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Kombinationskemoterapi med eller uden strålebehandling til behandling af unge patienter med nydiagnosticeret trin III eller trin IV Wilms' tumor

8. juli 2026 opdateret af: Children's Oncology Group

Behandling af nydiagnosticerede gunstige histologiske Wilms-tumorer med højere risiko

Dette fase III-forsøg undersøger, hvor godt kombinationskemoterapi med eller uden strålebehandling virker ved behandling af unge patienter med nydiagnosticeret stadium III eller stadium IV Favorable Histology Wilms' tumor. Lægemidler, der bruges i kemoterapi, virker på forskellige måder for at stoppe væksten af ​​tumorceller, enten ved at dræbe cellerne eller ved at forhindre dem i at dele sig. Strålebehandling bruger højenergi røntgenstråler til at dræbe tumorceller. At give mere end ét lægemiddel (kombinationskemoterapi) med eller uden strålebehandling kan dræbe flere tumorceller.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMÆRE MÅL:

I. Bestem 4-års hændelsesfri overlevelse (EFS) for patienter med fase IV favorabel histologi (FH) Wilms' tumor med kun lungemetastaser, som har fuldstændig opløsning af pulmonale læsioner uden hellungebestråling behandlet med DD4A kemoterapi omfattende vincristin, dactinomycin og doxorubicinhydrochlorid.

II. Bestem 4-års EFS for disse patienter, som ikke har opløsning af lungemetastaser inden uge 6, behandlet med tilføjelse af cyclophosphamid og etoposid til et modificeret regimen DD4A (regime M).

III. Bestem den 4-årige EFS for patienter med stadium III eller IV FH Wilms' tumor med tab af heterozygositet for kromosomerne 1p og 16q behandlet med regimen M.

SEKUNDÆRE MÅL:

I. Korrelér byrden af ​​lungemetastatisk sygdom med udfald hos patienter med stadium IV FH Wilms' tumor.

OVERSIGT: Dette er en multicenterundersøgelse.

REGIMEN DD4A (uge 1-6): Patienter får dactinomycin IV over 1-5 minutter én gang i uge 1; vincristin IV én gang i uge 1-6; og doxorubicin hydrochlorid IV over 15 minutter én gang i uge 4 i fravær af sygdomsprogression eller uacceptabel toksicitet. Patienter med både lunge- og ekstrapulmonale metastaser ved diagnosen gennemgår strålebehandling én gang dagligt begyndende i uge 1 og fortsætter i 5-14 dage. Efter afslutning af DD4A-kemoterapi (uge 6) gennemgår patienterne evaluering. Patienter med stadium IV-sygdom og kun lungemetastaser uden tab af heterozygositet (LOH), som er hurtige fuldstændige respondere (RCR) (dvs. alle lungemetastaser forsvinder) fortsætter til regimen DD4A (uge 7-25).

Alle andre patienter (dvs. patienter med stadium III eller IV sygdom og LOH på både 1p og 16q; stadium IV sygdom med kun lungemetastaser, som er langsomt inkomplet respondere [SIR] [dvs. lungemetastaser forsvinder ikke]; eller stadium IV sygdom med nonpulmonale metastaser eller med nonpulmonale metastaser i kombination med pulmonale metastaser fortsæt til regime M (uge 7-31).

Patienter med initialt ikke-operable eller ufuldstændige resekterede tumorer revurderes i uge 6, og hvis de er resecerbare, gennemgår de operation og fortsætter derefter til enten regimen DD4A eller regimen M som beskrevet ovenfor.

REGIMEN DD4A (uge 7-25): Patienter får dactinomycin IV over 1-5 minutter én gang i uge 7, 13, 19 og 25; vincristin IV én gang i uge 7-10, 13, 16, 19, 22 og 25; og doxorubicinhydrochlorid IV over 15 minutter én gang i uge 10, 16 og 22 i fravær af sygdomsprogression eller uacceptabel toksicitet.

REGIMEN M (uge 7-31): Patienterne får cyclophosphamid IV over 1 time og etoposid IV over 1 time på dag 1-5 i uge 7, 10, 19 og 25; vincristin IV én gang i uge 8, 9, 11, 12, 13, 16, 22, 28 og 31; og dactinomycin IV eller doxorubicin hydrochlorid IV over 15 minutter én gang i uge 13, 16, 22, 28 og 31 i fravær af sygdomsprogression eller uacceptabel toksicitet. Patienter med kun lungemetastaser, som er SIR, gennemgår også hellungestrålebehandling én gang dagligt begyndende i uge 7 og fortsætter i 5-14 dage.

BEMÆRK: Patienter, der begynder undersøgelsesbehandling efter at have gennemgået resektion af alle lungemetastaser, er ikke kvalificerede til denne undersøgelse. Det anbefales, at disse patienter behandles i henhold til den nuværende guldstandard for terapi, som er kemoterapi i henhold til regimen DD4A (uge 1-25) og strålebehandling af hele lungerne i 5-14 dage begyndende i uge 1.

Efter afslutning af studiebehandlingen følges patienterne periodisk i 10 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

395

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • New South Wales
      • Randwick, New South Wales, Australien, 2031
        • Sydney Children's Hospital
      • Westmead, New South Wales, Australien, 2145
        • The Children's Hospital at Westmead
    • Queensland
      • Herston, Queensland, Australien, 4029
        • Royal Brisbane and Women's Hospital
      • Herston, Queensland, Australien, 4029
        • Royal Children's Hospital-Brisbane
      • South Brisbane, Queensland, Australien, 4101
        • Queensland Children's Hospital
    • South Australia
      • North Adelaide, South Australia, Australien, 5006
        • Women's and Children's Hospital-Adelaide
    • Victoria
      • Parkville, Victoria, Australien, 3052
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australien, 6008
        • Princess Margaret Hospital for Children
  • Canada
      • Québec, Canada, G1V 4G2
        • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • 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 Child Health Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
      • London, Ontario, Canada, N6A 5W9
        • Children's Hospital
      • London, Ontario, Canada, N6K 1C2
        • Victoria Hospital
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • The Montreal Children's Hospital of the MUHC
      • Montreal, Quebec, Canada, H3T 1C5
        • Centre Hospitalier Universitaire Sainte-Justine
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama at Birmingham Cancer Center
      • Birmingham, Alabama, Forenede Stater, 35233
        • Children's Hospital of Alabama
      • Mobile, Alabama, Forenede Stater, 36604
        • USA Health Strada Patient Care Center
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
        • Phoenix Childrens Hospital
      • Tucson, Arizona, Forenede Stater, 85719
        • Banner University Medical Center - Tucson
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Forenede Stater, 72202-3591
        • Arkansas Children's Hospital
    • California
      • Downey, California, Forenede Stater, 90242
        • Kaiser Permanente Downey Medical Center
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Medical Center
      • Long Beach, California, Forenede Stater, 90806
        • Miller Children's and Women's Hospital Long Beach
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Forenede Stater, 90027
        • Children's Hospital Los Angeles
      • Madera, California, Forenede Stater, 93636
        • Valley Children's Hospital
      • Oakland, California, Forenede Stater, 94609
        • UCSF Benioff Children's Hospital Oakland
      • Oakland, California, Forenede Stater, 94611
        • Kaiser Permanente-Oakland
      • Oakland, California, Forenede Stater, 94607
        • Children's Oncology Group
      • Orange, California, Forenede Stater, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, Forenede Stater, 94304
        • Lucile Packard Children's Hospital Stanford University
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Comprehensive Cancer Center
      • San Diego, California, Forenede Stater, 92123
        • Rady Children's Hospital - San Diego
      • San Francisco, California, Forenede Stater, 94158
        • UCSF Medical Center-Mission Bay
      • San Francisco, California, Forenede Stater, 94143
        • UCSF Medical Center-Parnassus
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Children's Hospital Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06030
        • University of Connecticut
      • Hartford, Connecticut, Forenede Stater, 06106
        • Connecticut Children's Medical Center
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19803
        • Alfred I duPont Hospital for Children
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20010
        • Children's National Medical Center
      • Washington D.C., District of Columbia, Forenede Stater, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Broward Health Medical Center
      • Fort Myers, Florida, Forenede Stater, 33908
        • Golisano Children's Hospital of Southwest Florida
      • Fort Myers, Florida, Forenede Stater, 33901
        • Lee Memorial Health System
      • Gainesville, Florida, Forenede Stater, 32610
        • UF Health Cancer Institute - Gainesville
      • Hollywood, Florida, Forenede Stater, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Jacksonville, Florida, Forenede Stater, 32207
        • Nemours Children's Clinic-Jacksonville
      • Miami, Florida, Forenede Stater, 33155
        • Nicklaus Children's Hospital
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, Forenede Stater, 33176
        • Miami Cancer Institute
      • Orlando, Florida, Forenede Stater, 32806
        • Orlando Health Cancer Institute
      • Orlando, Florida, Forenede Stater, 32806
        • Nemours Children's Clinic - Orlando
      • Orlando, Florida, Forenede Stater, 32803
        • AdventHealth Orlando
      • Orlando, Florida, Forenede Stater, 32806
        • Arnold Palmer Hospital for Children
      • Pensacola, Florida, Forenede Stater, 32504
        • Sacred Heart Hospital
      • Pensacola, Florida, Forenede Stater, 32504
        • Nemours Children's Clinic - Pensacola
      • St. Petersburg, Florida, Forenede Stater, 33701
        • Johns Hopkins All Children's Hospital
      • Tampa, Florida, Forenede Stater, 33607
        • Saint Joseph's Hospital/Children's Hospital-Tampa
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Saint Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, Forenede Stater, 30329
        • Children's Healthcare of Atlanta - Arthur M Blank Hospital
      • Savannah, Georgia, Forenede Stater, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Forenede Stater, 96859
        • Tripler Army Medical Center
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • Saint Luke's Cancer Institute - Boise
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Lurie Children's Hospital-Chicago
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Advocate Children's Hospital-Oak Lawn
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Advocate Lutheran General Hospital
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Advocate Children's Hospital-Park Ridge
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF Children's Hospital of Illinois
      • Springfield, Illinois, Forenede Stater, 62702
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Riley Hospital for Children
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Ascension Saint Vincent Indianapolis Hospital
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Cancer Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, Forenede Stater, 40202
        • Norton Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, Forenede Stater, 70118
        • Children's Hospital New Orleans
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Eastern Maine Medical Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, Forenede Stater, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Bethesda, Maryland, Forenede Stater, 20889-5600
        • Walter Reed National Military Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Children's Hospital
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Medical Center
      • Worcester, Massachusetts, Forenede Stater, 01655
        • UMass Memorial Medical Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • C S Mott Children's Hospital
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, Forenede Stater, 48236
        • Henry Ford Health Saint John Hospital
      • East Lansing, Michigan, Forenede Stater, 48823
        • Michigan State University
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49008
        • Kalamazoo Center for Medical Studies
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Corewell Health William Beaumont University Hospital
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Corewell Health Children's
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota/Masonic Cancer Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65212
        • University of Missouri Children's Hospital
      • Columbia, Missouri, Forenede Stater, 65212
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Kansas City, Missouri, Forenede Stater, 64108
        • Children's Mercy Hospitals and Clinics
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Forenede Stater, 63104
        • Cardinal Glennon Children's Medical Center
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Forenede Stater, 68114
        • Children's Hospital and Medical Center of Omaha
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Forenede Stater, 89120
        • Nevada Cancer Research Foundation NCORP
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, Forenede Stater, 07960
        • Morristown Medical Center
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Saint Peter's University Hospital
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
      • Newark, New Jersey, Forenede Stater, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, Forenede Stater, 07503
        • Saint Joseph's Regional Medical Center
      • Summit, New Jersey, Forenede Stater, 07902
        • Overlook Hospital
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • University of New Mexico Cancer Center
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Albany Medical Center
      • Brooklyn, New York, Forenede Stater, 11201
        • Brooklyn Hospital Center
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • Mineola, New York, Forenede Stater, 11501
        • NYU Langone Hospital - Long Island
      • New Hyde Park, New York, Forenede Stater, 11040
        • The Steven and Alexandra Cohen Children's Medical Center of New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Forenede Stater, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, Forenede Stater, 10065
        • NYP/Weill Cornell Medical Center
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
      • Stony Brook, New York, Forenede Stater, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, Forenede Stater, 13210
        • State University of New York Upstate Medical University
      • The Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center - Moses Campus
      • Valhalla, New York, Forenede Stater, 10595
        • New York Medical College
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Hospital
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Novant Health Presbyterian Medical Center
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, Forenede Stater, 27834
        • East Carolina University
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44308
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Forenede Stater, 44106
        • Rainbow Babies and Childrens Hospital
      • Columbus, Ohio, Forenede Stater, 43205
        • Nationwide Children's Hospital
      • Dayton, Ohio, Forenede Stater, 45404
        • Dayton Children's Hospital
      • Toledo, Ohio, Forenede Stater, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo
      • Toledo, Ohio, Forenede Stater, 43608
        • Mercy Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Natalie Warren Bryant Cancer Center at Saint Francis
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Children's Hospital
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Hospital and Health Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forenede Stater, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19134
        • Saint Christopher's Hospital for Children
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Children's Hospital of Pittsburgh of UPMC
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Prisma Health Richland Hospital
      • Greenville, South Carolina, Forenede Stater, 29605
        • BI-LO Charities Children's Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Cancer Treatment Center
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • T C Thompson Children's Hospital
      • Knoxville, Tennessee, Forenede Stater, 37916
        • East Tennessee Childrens Hospital
      • Memphis, Tennessee, Forenede Stater, 38105
        • Saint Jude Children's Research Hospital
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Texas Tech University Health Sciences Center-Amarillo
      • Austin, Texas, Forenede Stater, 78723
        • Dell Children's Medical Center of Central Texas
      • Corpus Christi, Texas, Forenede Stater, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, Forenede Stater, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, Forenede Stater, 75230
        • Medical City Dallas Hospital
      • Fort Sam Houston, Texas, Forenede Stater, 78234
        • Brooke Army Medical Center
      • Fort Worth, Texas, Forenede Stater, 76104
        • Cook Children's Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Lubbock, Texas, Forenede Stater, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, Forenede Stater, 78229
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forenede Stater, 78229
        • Methodist Children's Hospital of South Texas
      • Temple, Texas, Forenede Stater, 76508
        • Scott and White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84113
        • Primary Children's Hospital
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05405
        • University of Vermont and State Agricultural College
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia Cancer Center
      • Falls Church, Virginia, Forenede Stater, 22042
        • INOVA Fairfax Hospital
      • Norfolk, Virginia, Forenede Stater, 23507
        • Children's Hospital of The King's Daughters
      • Richmond, Virginia, Forenede Stater, 23298
        • VCU Massey Comprehensive Cancer Center
      • Roanoke, Virginia, Forenede Stater, 24014
        • Carilion Children's
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Seattle Children's Hospital
      • Spokane, Washington, Forenede Stater, 99204
        • Providence Sacred Heart Medical Center and Children's Hospital
      • Tacoma, Washington, Forenede Stater, 98405
        • Mary Bridge Children's Hospital and Health Center
      • Tacoma, Washington, Forenede Stater, 98431
        • Madigan Army Medical Center
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • West Virginia University Charleston Division
      • Huntington, West Virginia, Forenede Stater, 25701
        • Cabell-Huntington Hospital
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Children's Hospital of Wisconsin
  • Israel
      • Petah Tikua, Israel, 49202
        • Schneider Children's Medical Center of Israel
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1145
        • Starship Children's Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00912
        • San Jorge Children's Hospital
  • Schweiz
      • Bern, Schweiz, 3010
        • Swiss Pediatric Oncology Group - Bern

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 29 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Nydiagnosticeret Wilms' tumor opfylder 1 af følgende kriterier:

    • Stadie IV sygdom med gunstig histologi med eller uden tab af heterozygositet (LOH) for 1p og 16q
    • Stadie III sygdom med gunstig histologi med LOH for 1p og 16q overførsel fra klinisk forsøg COG-AREN0532
  • Patienter skal påbegynde behandlingen inden for 14 dage efter operation eller biopsi, medmindre det er medicinsk kontraindiceret

  • Ingen bilaterale Wilms' tumorer (stadium IV)

    • Patienter skal henvises til COG-AREN0534
  • Tidligere tilmeldt klinisk forsøg COG-AREN03B2
  • Karnofsky præstationsstatus (PS) 50-100 % (for patienter > 16 år) ELLER Lansky PS 50-100 % (for patienter ≤ 16 år)
  • Bilirubin ≤ 1,5 gange øvre normalgrænse (ULN)
  • AST eller ALT < 2,5 gange ULN
  • Afkortningsfraktion ≥ 27 % ved ekkokardiogram ELLER ejektionsfraktion ≥ 50 % ved radionuklidangiogram
  • Ikke gravid eller ammende
  • Negativ graviditetstest
  • Fertile patienter skal bruge effektiv prævention
  • Ingen tidligere tumor-styret kemoterapi eller strålebehandling, medmindre overførsel fra klinisk forsøg COG-AREN0532 ELLER behandling for nye problemer, som medicinsk indiceret
  • Ingen samtidig aprepitant

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Behandling (kemoterapi, kirurgi, strålebehandling)

REGIMEN DD4A (uge 1-6): Patienter får dactinomycin IV; vincristin IV; og doxorubicinhydrochlorid IV. Patienter med lunge- og ekstrapulmonale metastaser ved diagnosen gennemgår strålebehandling.

Patienter med initialt ikke-operable eller ufuldstændige resekerede tumorer revurderes i uge 6, og hvis de er resecerbare, gennemgår de en operation og fortsætter derefter til enten regimen DD4A eller regimen M.

REGIMEN DD4A (uge 7-25): Patienter får dactinomycin IV; vincristin IV; og doxorubicinhydrochlorid IV.

REGIMEN M (uge 7-31): Patienter får cyclophosphamid IV; vincristin IV; og dactinomycin IV og doxorubicinhydrochlorid IV. Patienter med kun lungemetastaser, som er SIR, gennemgår også hellungestrålebehandling.
Medicin: Etoposid
Givet IV
Andre navne:
  • Demethyl Epipodophyllotoxin Ethylidin Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP 16213
  • VP-16213
  • VP16213
Medicin: Cyclofosfamid
Givet IV
Andre navne:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamid
  • 2H-1,3,2-Oxazaphosphorin, 2-[bis(2-chlorethyl)amino]tetrahydro-, 2-oxid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Cykloblastin
  • Cycloblastin
  • Cyclofosfam
  • Cyclophosphamid monohydrat
  • Cyclophosphamid Monohydrat
  • Cyclophospamidum
  • Cyclofosfan
  • Cyclophosphanum
  • Cyclostin
  • Cytophosphan
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Medicin: Doxorubicin Hydrochlorid
Givet IV
Andre navne:
  • Adriamycin
  • 5,12-naphthacendion, 10-[(3-amino-2,3,6-trideoxy-alfa-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy -8-(hydroxyacetyl)-1-methoxy-, hydrochlorid, (8S-cis)- (9Cl)
  • ADM
  • Adriacin
  • Adriamycin hydrochlorid
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORID
  • Adriblastina
  • Adriblastin
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
  • FI106
Biologisk: Dactinomycin
Givet IV
Andre navne:
  • Cosmegen
  • Actinomycin A IV
  • Actinomycin C1
  • Actinomycin I1
  • Actinomycin IV
  • Actinomycin X 1
  • Actinomycin-[thr-val-pro-sar-meval]
  • DACT
  • Dactinomycin
  • Lyovac Cosmegen
  • Meractinomycin
  • Actinomycin D
Stråling: 3-dimensionel konform strålebehandling
Andre navne:
  • 3-dimensionel strålebehandling
  • 3D KONFORMAL STRÅLETERAPI
  • 3D CRT
  • 3D-CRT
  • Konform terapi
  • Stråling konform terapi
  • 3D konform
  • Stråling, 3D-konform
  • 3D strålebehandling
  • Tredimensionel ekstern strålebehandling (procedure)
Procedure: Konventionel kirurgi
Medicin: Vincristin sulfat liposom
Givet IV
Andre navne:
  • Marqibo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Begivenhedsfri overlevelsessandsynlighed
Tidsramme: 4 år
Sandsynlighed for intet tilbagefald, sekundær malignitet eller død efter 4 år i undersøgelsen.
4 år
Event Free Survival (EFS) Sandsynlighed
Tidsramme: På 4 år
Sandsynlighed for intet tilbagefald, sekundær malignitet eller død efter 4 år i undersøgelsen.
På 4 år
Begivenhedsfri overlevelsessandsynlighed
Tidsramme: På 4 år
Sandsynlighed for intet tilbagefald, sekundær malignitet eller død efter 4 år i undersøgelsen
På 4 år

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Begivenhedsfri overlevelse forbundet med byrden af ​​lungemetastatisk sygdom
Tidsramme: På 4 år
Sandsynlighed for intet tilbagefald, sekundær malignitet eller død efter 4 år i undersøgelsen.
På 4 år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Elizabeth A Mullen, Children's Oncology Group

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. april 2007

Primær færdiggørelse (Faktiske)

30. juni 2016

Studieafslutning (Faktiske)

31. marts 2026

Datoer for studieregistrering

Først indsendt

19. september 2006

Først indsendt, der opfyldte QC-kriterier

19. september 2006

Først opslået (Anslået)

21. september 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AREN0533 (Anden identifikator: CTEP)
  • U10CA180886 (U.S. NIH-bevilling/kontrakt)
  • U10CA098543 (U.S. NIH-bevilling/kontrakt)
  • NCI-2009-00419 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000496508 (Clinical Trials.gov)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner