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Kombinasjonskjemoterapi ved behandling av pasienter med blærekreft

12. juli 2016 oppdatert av: Alliance for Clinical Trials in Oncology

Fase III-studie som sammenligner sekvensiell kjemoterapi (AG-ITP) med cisplatin og gemcitabin som tilleggsbehandling etter cystektomi for overgangscellekarsinom i blæren

BAKGRUNN: Legemidler som brukes i cellegiftbehandling virker på forskjellige måter for å stoppe tumorceller i å dele seg slik at de slutter å vokse eller dør. Å kombinere mer enn ett medikament kan drepe flere tumorceller.

FORMÅL: Randomisert fase III-studie for å sammenligne ulike kombinasjonskjemoterapiregimer ved behandling av pasienter som har avansert blærekreft.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

MÅL:

Hoved

  • Sammenlign overlevelsen til pasienter med fullstendig resekert lokalt avansert overgangscellekarsinom i blæren behandlet med adjuvant doksorubicin og gemcitabin etterfulgt av paklitaksel og cisplatin vs adjuvant cisplatin og gemcitabin.

Sekundær

  • Sammenlign toksisitetsprofilene til disse regimene hos disse pasientene.

OVERSIKT: Dette er en randomisert studie. Pasientene er stratifisert i henhold til primær tumorstatus (<T4 vs T4), antall positive lymfeknuter (0 eller ukjent vs 1-5 vs >5), og antall dissekerte knuter (0-10 eller ukjent vs > 10). Pasienter er randomisert til en av to behandlingsarmer.

  • Arm I: Pasienter får adjuvant gemcitabin IV over 30 minutter på dag 1, 8 og 15 og cisplatin IV over 30-60 minutter på dag 1. Behandlingen gjentas hver 4. uke i opptil 4 kurer i fravær av sykdomsprogresjon eller uakseptabel toksisitet.
  • Arm II: Pasienter får adjuvant doksorubicin IV over 45 minutter etterfulgt av gemcitabin IV over 2 timer på dag 1. Pasienter får også filgrastim (G-CSF) subkutant (SC) daglig på dag 3-10. Behandlingen gjentas hver 14. dag i opptil 4 kurer i fravær av sykdomsprogresjon eller uakseptabel toksisitet. Fra og med 14 dager etter fullføring av doksorubicin og gemcitabin, får pasienter paklitaksel IV over 3 timer og cisplatin IV over 20-30 minutter på dag 1. Pasienter får også G-CSF SC daglig på dag 3-10 eller 4-11. Behandlingen gjentas hver 14. dag i opptil 4 kurer i fravær av sykdomsprogresjon eller uakseptabel toksisitet.

Pasientene følges hver 3. måned i 18 måneder, hver 6. måned i 18 måneder, og deretter årlig.

Studietype

Intervensjonell

Registrering (Faktiske)

42

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85259
        • CCOP - Mayo Clinic Scottsdale Oncology Program
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Arroyo Grande, California, Forente stater, 93420
        • Arroyo Grande Community Hospital
      • San Diego, California, Forente stater, 92161
        • Veterans Affairs Medical Center - San Diego
      • San Diego, California, Forente stater, 92120
        • Kaiser Permanente Medical Office -Vandever Medical Office
      • San Diego, California, Forente stater, 92103
        • Rebecca and John Moores UCSD Cancer Center
      • San Francisco, California, Forente stater, 94115
        • UCSF Comprehensive Cancer Center
      • San Francisco, California, Forente stater, 94121
        • Veterans Affairs Medical Center - San Francisco
    • Colorado
      • Aurora, Colorado, Forente stater, 80012
        • Aurora Presbyterian Hospital
      • Boulder, Colorado, Forente stater, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, Forente stater, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, Forente stater, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, Forente stater, 80220
        • Rose Medical Center
      • Denver, Colorado, Forente stater, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, Forente stater, 80218
        • St. Joseph Hospital
      • Denver, Colorado, Forente stater, 80224-2522
        • CCOP - Colorado Cancer Research Program, Incorporated
      • Englewood, Colorado, Forente stater, 80110
        • Swedish Medical Center
      • Fort Collins, Colorado, Forente stater, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, Forente stater, 80524
        • Front Range Cancer Specialists
      • Lone Tree, Colorado, Forente stater, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, Forente stater, 80502
        • Hope Cancer Care Center at Longmont United Hospital
      • Pueblo, Colorado, Forente stater, 81004
        • St. Mary-Corwin Regional Medical Center
      • Thorton, Colorado, Forente stater, 80229
        • North Suburban Medical Center
    • Delaware
      • Lewes, Delaware, Forente stater, 19958
        • Beebe Medical Center
      • Newark, Delaware, Forente stater, 19718
        • CCOP - Christiana Care Health Services
      • Wilmington, Delaware, Forente stater, 19805
        • St. Francis Hospital
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20307
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, Forente stater, 20007
        • Lombardi Cancer Center at Georgetown University Medical Center
    • Florida
      • Boca Raton, Florida, Forente stater, 33486
        • Lynn Regional Cancer Center of Boca Raton Community Hospital
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Hollywood, Florida, Forente stater, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jacksonville, Florida, Forente stater, 32224-9980
        • Mayo Clinic - Jacksonville
      • Jupiter, Florida, Forente stater, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Lakeland, Florida, Forente stater, 33805
        • Watson Clinic
      • Miami Beach, Florida, Forente stater, 33140
        • CCOP - Mount Sinai Medical Center
    • Georgia
      • Albany, Georgia, Forente stater, 31703
        • Phoebe Cancer Center at Phoebe Putney Memorial Hospital
      • Altanta, Georgia, Forente stater, 30322
        • Emory University Hospital - Atlanta
      • Athens, Georgia, Forente stater, 30607
        • Hematology and Oncology of Northeast Georgia
      • Augusta, Georgia, Forente stater, 30912
        • MBCCOP-Medical College of Georgia Cancer Center
      • Columbus, Georgia, Forente stater, 31902
        • John B. Amos Community Cancer Center
      • Savannah, Georgia, Forente stater, 31403
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Aurora, Illinois, Forente stater, 60507
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, Forente stater, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, Forente stater, 61520
        • Graham Hospital
      • Carthage, Illinois, Forente stater, 62321
        • Memorial Hospital
      • Chicago, Illinois, Forente stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forente stater, 60640
        • Louis A. Weiss Memorial Hospital
      • Eureka, Illinois, Forente stater, 61530
        • Eureka Hospital
      • Galesburg, Illinois, Forente stater, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, Forente stater, 61401
        • Galesburg Clinic
      • Galesburg, Illinois, Forente stater, 61401
        • InterCommunity Cancer Center of Western Illinois
      • Havana, Illinois, Forente stater, 62644
        • Mason District Hospital
      • Hopedale, Illinois, Forente stater, 61747
        • Hopedale Medical Complex
      • Joliet, Illinois, Forente stater, 60435
        • Joliet Oncology Hematology Associates, Limited - West
      • Kankakee, Illinois, Forente stater, 60901
        • Provena St. Mary's Wasser Regional Cancer Center - Kankakee
      • Kewanee, Illinois, Forente stater, 61443
        • Kewanee Hospital
      • Macomb, Illinois, Forente stater, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, Forente stater, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Normal, Illinois, Forente stater, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Forente stater, 61761
        • Community Cancer Center
      • Ottawa, Illinois, Forente stater, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Forente stater, 61350
        • Oncology Hematology Associates of Central Illinois - Ottawa
      • Pekin, Illinois, Forente stater, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, Forente stater, 61614
        • Proctor Hospital
      • Peoria, Illinois, Forente stater, 61603
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forente stater, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, Forente stater, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Forente stater, 61615
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Peru, Illinois, Forente stater, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, Forente stater, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, Forente stater, 61362
        • St. Margaret's Hospital
      • Spring Valley, Illinois, Forente stater, 61362
        • Valley Cancer Center
      • Springfield, Illinois, Forente stater, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
      • Urbana, Illinois, Forente stater, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, Forente stater, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Beech Grove, Indiana, Forente stater, 46107
        • St. Francis Hospital and Health Centers
      • Elkhart, Indiana, Forente stater, 46515
        • Elkhart General Hospital
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana University Cancer Center
      • Indianapolis, Indiana, Forente stater, 46202
        • William N. Wishard Memorial Hospital
      • La Porte, Indiana, Forente stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Michigan City, Indiana, Forente stater, 46360
        • Saint Anthony Memorial Health Centers
      • Plymouth, Indiana, Forente stater, 46544
        • Saint Joseph Regional Medical Center - Plymouth Campus
      • South Bend, Indiana, Forente stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forente stater, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Ames, Iowa, Forente stater, 50010
        • McFarland Clinic, P.C.
      • Cedar Rapids, Iowa, Forente stater, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Mercy Cancer Center at Mercy Medical Center
      • Davenport, Iowa, Forente stater, 52804
        • Genesis Medical Center - West Campus
      • Davenport, Iowa, Forente stater, 52803
        • Genesis Regional Cancer Center at Genesis Medical Center
      • Des Moines, Iowa, Forente stater, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Forente stater, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Forente stater, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Forente stater, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Forente stater, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forente stater, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Des Moines, Iowa, Forente stater, 50307
        • Mercy Capitol Hospital
      • Dubuque, Iowa, Forente stater, 52001
        • Wendt Regional Cancer Center at Finley Hospital
      • Iowa City, Iowa, Forente stater, 52242
        • Holden Comprehensive Cancer Center at University of Iowa
      • Sioux City, Iowa, Forente stater, 51101-1733
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Forente stater, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, Forente stater, 51104
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, Forente stater, 51101
        • Siouxland Hematology-Oncology Associates
      • West Des Moines, Iowa, Forente stater, 50266
        • Medical Oncology and Hematology Associates - West Des Moines
    • Kansas
      • Chanute, Kansas, Forente stater, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, Forente stater, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, Forente stater, 67042
        • Cancer Center of Kansas, P.A. - El Dorado
      • Kingman, Kansas, Forente stater, 67068
        • Cancer Center of Kansas - Kingman
      • Liberal, Kansas, Forente stater, 67901
        • Southwest Medical Center
      • Newton, Kansas, Forente stater, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, Forente stater, 67357
        • Cancer Center of Kansas, P.A. - Parsons
      • Pratt, Kansas, Forente stater, 67124
        • Pratt Cancer Center of Kansas
      • Salina, Kansas, Forente stater, 67042
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, Forente stater, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, Forente stater, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Forente stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Forente stater, 67203
        • Associates In Womens Health
      • Wichita, Kansas, Forente stater, 67208
        • Cancer Center of Kansas, P.A.
      • Wichita, Kansas, Forente stater, 67214
        • Cancer Center of Kansas, P.A. - Wichita
      • Winfield, Kansas, Forente stater, 67156
        • Cancer Center of Kansas - Winfield
    • Maine
      • Lewiston, Maine, Forente stater, 04240
        • Central Maine Medical Center
      • Scarborough, Maine, Forente stater, 04074
        • Maine Center for Cancer Medicine and Blood Disorders - Scarborough
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287-8936
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Elkton MD, Maryland, Forente stater, 21921
        • Union Hospital Cancer Center at Union Hospital
    • Massachusetts
      • Medford, Massachusetts, Forente stater, 02155
        • Lawrence Memorial Hospital of Medford
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48100
        • CCOP - Michigan Cancer Research Consortium
      • Kalamazoo, Michigan, Forente stater, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Forente stater, 49007
        • Bronson Methodist Hospital
      • Kalamazooaa, Michigan, Forente stater, 49001
        • Borgess Medical Center
      • Royal Oak, Michigan, Forente stater, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Minnesota
      • Burnsville, Minnesota, Forente stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forente stater, 55433
        • Mercy Hospital
      • Edina, Minnesota, Forente stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forente stater, 55432
        • Mercy and Unity Cancer Center at Mercy and Unity Hospitals
      • Hutchinson, Minnesota, Forente stater, 55350
        • Hutchinson Area Health Care
      • Litchfield, Minnesota, Forente stater, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, Forente stater, 55109
        • St. John's Hospital
      • Minneapolis, Minnesota, Forente stater, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, Forente stater, 55415
        • Hennepin County Medical Center - Minneapolis
      • Minneapolis, Minnesota, Forente stater, 55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, Forente stater, 55422
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, Forente stater, 55416
        • CCOP - Metro-Minnesota
      • Saint Paul, Minnesota, Forente stater, 55101
        • Cancer Care Center at Regions Hospital
      • Shakopee, Minnesota, Forente stater, 55379
        • Saint Francis Cancer Center
      • St Paul, Minnesota, Forente stater, 55102
        • St. Joseph's Hospital
      • St. Louis Park, Minnesota, Forente stater, 55416
        • Park Nicollet Clinic
      • St. Paul, Minnesota, Forente stater, 55102
        • United Hospital
      • Waconia, Minnesota, Forente stater, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, Forente stater, 55125
        • Woodwinds Hospital
    • Missouri
      • Columbia, Missouri, Forente stater, 65201
        • Missouri Cancer Associates
      • Kansas City, Missouri, Forente stater, 64131
        • CCOP - Kansas City
      • Springfield, Missouri, Forente stater, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Forente stater, 65807
        • Hulston Cancer Center at Cox Medical Center South
      • St. Louis, Missouri, Forente stater, 63128
        • St. Anthony's Cancer Center
    • Montana
      • Billings, Montana, Forente stater, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Forente stater, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Forente stater, 59101
        • Deaconess Billings Clinic - Downtown
      • Billings, Montana, Forente stater, 59101
        • St. Vincent Healthcare
      • Billings, Montana, Forente stater, 59107
        • Deaconess Billings Clinic Cancer Center
      • Bozeman, Montana, Forente stater, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, Forente stater, 59701
        • St. James Community Hospital
      • Great Falls, Montana, Forente stater, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Forente stater, 59405
        • Sletten Regional Cancer Institute
      • Helena, Montana, Forente stater, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Forente stater, 59901
        • Kalispell Regional Medical Center
      • Miles City, Montana, Forente stater, 59301
        • Eastern Montana Cancer Center
      • Missoula, Montana, Forente stater, 59801
        • Community Medical Center
      • Missoula, Montana, Forente stater, 59802
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
      • Las Vegas, Nevada, Forente stater, 89102
        • University Medical Center of Southern Nevada
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103
        • Cancer Institute of New Jersey at the Cooper University Hospital
      • East Orange, New Jersey, Forente stater, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Hackensack, New Jersey, Forente stater, 07601
        • CCOP - Northern New Jersey
      • Hamilton, New Jersey, Forente stater, 08690
        • Cancer Institute of New Jersey at Hamilton
      • Marlton, New Jersey, Forente stater, 08053
        • Fox Chase Virtua Health Cancer Program - Marlton
      • New Brunswick, New Jersey, Forente stater, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Voorhees, New Jersey, Forente stater, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New York
      • Buffalo, New York, Forente stater, 14263
        • Roswell Park Cancer Institute
      • Glens Falls, New York, Forente stater, 12801
        • Charles R. Wood Cancer Center at Glens Falls Hospital
      • Rochester, New York, Forente stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester, New York, Forente stater, 14621
        • Lipson Cancer and Blood Center at Rochester General Hospital
      • Stony Brook, New York, Forente stater, 11794
        • Long Island Cancer Center at Stony Brook University Hospital
      • Syracuse, New York, Forente stater, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, Forente stater, 13057
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
      • Syracuse, New York, Forente stater, 13215
        • Community General Hospital of Greater Syracuse
    • North Carolina
      • Asheboro, North Carolina, Forente stater, 27203
        • Randolph Hospital
      • Concord, North Carolina, Forente stater, 28025
        • Batte Cancer Center at Northeast Medical Center
      • Durham, North Carolina, Forente stater, 27710
        • Duke Comprehensive Cancer Center
      • Eden, North Carolina, Forente stater, 27288
        • John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
      • Goldsboro, North Carolina, Forente stater, 27534
        • Wayne Memorial Hospital, Incorporated
      • Greensboro, North Carolina, Forente stater, 27401
        • Moses Cone Regional Cancer Center at Wesley Long Community Hospital
      • Kinston, North Carolina, Forente stater, 28501
        • Lenoir Memorial Cancer Center
      • Reidsville, North Carolina, Forente stater, 27320
        • Annie Penn Cancer Center
      • Rutherfordton, North Carolina, Forente stater, 28139
        • Rutherford Hospital
      • Wilson, North Carolina, Forente stater, 27893
        • Wilson Medical Center
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Bismarck, North Dakota, Forente stater, 58501
        • Medcenter One Health System
      • Bismarck, North Dakota, Forente stater, 58501
        • Mid Dakota Clinic, P.C.
      • Bismarck, North Dakota, Forente stater, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, Forente stater, 58501
        • St. Alexius Medical Center
    • Ohio
      • Akron, Ohio, Forente stater, 44304
        • Akron City Hospital at Summa Health System
      • Boardman, Ohio, Forente stater, 44512
        • St. Elizabeth Boardman Cancer Center
      • Chillicothe, Ohio, Forente stater, 54601
        • Adena Regional Medical Center
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forente stater, 44106
        • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
      • Columbus, Ohio, Forente stater, 43215
        • CCOP - Columbus
      • Columbus, Ohio, Forente stater, 43228
        • Doctors Hospital at Ohio Health
      • Columbus, Ohio, Forente stater, 43214
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, Forente stater, 43215
        • Grant Riverside Cancer Services
      • Columbus, Ohio, Forente stater, 43222
        • Mount Carmel West Hospital
      • Columbus, Ohio, Forente stater, 43210
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
      • Dayton, Ohio, Forente stater, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, Forente stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forente stater, 45405
        • Grandview Hospital
      • Dayton, Ohio, Forente stater, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Forente stater, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Forente stater, 45429
        • CCOP - Dayton
      • Delaware, Ohio, Forente stater, 43015
        • Grady Memorial Hospital
      • Independence, Ohio, Forente stater, 44131
        • Community Oncology Group - Independence
      • Kettering, Ohio, Forente stater, 45429
        • Charles F. Kettering Memorial Hospital
      • Lancaster, Ohio, Forente stater, 43130
        • Fairfield Medical Center
      • Marietta, Ohio, Forente stater, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Middletown, Ohio, Forente stater, 45044
        • Middletown Regional Hospital
      • Newark, Ohio, Forente stater, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Springfield, Ohio, Forente stater, 45505
        • Community Hospital of Springfield and Clark County
      • Springfield, Ohio, Forente stater, 45504
        • Mercy Medical Center Oncology Unit
      • Troy, Ohio, Forente stater, 45373
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Warren, Ohio, Forente stater, 44484
        • St. Joseph Health Care Center
      • Westerville, Ohio, Forente stater, 43081
        • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
      • Wooster, Ohio, Forente stater, 44691
        • Cleveland Clinic - Wooster
      • Xenia, Ohio, Forente stater, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
      • Youngstown, Ohio, Forente stater, 44510
        • St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
      • Zanesville, Ohio, Forente stater, 43701
        • Genesis - Good Samaritan Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Oklahoma University Medical Center
    • Oregon
      • Glesham, Oregon, Forente stater, 97030
        • Legacy Mount Hood Medical Center
      • Klamath Falls, Oregon, Forente stater, 97601
        • Cancer Treatment Center at Merle West Medical Center
      • Milwaukie, Oregon, Forente stater, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, Forente stater, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Forente stater, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, Forente stater, 97210
        • Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
      • Portland, Oregon, Forente stater, 97213
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, Forente stater, 97227
        • Institute of Oncology at Vilnius University
      • Tualatin, Oregon, Forente stater, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Danville, Pennsylvania, Forente stater, 17822-2001
        • Geisinger Medical Center
      • Hershey, Pennsylvania, Forente stater, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Lemoyne, Pennsylvania, Forente stater, 17043
        • Central Pennsylvania Hematology and Medical Oncology Associates, PC
      • Lewistown, Pennsylvania, Forente stater, 17044
        • Lewistown Hospital
      • Media, Pennsylvania, Forente stater, 19063
        • Riddle Memorial Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Joan Karnell Cancer Center at Pennsylvania Hospital
      • Pittsburg, Pennsylvania, Forente stater, 15213
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute
      • Pottstown, Pennsylvania, Forente stater, 19464
        • Pottstown Memorial Regional Cancer Center
      • State College, Pennsylvania, Forente stater, 16801
        • Geisinger Medical Group
      • State College, Pennsylvania, Forente stater, 16803
        • Mount Nittany Medical Center
      • Wilkes-Barre, Pennsylvania, Forente stater, 18711
        • Geisinger Wyoming Valley Medical Center
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, Forente stater, 02906
        • Miriam Hospital at Lifespan
    • South Carolina
      • Anderson, South Carolina, Forente stater, 29621
        • Rose Ramer Cancer Clinic at Anderson Area Medical Center
      • Charleston, South Carolina, Forente stater, 29401
        • Roper St. Francis Healthcare - Roper Hospital
      • Greenville, South Carolina, Forente stater, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, Forente stater, 29601
        • Bon Secours St. Francis Health System
      • Greenville, South Carolina, Forente stater, 29605
        • Greenville Hospital System Cancer Center
      • Spartanburg, South Carolina, Forente stater, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
      • Spartanburg, South Carolina, Forente stater, 29304
        • CCOP - Upstate Carolina
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, Forente stater, 57104
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, Forente stater, 57105
        • Avera McKennan Hospital and University Health Center
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Virginia
      • Danville, Virginia, Forente stater, 24541
        • Danville Regional Medical Center
    • Washington
      • Spokane, Washington, Forente stater, 99204
        • Providence Cancer Center at Sacred Heart Medical Center
      • Spokane, Washington, Forente stater, 99207
        • Providence Cancer Center at Holy Family Hospital
      • Vancouver, Washington, Forente stater, 98668
        • Cancer Center at Southwest Washington Medical Center
    • West Virginia
      • Charleston, West Virginia, Forente stater, 25304
        • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
      • Huntington, West Virginia, Forente stater, 25702
        • St. Mary's Medical Center
      • Morgantown, West Virginia, Forente stater, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Appleton, Wisconsin, Forente stater, 54911-3496
        • Fox Valley Hematology and Oncology
      • La Crosse, Wisconsin, Forente stater, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin Comprehensive Cancer Center
      • Madison, Wisconsin, Forente stater, 53715
        • UW Health Oncology
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin Cancer Center
      • Wausau, Wisconsin, Forente stater, 54401
        • University of Wisconsin Cancer Center at Aspirus Wausau Hospital
    • Wyoming
      • Sheridan, Wyoming, Forente stater, 82801
        • Welch Cancer Center

Deltakelseskriterier

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

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

SYKDOMENS KARAKTERISTIKA:

  • Histologisk bekreftet overgangscellekarsinom i blæren

    • Enhver T, N+, M0 ELLER
    • T3a-4a, N0, M0

  • Minst 6 uker, men ikke mer enn 3 måneder siden tidligere fullstendig reseksjon av blæren

    • Cystoprostatektomi pluss bekkenlymfeknutedisseksjon hos menn
    • Cystektomi/total abdominal hysterektomi/bilateral salpingo-ooforektomi pluss bekkenlymfeknutedisseksjon hos kvinner
    • Negative kirurgiske marginer
  • Karsinom in situ tillatt
  • Ingen partiell cystektomi eller transuretral blæretumorreseksjon som definitiv lokoregional terapi
  • Prostatakreft oppdaget i resekert prøve tillatt hvis postoperativ PSA ikke er mer enn 0,05 mg/dL
  • Ingen metastatisk eller tilbakevendende sykdom ved postoperativ røntgen av thorax og CT-skanning av mage og bekken

PASIENT EGENSKAPER:

Alder:

  • 18 og over

Ytelsesstatus:

  • ECOG 0-1

Hematopoetisk:

  • Absolutt nøytrofiltall ≥ 1500/mm^3
  • Blodplateantall ≥ 150 000/mm^3

Hepatisk:

  • Bilirubin ≤ 1,5 ganger øvre normalgrense (ULN)
  • Alkalisk fosfatase ≤ 2 ganger ULN
  • AST ≤ 2 ganger ULN

Nyre:

  • Kreatinin ≤ 1,5 mg/dL ELLER
  • Kreatininclearance ≥ 60 ml/min

Kardiovaskulær:

  • Normal hjertefunksjon ved anamnese, fysisk undersøkelse eller røntgen av thorax
  • Venstre ventrikkel ejeksjonsfraksjon minst 50 % ved radionuklidventrikulogram eller ekkokardiogram, for tidligere hjertesykdom
  • Ingen New York Heart Association klasse III eller IV hjertesykdom
  • Ingen alvorlige hjertearytmier inkludert første-, andre- og tredjegrads hjerteblokk

Annen:

  • Negativ graviditetstest
  • Ingen ukontrollert infeksjon
  • Ingen annen aktiv kreft i løpet av de siste 5 årene bortsett fra ikke-melanom hudkreft eller kurativt behandlet karsinom in situ i livmorhalsen

FØR SAMTIDIG TERAPI:

Biologisk terapi:

  • Ikke spesifisert

Kjemoterapi:

  • Ingen tidligere systemisk kjemoterapi

Endokrin terapi:

  • Ikke spesifisert

Strålebehandling:

  • Ingen tidligere strålebehandling av blæren

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Gemcitabin + cisplatin
Legemiddel: cisplatin
60 mg/m² IV
Legemiddel: gemcitabinhydroklorid
1000 mg/m² IV for Gem + cis-arm og 2000 mg/sqm IV for gem + dox + pinnearm
Aktiv komparator: Gemcitabin + Doxorubicin + Pegfilgrastim
Legemiddel: gemcitabinhydroklorid
1000 mg/m² IV for Gem + cis-arm og 2000 mg/sqm IV for gem + dox + pinnearm
Biologisk: filgrastim
6 mg sub Q
Legemiddel: doksorubicinhydroklorid
50 mg/m² IV

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse
Tidsramme: 4 år
4 år

Samarbeidspartnere og etterforskere

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Dean Bajorin, MD, Memorial Sloan Kettering Cancer Center

Studierekorddatoer

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

Studer hoveddatoer

Studiestart

1. mars 2004

Primær fullføring (Faktiske)

1. juli 2005

Studiet fullført (Faktiske)

1. april 2009

Datoer for studieregistrering

Først innsendt

10. april 2001

Først innsendt som oppfylte QC-kriteriene

9. juni 2003

Først lagt ut (Anslag)

10. juni 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CALGB-90104
  • P30CA008748 (U.S. NIH-stipend/kontrakt)
  • MSKCC-00138
  • NCI-G01-1935
  • CDR0000068554 (Registeridentifikator: NCI Physician Data Query)

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

Kliniske studier på cisplatin

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Luxembourg

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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