under 21

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No abnormal organ function that would prohibit chemotherapy unless due to neuroblastoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior chemotherapy for patients with intradural extension and emergent paresis allowed provided biopsy was performed within 96 hours after treatment

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No other prior therapy

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 치료
자세한 설명을 참조하십시오.
의약품: 카보플라틴
다른 이름들:
  • 파라플라틴
  • NSC-241240
의약품: 사이클로포스파마이드
다른 이름들:
  • 사이톡산
  • NSC-26271
의약품: 에토포사이드
다른 이름들:
  • VP-16
  • 베페시드
  • NSC-141540
절차: 신 보조 요법
의약품: 독소루비신 염산염
다른 이름들:
  • 아드리아마이신
  • NSC-123127
절차: 기존 수술
생물학적: 필그라스팀
다른 이름들:
  • G-CSF
  • 과립구 콜로니 자극 인자
  • r-metHuG-CSF
  • NSC #614629
  • 뉴포젠®
생물학적: 사르그라모스팀
다른 이름들:
  • 류킨
  • 프로킨
  • GM-CSF
  • 과립구 대식세포 콜로니 자극 인자
  • 류 GM-CSF
  • NSC #613795

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
이벤트 프리 서바이벌

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Children's Oncology Group

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: David L. Baker, MD, MBBS, FRACP, FRCPA, Princess Margaret Hospital for Children

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

1988년 3월 1일

기본 완료 (실제)

2006년 9월 1일

연구 완료 (실제)

2011년 1월 1일

연구 등록 날짜

최초 제출

1999년 11월 1일

QC 기준을 충족하는 최초 제출

2003년 1월 26일

처음 게시됨 (추정)

2003년 1월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 8월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 7월 31일

마지막으로 확인됨

2014년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A3961
  • COG-A3961 (기타 식별자: Children's Oncology Group)
  • CCG-A3961 (기타 식별자: Children's Cancer Group)
  • POG-A3961 (기타 식별자: Pediatric Oncology Group)
  • CDR0000065804 (기타 식별자: Clinical Trials.gov)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

카보플라틴에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Slovenia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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