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Pazopanib hydrochlorid til behandling af patienter med metastatisk nyrekræft, som ikke har tegn på sygdom efter operation

28. maj 2026 opdateret af: National Cancer Institute (NCI)

Randomiseret, dobbeltblindet fase III-studie af Pazopanib vs. Placebo hos patienter med metastatisk nyrecellecarcinom, som ikke har tegn på sygdom efter metastatektomi

Dette randomiserede fase III-studie undersøger, hvor godt pazopanibhydrochlorid virker sammenlignet med placebo til behandling af patienter med nyrekræft, som har spredt sig til andre dele af kroppen og ikke har tegn på sygdom efter operationen. Pazopanibhydrochlorid kan stoppe væksten af ​​tumorceller ved at blokere nogle af de enzymer, der er nødvendige for cellevækst, og ved at blokere blodgennemstrømningen til tumoren.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMÆRE MÅL:

I. At evaluere sygdomsfri overlevelse med pazopanib (pazopanib hydrochlorid) sammenlignet med placebo, defineret som tiden fra randomisering til udvikling af tilbagevendende sygdom, anden primær cancer (bortset fra lokaliseret brystkræft, lokaliseret prostata eller ikke-melanom hudkræft ) eller død af enhver årsag for patienter med metastatisk nyrecellecarcinom (RCC) uden tegn på sygdom efter metastasektomi.

SEKUNDÆRE MÅL:

I. At beskrive den samlede overlevelse af patienter med fremskreden RCC tilfældigt tildelt placebo eller pazopanib i et år efter metastasektomi uden tegn på sygdom (NED).

II. At beskrive behandling og (ved tilbagefald) sygdomsrelaterede bivirkninger i de to behandlingsarme.

III. At analysere kvalitetsjusteret tid uden symptomer på sygdom eller behandling (Q-TWiST) for forsøgspersoner i de to behandlingsarme.

IV. At karakterisere ændringer i patientrapporteret træthed og (ved tilbagefald) nyrekræftrelaterede symptomer under og efter behandling med pazopanib sammenlignet med placebo.

V. At udforske sammenhængen mellem plasma-dalniveauer af pazopanib og sygdomsfri og samlet overlevelse.

VI. At prospektivt banke konserveret væv fra primære tumorer og associerede metastatiske steder hos patienter med RCC.

OVERSIGT: Patienterne randomiseres til 1 af 2 behandlingsarme.

ARM A: Patienterne får pazopanibhydrochlorid oralt (PO) én gang dagligt (QD) på dag 1-28. Behandlingen gentages hver 28. dag i op til 13 kure i fravær af sygdomsprogression eller uacceptabel toksicitet.

ARM B: Patienter modtager placebo PO QD på dag 1-28. Behandlingen gentages hver 28. dag i op til 13 kure i fravær af sygdomsprogression eller uacceptabel toksicitet.

Efter afsluttet undersøgelsesbehandling følges patienterne op hver 3. måned i de første to år, hver 6. måned i de næste 3 år og derefter årligt op til 10 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

129

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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    • Alaska
      • Fairbanks, Alaska, Forenede Stater, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85704
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      • Effingham, Illinois, Forenede Stater, 62401
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        • Radiation Oncology of Northern Illinois
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        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, Forenede Stater, 61554
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        • OSF Saint Francis Radiation Oncology at Pekin
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        • Methodist Medical Center of Illinois
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        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, Forenede Stater, 61615
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Peoria, Illinois, Forenede Stater, 61614
        • Proctor Hospital
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, Forenede Stater, 61354
        • Valley Radiation Oncology
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        • Illinois Valley Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Illinois CancerCare-Princeton
      • Skokie, Illinois, Forenede Stater, 60076
        • Hematology Oncology Associates of Illinois - Skokie
      • Springfield, Illinois, Forenede Stater, 62702
        • Southern Illinois University School of Medicine
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        • Springfield Clinic
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        • Central Illinois Hematology Oncology Center
      • Springfield, Illinois, Forenede Stater, 62781
        • Springfield Memorial Hospital
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        • Southwest Illinois Health Services LLP
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
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      • Ames, Iowa, Forenede Stater, 50010
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        • Cancer Center of Kansas - Dodge City
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        • Cancer Center of Kansas - El Dorado
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        • Newman Regional Health
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        • Cancer Center of Kansas - Fort Scott
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        • HaysMed
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        • Cancer Center of Kansas-Independence
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        • Cancer Center of Kansas - Pratt
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        • Cancer Center of Kansas - Salina
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        • Cancer Center of Kansas - Winfield
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        • Flaget Memorial Hospital
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        • Commonwealth Cancer Center-Corbin
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        • Hope Cancer Center
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        • Newland Medical Associates-Pontiac
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        • Michigan Healthcare Professionals Pontiac
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        • Henry Ford Rochester Hospital
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        • Michigan Cancer Specialists
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Cancer Care Associates PC
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Comprehensive Medical Center PLLC
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Oakland Medical Group
      • Royal Oak, Michigan, Forenede Stater, 48067
        • Oakland Colon Rectal Associates
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Hematology Oncology Consultants PC-Royal Oak
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Corewell Health William Beaumont University Hospital
      • Saginaw, Michigan, Forenede Stater, 48604
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, Forenede Stater, 48601
        • MyMichigan Medical Center Saginaw
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Sterling Heights, Michigan, Forenede Stater, 48312
        • Bhadresh Nayak MD PC-Sterling Heights
      • Sterling Heights, Michigan, Forenede Stater, 48312
        • Premier Hematology Oncology Care
      • Sterling Heights, Michigan, Forenede Stater, 48314
        • Mitchell Folbe MD PC
      • Traverse City, Michigan, Forenede Stater, 49684
        • Munson Medical Center
      • Troy, Michigan, Forenede Stater, 48084
        • Michigan Institute of Urology-Town Center
      • Troy, Michigan, Forenede Stater, 48085
        • Claudia BR Herke MD PC
      • Troy, Michigan, Forenede Stater, 48098
        • Hematology Oncology Consultants PC-Troy
      • Troy, Michigan, Forenede Stater, 48085
        • Corewell Health Beaumont Troy Hospital
      • Warren, Michigan, Forenede Stater, 48088
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, Forenede Stater, 48093
        • Macomb Hematology Oncology PC
      • Warren, Michigan, Forenede Stater, 48093
        • Henry Ford Madison Heights Hospital - Breast
      • Warren, Michigan, Forenede Stater, 48093
        • Henry Ford Health Warren Hospital
      • Warren, Michigan, Forenede Stater, 48093
        • Henry Ford Warren Hospital - GLCMS
      • West Bloomfield, Michigan, Forenede Stater, 48322
        • Henry Ford West Bloomfield Hospital
      • West Branch, Michigan, Forenede Stater, 48661
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Wyoming, Michigan, Forenede Stater, 49519
        • University of Michigan Health - West
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
      • Ypsilanti, Michigan, Forenede Stater, 48106
        • Huron Gastroenterology PC
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Saint Cloud Hospital
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Ballwin, Missouri, Forenede Stater, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, Forenede Stater, 65613
        • Central Care Cancer Center - Bolivar
      • Bonne Terre, Missouri, Forenede Stater, 63628
        • Parkland Health Center-Bonne Terre
      • Branson, Missouri, Forenede Stater, 65616
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Chesterfield, Missouri, Forenede Stater, 63017
        • Saint Luke's Hospital
      • Columbia, Missouri, Forenede Stater, 65212
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Jefferson City, Missouri, Forenede Stater, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, Forenede Stater, 64804
        • Freeman Health System
      • Joplin, Missouri, Forenede Stater, 64804
        • Mercy Hospital Joplin
      • Kansas City, Missouri, Forenede Stater, 64154
        • University of Kansas Cancer Center - North
      • Kansas City, Missouri, Forenede Stater, 64131
        • The University of Kansas Cancer Center-South
      • Kansas City, Missouri, Forenede Stater, 64108
        • University Health Truman Medical Center
      • Lee's Summit, Missouri, Forenede Stater, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • Rolla, Missouri, Forenede Stater, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Forenede Stater, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Sainte Genevieve, Missouri, Forenede Stater, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, Forenede Stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Forenede Stater, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Forenede Stater, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Forenede Stater, 63141
        • Saint Louis-Cape Girardeau CCOP
      • Sullivan, Missouri, Forenede Stater, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, Forenede Stater, 63127
        • BJC Outpatient Center at Sunset Hills
      • Washington, Missouri, Forenede Stater, 63090
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, Forenede Stater, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, Forenede Stater, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, Forenede Stater, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, Forenede Stater, 59102
        • Montana Cancer Consortium NCORP
      • Billings, Montana, Forenede Stater, 59102
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Health Deaconess Hospital
      • Butte, Montana, Forenede Stater, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Forenede Stater, 59405
        • Benefis Sletten Cancer Institute
      • Helena, Montana, Forenede Stater, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Medical Oncology
      • Kalispell, Montana, Forenede Stater, 59901
        • Logan Health Medical Center
      • Missoula, Montana, Forenede Stater, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Forenede Stater, 59802
        • Montana Cancer Specialists
      • Missoula, Montana, Forenede Stater, 59804
        • Community Medical Center
    • Nebraska
      • Grand Island, Nebraska, Forenede Stater, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Kearney, Nebraska, Forenede Stater, 68847
        • CHI Health Good Samaritan
      • Kearney, Nebraska, Forenede Stater, 68845
        • Fred and Pamela Buffett Cancer Center - Kearney
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Saint Elizabeth Regional Medical Center
      • Omaha, Nebraska, Forenede Stater, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Forenede Stater, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Forenede Stater, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, Forenede Stater, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, Forenede Stater, 68131
        • Creighton University Medical Center
      • Omaha, Nebraska, Forenede Stater, 68122
        • Hematology and Oncology Consultants PC
      • Papillion, Nebraska, Forenede Stater, 68046
        • Midlands Community Hospital
    • Nevada
      • Carson City, Nevada, Forenede Stater, 89703
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, Forenede Stater, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Forenede Stater, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Forenede Stater, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Forenede Stater, 89074
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Forenede Stater, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Forenede Stater, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Forenede Stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Cancer and Blood Specialists-Shadow
      • Las Vegas, Nevada, Forenede Stater, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Forenede Stater, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Forenede Stater, 89121
        • Cancer Therapy and Integrative Medicine
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Cancer and Blood Specialists-Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Forenede Stater, 89149
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Forenede Stater, 89169
        • University Cancer Center
      • Las Vegas, Nevada, Forenede Stater, 89120
        • Nevada Cancer Research Foundation NCORP
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, Forenede Stater, 89183
        • OptumCare Cancer Care at Fort Apache
      • Reno, Nevada, Forenede Stater, 89502
        • Renown Regional Medical Center
      • Reno, Nevada, Forenede Stater, 89503
        • Saint Mary's Regional Medical Center
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Cooper Hospital University Medical Center
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Middletown, New York, Forenede Stater, 10940
        • Garnet Health Medical Center
      • The Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center-Weiler Hospital
    • North Carolina
      • Asheboro, North Carolina, Forenede Stater, 27203
        • Randolph Hospital
      • Asheville, North Carolina, Forenede Stater, 28803
        • AdventHealth Infusion Center Asheville
      • Burlington, North Carolina, Forenede Stater, 27215
        • Cone Health Cancer Center at Alamance Regional
      • Clinton, North Carolina, Forenede Stater, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Clinton, North Carolina, Forenede Stater, 28328
        • Sampson Radiation Oncology
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Radiation Oncology
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Cone Health Cancer Center
      • Hendersonville, North Carolina, Forenede Stater, 28792
        • AdventHealth Hendersonville
      • Jacksonville, North Carolina, Forenede Stater, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • Jacksonville, North Carolina, Forenede Stater, 28546
        • Onslow Memorial Hospital
      • Kinston, North Carolina, Forenede Stater, 28501
        • ECU Health Oncology Kinston
      • Mebane, North Carolina, Forenede Stater, 27302
        • Cone Heath Cancer Center at Mebane
      • Reidsville, North Carolina, Forenede Stater, 27320
        • Annie Penn Memorial Hospital
      • Winston-Salem, North Carolina, Forenede Stater, 27104
        • Southeast Clinical Oncology Research Consortium NCORP
    • Ohio
      • Belpre, Ohio, Forenede Stater, 45714
        • Strecker Cancer Center-Belpre
      • Centerville, Ohio, Forenede Stater, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, Forenede Stater, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Oncology Hematology Care Inc-Blue Ash
      • Cincinnati, Ohio, Forenede Stater, 45202
        • Oncology Hematology Care Inc-Eden Park
      • Cincinnati, Ohio, Forenede Stater, 45211
        • Oncology Hematology Care Inc-Mercy West
      • Cincinnati, Ohio, Forenede Stater, 45230
        • Oncology Hematology Care Inc-Anderson
      • Cincinnati, Ohio, Forenede Stater, 45236
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati, Ohio, Forenede Stater, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, Forenede Stater, 45255
        • TriHealth Cancer Institute-Anderson
      • Cleveland, Ohio, Forenede Stater, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, Forenede Stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forenede Stater, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Forenede Stater, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, Forenede Stater, 43228
        • Doctors Hospital
      • Columbus, Ohio, Forenede Stater, 43215
        • Grant Medical Center
      • Columbus, Ohio, Forenede Stater, 43222
        • Mount Carmel Health Center West
      • Columbus, Ohio, Forenede Stater, 43215
        • Columbus NCI Community Oncology Research Program
      • Dayton, Ohio, Forenede Stater, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Forenede Stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forenede Stater, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Forenede Stater, 45405
        • Grandview Hospital
      • Dayton, Ohio, Forenede Stater, 45459
        • Dayton NCI Community Oncology Research Program
      • Dayton, Ohio, Forenede Stater, 45415
        • Dayton Physician LLC - Englewood
      • Delaware, Ohio, Forenede Stater, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, Forenede Stater, 43015
        • Delaware Radiation Oncology
      • Delaware, Ohio, Forenede Stater, 43015
        • Grady Memorial Hospital
      • Fairfield, Ohio, Forenede Stater, 45014
        • Oncology Hematology Care Inc-Healthplex
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Hospital
      • Findlay, Ohio, Forenede Stater, 45840
        • Armes Family Cancer Center
      • Findlay, Ohio, Forenede Stater, 45840
        • Orion Cancer Care
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Franklin, Ohio, Forenede Stater, 45005
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, Forenede Stater, 45331
        • Wayne Hospital
      • Greenville, Ohio, Forenede Stater, 45331
        • Dayton Physicians LLC-Wayne
      • Kettering, Ohio, Forenede Stater, 45429
        • Kettering Medical Center
      • Kettering, Ohio, Forenede Stater, 45409
        • Greater Dayton Cancer Center
      • Kettering, Ohio, Forenede Stater, 45420
        • First Dayton Cancer Care
      • Lancaster, Ohio, Forenede Stater, 43130
        • Fairfield Medical Center
      • Lancaster, Ohio, Forenede Stater, 43130
        • Lancaster Radiation Oncology
      • Marietta, Ohio, Forenede Stater, 45750
        • Marietta Memorial Hospital
      • Middletown, Ohio, Forenede Stater, 45042
        • Dayton Physicians LLC-Signal Point
      • Mount Vernon, Ohio, Forenede Stater, 43050
        • Knox Community Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Newark Radiation Oncology
      • Portsmouth, Ohio, Forenede Stater, 45662
        • Southern Ohio Medical Center
      • Sidney, Ohio, Forenede Stater, 45365
        • Dayton Physicians LLC-Wilson
      • Springfield, Ohio, Forenede Stater, 45504
        • Springfield Regional Cancer Center
      • Springfield, Ohio, Forenede Stater, 45504
        • Springfield Regional Medical Center
      • Steubenville, Ohio, Forenede Stater, 43952
        • Trinity's Tony Teramana Cancer Center
      • Sylvania, Ohio, Forenede Stater, 43560
        • ProMedica Flower Hospital
      • Toledo, Ohio, Forenede Stater, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Troy, Ohio, Forenede Stater, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Forenede Stater, 45373
        • Dayton Physicians LLC - Troy
      • Westerville, Ohio, Forenede Stater, 43081
        • Saint Ann's Hospital
      • Wright-Patterson Air Force Base, Ohio, Forenede Stater, 45433
        • Wright-Patterson Medical Center
      • Xenia, Ohio, Forenede Stater, 45385
        • Greene Memorial Hospital
      • Zanesville, Ohio, Forenede Stater, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Lawton, Oklahoma, Forenede Stater, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Norman, Oklahoma, Forenede Stater, 73071
        • Cancer Care Associates-Norman
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Mercy Hospital Oklahoma City
      • Oklahoma City, Oklahoma, Forenede Stater, 73142
        • Integris Cancer Institute of Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Natalie Warren Bryant Cancer Center at Saint Francis
      • Tulsa, Oklahoma, Forenede Stater, 74146
        • Warren Clinic Oncology-Tulsa
    • Oregon
      • Baker City, Oregon, Forenede Stater, 97814
        • Saint Alphonsus Cancer Care Center-Baker City
      • Grants Pass, Oregon, Forenede Stater, 97527
        • Three Rivers Community Hospital
      • Medford, Oregon, Forenede Stater, 97504
        • Providence Medford Medical Center
      • Medford, Oregon, Forenede Stater, 97504
        • Asante Rogue Regional Medical Center
      • Ontario, Oregon, Forenede Stater, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Forenede Stater, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Pottstown, Pennsylvania, Forenede Stater, 19464
        • Pottstown Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29401
        • Roper Hospital
      • Charleston, South Carolina, Forenede Stater, 29406
        • Lowcountry Hematology Oncology PA-North Charleston
      • Charleston, South Carolina, Forenede Stater, 29414
        • Bon Secours Saint Francis Hospital
      • Charleston, South Carolina, Forenede Stater, 29403
        • Charleston Oncology - Roper
      • Charleston, South Carolina, Forenede Stater, 29414
        • Charleston Oncology - Saint Francis
      • Charleston, South Carolina, Forenede Stater, 29414
        • Lowcountry Oncology Associates - West Ashley
      • Florence, South Carolina, Forenede Stater, 29506
        • McLeod Regional Medical Center
      • Greenville, South Carolina, Forenede Stater, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29601
        • Saint Francis Hospital
      • Mt. Pleasant, South Carolina, Forenede Stater, 29464
        • Lowcountry Oncology Associates - Mount Pleasant
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Rapid City Regional Hospital
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • Wellmont Medical Associates Oncology and Hematology-Bristol
      • Bristol, Tennessee, Forenede Stater, 37620
        • Bristol Regional Medical Center
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Memorial Hospital
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • Erlanger Medical Center
      • Hixson, Tennessee, Forenede Stater, 37343
        • Pulmonary Medicine Center of Chattanooga-Hixson
      • Johnson City, Tennessee, Forenede Stater, 37604
        • Wellmont Medical Associates Oncology and Hematology-Johnson City
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Ballad Health Cancer Care - Kingsport
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Wellmont Holston Valley Hospital and Medical Center
      • Knoxville, Tennessee, Forenede Stater, 37920
        • University of Tennessee - Knoxville
      • Ooltewah, Tennessee, Forenede Stater, 37363
        • Memorial GYN Plus
    • Texas
      • Bryan, Texas, Forenede Stater, 77802
        • Saint Joseph Regional Cancer Center
    • Utah
      • Farmington, Utah, Forenede Stater, 84025
        • Farmington Health Center
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute/University of Utah
      • South Jordan, Utah, Forenede Stater, 84009
        • South Jordan Health Center
    • Virginia
      • Bristol, Virginia, Forenede Stater, 24201
        • Ballad Health Cancer Care - Bristol
      • Mechanicsville, Virginia, Forenede Stater, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, Forenede Stater, 23114
        • Bon Secours Saint Francis Medical Center
      • Norton, Virginia, Forenede Stater, 24273
        • Ballad Health Cancer Care - Norton
      • Richmond, Virginia, Forenede Stater, 23226
        • Bon Secours Saint Mary's Hospital
    • Washington
      • Auburn, Washington, Forenede Stater, 98001
        • MultiCare Auburn Medical Center
      • Bainbridge Island, Washington, Forenede Stater, 98110
        • Virginia Mason Bainbridge Island Medical Center
      • Bellevue, Washington, Forenede Stater, 98004
        • Overlake Medical Center
      • Burien, Washington, Forenede Stater, 98166
        • Highline Medical Center-Main Campus
      • Centralia, Washington, Forenede Stater, 98531
        • Providence Regional Cancer System-Centralia
      • Enumclaw, Washington, Forenede Stater, 98022
        • Saint Elizabeth Hospital
      • Everett, Washington, Forenede Stater, 98201
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, Forenede Stater, 98002
        • Virginia Mason Federal Way Medical Center
      • Federal Way, Washington, Forenede Stater, 98003
        • Saint Francis Hospital
      • Gig Harbor, Washington, Forenede Stater, 98332
        • Tacoma/Valley Radiation Oncology Centers-Gig Harbor
      • Gig Harbor, Washington, Forenede Stater, 98335
        • MultiCare Gig Harbor Medical Park
      • Kennewick, Washington, Forenede Stater, 99336
        • Northwest Cancer Clinic
      • Lacey, Washington, Forenede Stater, 98503
        • Providence Regional Cancer System-Lacey
      • Lakewood, Washington, Forenede Stater, 98499
        • Saint Clare Hospital
      • Lynnwood, Washington, Forenede Stater, 98036
        • Virginia Mason Lynnwood Medical Center
      • Olympia, Washington, Forenede Stater, 98506-5166
        • Providence - Saint Peter Hospital
      • Olympia, Washington, Forenede Stater, 98507
        • Capital Medical Center
      • Port Townsend, Washington, Forenede Stater, 98368
        • Jefferson Healthcare
      • Poulsbo, Washington, Forenede Stater, 98370
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Poulsbo, Washington, Forenede Stater, 98370
        • Peninsula Cancer Center
      • Puyallup, Washington, Forenede Stater, 98372
        • MultiCare Good Samaritan Hospital
      • Puyallup, Washington, Forenede Stater, 98372
        • Tacoma/Valley Radiation Oncology Centers-Puyallup
      • Seattle, Washington, Forenede Stater, 98101
        • Virginia Mason Medical Center
      • Silverdale, Washington, Forenede Stater, 98383
        • Saint Joseph Medical Center Hematology and Oncology - Silverdale
      • Tacoma, Washington, Forenede Stater, 98405
        • Northwest Medical Specialties PLLC
      • Tacoma, Washington, Forenede Stater, 98405
        • MultiCare Tacoma General Hospital
      • Tacoma, Washington, Forenede Stater, 98405
        • Tacoma/Valley Radiation Oncology Centers-Saint Joe's
      • Tacoma, Washington, Forenede Stater, 97405
        • Tacoma/Valley Radiation Oncology Centers-Jackson Hall
      • Tacoma, Washington, Forenede Stater, 98405
        • Franciscan Research Center-Northwest Medical Plaza
      • Tacoma, Washington, Forenede Stater, 98405
        • MultiCare Allenmore Hospital
      • Tacoma, Washington, Forenede Stater, 98405
        • Northwest NCI Community Oncology Research Program
      • Tacoma, Washington, Forenede Stater, 98405
        • Saint Joseph Medical Center
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • West Virginia University Charleston Division
      • Huntington, West Virginia, Forenede Stater, 25701
        • Edwards Comprehensive Cancer Center
      • Princeton, West Virginia, Forenede Stater, 24740
        • Princeton Community Hospital
    • Wisconsin
      • Brookfield, Wisconsin, Forenede Stater, 53045
        • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
      • Burlington, Wisconsin, Forenede Stater, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Chippewa Falls, Wisconsin, Forenede Stater, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • HSHS Sacred Heart Hospital
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Fond du Lac, Wisconsin, Forenede Stater, 54937
        • Aurora Health Center-Fond du Lac
      • Franklin, Wisconsin, Forenede Stater, 53132
        • Ascension Saint Francis - Reiman Cancer Center
      • Germantown, Wisconsin, Forenede Stater, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, Forenede Stater, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, Forenede Stater, 54311
        • Aurora BayCare Medical Center
      • Kenosha, Wisconsin, Forenede Stater, 53142
        • Aurora Cancer Care-Kenosha South
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Center
      • Ladysmith, Wisconsin, Forenede Stater, 54848
        • Marshfield Medical Center - Ladysmith
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center-Marshfield
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center
      • Mequon, Wisconsin, Forenede Stater, 53097
        • Ascension Columbia Saint Mary's Hospital Ozaukee
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, Forenede Stater, 53233
        • Aurora Sinai Medical Center
      • Milwaukee, Wisconsin, Forenede Stater, 53210
        • Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
      • Milwaukee, Wisconsin, Forenede Stater, 53211
        • Ascension Columbia Saint Mary's Hospital - Milwaukee
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Medical Center - Minocqua
      • Mukwonago, Wisconsin, Forenede Stater, 53149
        • ProHealth D N Greenwald Center
      • Oconomowoc, Wisconsin, Forenede Stater, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oshkosh, Wisconsin, Forenede Stater, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, Forenede Stater, 53406
        • Aurora Cancer Care-Racine
      • Rhinelander, Wisconsin, Forenede Stater, 54501
        • Saint Mary's Hospital
      • Rhinelander, Wisconsin, Forenede Stater, 54501
        • Aspirus Cancer Care - James Beck Cancer Center
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Marshfield Medical Center-Rice Lake
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Lakeview Medical Center-Marshfield Clinic
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Stevens Point, Wisconsin, Forenede Stater, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Stevens Point, Wisconsin, Forenede Stater, 54481
        • Aspirus Cancer Care - Stevens Point
      • Summit, Wisconsin, Forenede Stater, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, Forenede Stater, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • ProHealth Waukesha Memorial Hospital
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Aurora Cancer Care-Waukesha
      • Wausau, Wisconsin, Forenede Stater, 54401
        • Marshfield Clinic-Wausau Center
      • Wauwatosa, Wisconsin, Forenede Stater, 53226
        • Aurora Cancer Care-Milwaukee West
      • Wauwatosa, Wisconsin, Forenede Stater, 53226
        • Ascension Medical Group Southeast Wisconsin - Mayfair Road
      • West Allis, Wisconsin, Forenede Stater, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Casper, Wyoming, Forenede Stater, 82609
        • Rocky Mountain Oncology
      • Cody, Wyoming, Forenede Stater, 82414
        • Big Horn Basin Cancer Center
      • Cody, Wyoming, Forenede Stater, 82414
        • Billings Clinic-Cody
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Patienten skal have patologisk bekræftet nyrecellekarcinom med en klar cellekomponent; rene papillære og kromofobe histologier er udelukket; der skal være patologisk bekræftelse af metastatisk sygdom i den resekerede metastasektomiprøve
  • Patienten skal have gennemgået nefrektomi eller delvis nefrektomi for at fjerne primært nyrecellekarcinom (på ethvert tidspunkt tidligere)
  • Patienten skal have gennemgået kirurgisk resektion for at fjerne et eller flere steder med metastatisk sygdom, med vellykket fjernelse af alle kendte steder 2-12 uger før randomisering; et hvilket som helst antal tidligere metastasectomier kan være blevet udført tidligere, så længe den seneste procedure var inden for de 12 uger efter registreringen; den seneste procedure kan være nefrektomi for en nyre primær tumor
  • Patienter med synkron sygdom ved indledende diagnose skal have metastatisk (M1) sygdom (American Joint Committee on Cancer [AJCC] 7. udgave T1-4N0-1M1)
  • Positive kirurgiske marginer er tilladt, hvis kirurgen bekræfter fuldstændig resektion af grov metastatisk sygdom, og postoperative scanninger er negative
  • Patienter med metakron sygdom kan have fjernmetastaser, regional lymfeknude eller nyreseng; tilbagefald på et partiel nefrektomiresektionssted er ikke kvalificerede, hvis det er det eneste sygdomssted

  • Patienten må ikke have tegn på sygdom ved postoperativ billeddannelse:

    • En computertomografi (CT) af brystet skal foretages inden for 4 uger før randomisering med eller uden kontrast
    • En CT af abdomen/bækken skal foretages inden for 4 uger før randomisering med intravenøs (IV) kontrast (oral kontrast kan tilføjes efter radiologens skøn); en magnetisk resonansbilleddannelse (MRI) af abdomen/bækkenet med gadolinium kan erstatte CT, hvis CT med IV kontrast er kontraindiceret
    • En MR af hjernen med og uden gadolinium skal udføres inden for 8 uger før randomisering; en CT af hjernen med og uden IV kontrast er tilladt, hvis MR er kontraindiceret (dvs. pacemaker)
  • Patienten skal have en Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 0 eller 1 på randomiseringstidspunktet
  • Absolut granulocyttal > 1.500/mcL
  • Blodplader > 100.000/mcL
  • Total bilirubin < 1,5 x institutionel øvre normalgrænse (ULN)
  • Aspartat aminotransferase (AST) (serum glutaminsyre oxaloeddikesyre transaminase [SGOT])/alanin aminotransferase (ALT) (serum glutamat pyruvat transaminase [SGPT]) < 2,5 x øvre normalgrænse (ULN)
  • Beregnet kreatininclearance (CrCl) > 30 ml/min
  • Forsøgspersoner skal have et urinprotein/kreatinin (UPC)-forhold < 1; hvis UPC >= 1, så skal der opnås et 24-timers urin totalt protein; forsøgspersoner skal have en 24-timers urinproteinværdi < 1 g for at være berettiget; brug af urinpinde til vurdering af nyrefunktion er ikke acceptabel
  • Alle kvinder i den fødedygtige alder skal have en blodprøve eller urinundersøgelse inden for 2 uger før randomisering for at udelukke graviditet; en kvinde i den fødedygtige alder er enhver kvinde, uanset seksuel orientering, eller om de har gennemgået tubal ligering, som opfylder følgende kriterier: 1) ikke har gennemgået en hysterektomi eller bilateral oophorektomi; eller 2) ikke har været naturligt postmenopausal i mindst 24 på hinanden følgende måneder (dvs. har haft menstruation på noget tidspunkt i de foregående 24 på hinanden følgende måneder)
  • Kvinder i den fødedygtige alder og seksuelt aktive mænd skal kraftigt rådes til at bruge en accepteret og effektiv præventionsmetode eller at afholde sig fra samleje, så længe deres deltagelse i undersøgelsen varer. hvis en kvinde bliver gravid, mens hun deltager i denne undersøgelse, skal hun straks informere sin behandlende læge; hvis en mand imprægnerer en kvinde, mens han deltager i denne undersøgelse, skal han straks informere sin behandlende læge
  • Patienten skal være i stand til at sluge piller og ikke have nogen signifikant svækkelse af gastrointestinal absorption, inklusive historie med gastrisk bypass-operation
  • Patienten skal have et korrigeret QT (QTc) interval på elektrokardiogram (EKG) =< 0,48 sekunder ved Bazetts beregning (=< Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4 grad 2) før randomisering
  • Patienten skal have et systolisk blodtryk =< 140 mmHg, og det diastoliske blodtryk skal være =< 90 mmHg, målt inden for 4 uger før randomisering; påbegyndelse eller justering af antihypertensiva før start af undersøgelsesbehandling er tilladt

Ekskluderingskriterier:

  • Patienter med tumorer i nyrerne (multiple synkrone eller enkelt/multiple metakrone), hvis der ikke er ekstrarenale sygdomssteder (dvs. potentiel multifokal primær sygdom)
  • Forudgående eller samtidig systemisk terapi for RCC; adjuverende placeboadministration er tilladt
  • Aktiv mavesår sygdom
  • Aktiv inflammatorisk tarmsygdom
  • New York Heart Association (NYHA) klasse II eller større kongestiv hjertesvigt
  • Anamnese eller aktuelle klinisk tilsyneladende metastaser i centralnervesystemet
  • Gravid eller ammende
  • Anamnese med allergiske reaktioner tilskrevet forbindelser med lignende kemisk eller biologisk sammensætning som pazopanib
  • Ukontrolleret interkurrent sygdom, herunder, men ikke begrænset til, igangværende eller aktiv infektion, symptomatisk kongestiv hjertesvigt, ustabil angina pectoris, hjertearytmi eller psykiatrisk sygdom/sociale situationer, der ville begrænse overholdelse af undersøgelseskrav
  • Alvorligt eller ikke-helende sår, ulcus eller knoglebrud på randomiseringstidspunktet
  • Anamnese med abdominal fistel, gastrointestinal perforation eller intraabdominal absces inden for 4 uger før randomisering
  • Anamnese med cerebrovaskulær ulykke (CVA) inden for 6 måneder efter randomisering
  • Anamnese med myokardieinfarkt, hospitalsindlæggelse for ustabil angina, hjerteangioplastik eller stenting inden for 6 måneder efter randomisering
  • Anamnese med venøs trombose inden for 12 uger efter randomisering

  • Tager stærke cytokrom P450, familie 3, underfamilie A, polypeptid 4 (CYP3A4) hæmmere såsom:

    • Antibiotika: clarithromycin, telithromycin, troleandomycin
    • Human immundefektvirus (HIV) antivirale proteasehæmmere: ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir
    • Antisvampemidler: itraconazol, ketoconazol, voriconazol, fluconazol
    • Antidepressiva: nefazodon
  • Anamnese med hæmotyse over 2,5 ml (1/2 tsk) inden for 8 uger før randomisering
  • Indtagelse af lægemidler, der vides at forlænge QTc-intervallet; sådanne lægemidler bør seponeres mindst 5 halveringstider før randomisering
  • Anamnese med anden kræftsygdom inden for 3 år fra tidspunktet for randomisering med undtagelse af basalcellehudkræft, pladecellehudkræft, in situ livmoderhalskræft, duktalt eller lobulært karcinom in situ af brystet eller resekeret ikke-invasivt (Ta) urotelcarcinom

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A (Pazopanib)
Patienterne får pazopanibhydrochlorid PO QD på dag 1-28. Behandlingen gentages hver 28. dag i op til 13 kure i fravær af sygdomsprogression eller uacceptabel toksicitet. Patienter gennemgår også CT eller MR under hele undersøgelsen.
Andet: Spørgeskemaadministration
Hjælpestudier
Medicin: Pazopanib Hydrochlorid
Givet PO
Andre navne:
  • GW786034B
  • Votrient
  • Pazopater
  • GW 786034B
  • GW-786034B
Procedure: MR scanning
Gennemgå MR
Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Computertomografi
Gennemgå CT
Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Placebo komparator: Arm B (placebo)
Patienter får placebo PO QD på dag 1-28. Behandlingen gentages hver 28. dag i op til 13 kure i fravær af sygdomsprogression eller uacceptabel toksicitet. Patienter gennemgår også CT eller MR under hele undersøgelsen.
Andet: Spørgeskemaadministration
Hjælpestudier
Procedure: MR scanning
Gennemgå MR
Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Computertomografi
Gennemgå CT
Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Andet: Placebo administration
Givet PO

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sygdomsfri overlevelse (DFS)
Tidsramme: Vurderes hver 3. måned i de første 2 år, hver 6. måned i de næste 3 år og derefter årligt op til 6 år
Sygdomsfri overlevelse (DFS) er defineret som tiden fra randomisering til udvikling af tilbagevendende sygdom, anden primær cancer (bortset fra lokaliseret brystkræft, lokaliseret prostata eller ikke-melanom hudkræft) eller død af enhver årsag.
Vurderes hver 3. måned i de første 2 år, hver 6. måned i de næste 3 år og derefter årligt op til 6 år

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
3-års samlet overlevelsesrate (OS).
Tidsramme: Vurderes hver 3. måned de første 2 år, og derefter hver 6. måned i det 3. år.
Samlet overlevelse er defineret som tiden fra randomisering til død eller dato sidst kendt i live. Kaplan-Meier-metoden blev brugt til at estimere 3-års samlet overlevelsesrate.
Vurderes hver 3. måned de første 2 år, og derefter hver 6. måned i det 3. år.
Kvalitetsjusteret tid uden symptomer på sygdom eller behandling (Q-TWiST)
Tidsramme: Vurderes hver 3. måned i de første 2 år, hver 6. måned i de næste 3 år, derefter årligt op til 10 år

OS for hver arm er opdelt i 3 sundhedstilstande: toksicitet (TOX), tid uden symptomer på sygdom eller toksicitet (TWiST) og recidiv (REC). TOX er defineret som den tid, der bruges med grad 3/4 bivirkninger (AE'er) før sygdomsgentagelse. TWiST er defineret som tiden før sygdomsgentagelse, hvor der ikke blev oplevet nogen AE'er af grad 3/4. REC sundhedstilstand er defineret som tiden fra sygdomsgentagelse eller anden primær cancer til døden. Patienter i live vil blive censureret på datoen for sidste kontakt. For hver sundhedstilstand vil en patientrapporteret nyttevægt blive tildelt. Den gennemsnitlige tid i hver stat vil blive estimeret ved hjælp af Kaplan og Meier-metoden.

TWiST = gennemsnitlig tilbagefaldsfri overlevelse (RFS) - middeltid med toksiciteter REC = middel OS - middel RFS Q-TWiST = (uTOX x TOX) + (uTWiST x TWiST) + (uREC x REC) Hvor uTOX, uTWiST og uREC repræsenterer den gennemsnitlige gruppenytteværdi for hver tilstand for den pågældende arm, og TOX, TWiST og REC repræsenterer middelvarigheden af ​​tilstanden for den pågældende arm.
Vurderes hver 3. måned i de første 2 år, hver 6. måned i de næste 3 år, derefter årligt op til 10 år
Ændring i funktionel vurdering af kronisk sygdomsterapi (FACIT) - træthedsscore fra baseline til 6 måneder
Tidsramme: Vurderet ved baseline og 6 måneder
FACIT-træthedsunderskala (13 punkter) blev brugt til at evaluere træthed i denne patientpopulation. Scoren ligger mellem 0 og 52. Jo højere score, jo bedre livskvalitet. Ændringen i FACIT-træthedsscore fra baseline til 6 måneder vil blive sammenlignet mellem de to arme.
Vurderet ved baseline og 6 måneder
Ændring i funktionel vurdering af kræftterapi-nyresymptomindeksscore fra baseline til 6 måneder
Tidsramme: Vurderet ved baseline og 6 måneder
Funktionel vurdering af kræftterapi Nyrekræft Symptom Index - 15 Item Version (FKSI-15) vil blive brugt til at evaluere bekymringer om livskvalitet blandt denne patientpopulation. Ændringen i score fra baseline til 6 måneder vil blive sammenlignet mellem de to arme. Scoren ligger mellem 0 og 60. En score på "0" er en alvorlig symptomatisk patient, og den højest mulige score er en asymptomatisk patient.
Vurderet ved baseline og 6 måneder
Ændring i plasmaniveauer af Pazopanib fra baseline til cyklus 2 Dag 1
Tidsramme: Vurderet ved baseline og cyklus 2 dag 1
Plasmakoncentrationen af ​​pazopanib vil blive vurderet ved baseline og cyklus 2 dag 1.
Vurderet ved baseline og cyklus 2 dag 1

Andre resultatmål

Resultatmål
Tidsramme
At prospektivt banke konserveret væv fra primære tumorer og associerede metastatiske steder hos patienter med RCC
Tidsramme: Baseline
Baseline

Samarbejdspartnere og efterforskere

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

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Leonard J Appleman, ECOG-ACRIN Cancer Research 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

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)

8. august 2012

Primær færdiggørelse (Faktiske)

17. juli 2018

Studieafslutning (Anslået)

20. februar 2027

Datoer for studieregistrering

Først indsendt

10. april 2012

Først indsendt, der opfyldte QC-kriterier

10. april 2012

Først opslået (Anslået)

11. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2012-00723 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180820 (U.S. NIH-bevilling/kontrakt)
  • U24CA196172 (U.S. NIH-bevilling/kontrakt)
  • U10CA180830 (U.S. NIH-bevilling/kontrakt)
  • U10CA021115 (U.S. NIH-bevilling/kontrakt)
  • E2810 (Anden identifikator: CTEP)
  • CDR0000730383
  • ECOG-E2810

Plan for individuelle deltagerdata (IPD)

IPD-planbeskrivelse

Individuelle deltagerdata kan stilles til rådighed efter anmodning i henhold til ECOG-ACRINs datadelingspolitik.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med Klarcellet nyrecellekarcinom

Kliniske forsøg med Spørgeskemaadministration

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mexico

Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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