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Kombination af kemoterapi til behandling af patienter med blærekræft

12. juli 2016 opdateret af: Alliance for Clinical Trials in Oncology

Fase III-studie, der sammenligner sekventiel kemoterapi (AG-ITP) med cisplatin og gemcitabin som adjuverende behandling efter cystektomi for overgangscellekarcinom i blæren

RATIONALE: Lægemidler, der bruges i kemoterapi, virker på forskellige måder for at stoppe tumorceller i at dele sig, så de holder op med at vokse eller dør. Kombination af mere end et lægemiddel kan dræbe flere tumorceller.

FORMÅL: Randomiseret fase III-forsøg til at sammenligne forskellige kombinationskemoterapiregimer til behandling af patienter, der har fremskreden blærekræft.

Studieoversigt

Status

Afsluttet

Betingelser

Blærekræft

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

Primær

Sammenlign overlevelsen af patienter med fuldstændig resekeret lokalt fremskreden overgangscellecarcinom i blæren behandlet med adjuverende doxorubicin og gemcitabin efterfulgt af paclitaxel og cisplatin vs adjuverende cisplatin og gemcitabin.

Sekundær

Sammenlign toksicitetsprofilerne for disse regimer hos disse patienter.

OVERSIGT: Dette er en randomiseret undersøgelse. Patienterne stratificeres efter primær tumorstatus (<T4 vs. T4), antal positive lymfeknuder (0 eller ukendt vs. 1-5 vs. >5) og antal dissekerede knuder (0-10 eller ukendt vs. > 10). Patienterne randomiseres til en af to behandlingsarme.

Arm I: Patienterne får adjuverende gemcitabin IV over 30 minutter på dag 1, 8 og 15 og cisplatin IV over 30-60 minutter på dag 1. Behandlingen gentages hver 4. uge i op til 4 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.
Arm II: Patienterne får adjuverende doxorubicin IV over 45 minutter efterfulgt af gemcitabin IV over 2 timer på dag 1. Patienterne får også filgrastim (G-CSF) subkutant (SC) dagligt på dag 3-10. Behandlingen gentages hver 14. dag i op til 4 kure i fravær af sygdomsprogression eller uacceptabel toksicitet. Begyndende 14 dage efter afslutningen af doxorubicin og gemcitabin får patienterne paclitaxel IV over 3 timer og cisplatin IV over 20-30 minutter på dag 1. Patienter får også G-CSF SC dagligt på dag 3-10 eller 4-11. Behandlingen gentages hver 14. dag i op til 4 kure i fravær af sygdomsprogression eller uacceptabel toksicitet.

Patienterne følges hver 3. måned i 18 måneder, hver 6. måned i 18 måneder og derefter årligt.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 3

Kontakter og lokationer

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

Studiesteder

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

Køn, der er berettiget til at studere

Alle

Beskrivelse

SYGDOMS KARAKTERISTIKA:

Histologisk bekræftet overgangscellekarcinom i blæren
- Enhver T, N+, M0 ELLER
- T3a-4a, NO, M0
Mindst 6 uger, men ikke mere end 3 måneder siden forudgående fuldstændig resektion af blæren
- Cystoprostatektomi plus bækkenlymfeknudedissektion hos mænd
- Cystektomi/total abdominal hysterektomi/bilateral salpingo-ooforektomi plus bækkenlymfeknudedissektion hos kvinder
- Negative kirurgiske marginer
Karcinom in situ tilladt
Ingen partiel cystektomi eller transurethral blæretumorresektion som definitiv lokoregional terapi
Prostatacancer påvist i resekeret prøve tilladt, hvis postoperativ PSA ikke er mere end 0,05 mg/dL
Ingen metastatisk eller tilbagevendende sygdom ved postoperativ røntgen af thorax og CT-scanning af mave og bækken

PATIENT KARAKTERISTIKA:

Alder:

18 og derover

Ydeevnestatus:

ØKOG 0-1

Hæmatopoietisk:

Absolut neutrofiltal ≥ 1.500/mm^3
Blodpladeantal ≥ 150.000/mm^3

Hepatisk:

Bilirubin ≤ 1,5 gange øvre normalgrænse (ULN)
Alkalisk fosfatase ≤ 2 gange ULN
AST ≤ 2 gange ULN

Nyre:

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

Kardiovaskulær:

Normal hjertefunktion ved historie, fysisk undersøgelse eller røntgenbillede af thorax
Venstre ventrikel ejektionsfraktion mindst 50 % ved radionuklidventrikulogram eller ekkokardiogram, for tidligere hjertesygdom
Ingen New York Heart Association klasse III eller IV hjertesygdom
Ingen alvorlige hjertearytmier inklusive første-, anden- og tredjegrads hjerteblokade

Andet:

Negativ graviditetstest
Ingen ukontrolleret infektion
Ingen anden aktiv cancer inden for de seneste 5 år undtagen ikke-melanom hudkræft eller helbredende behandlet carcinom in situ af livmoderhalsen

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi:

Ikke specificeret

Kemoterapi:

Ingen forudgående systemisk kemoterapi

Endokrin terapi:

Ikke specificeret

Strålebehandling:

Ingen forudgående strålebehandling af blæren

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: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Aktiv komparator: Gemcitabin + cisplatin	Medicin: cisplatin 60 mg/m² IV Medicin: gemcitabin hydrochlorid 1000 mg/sqm IV for Gem + cis-arm og 2000 mg/sqm IV for gem + dox + pindearm
Aktiv komparator: Gemcitabin + Doxorubicin + Pegfilgrastim	Medicin: gemcitabin hydrochlorid 1000 mg/sqm IV for Gem + cis-arm og 2000 mg/sqm IV for gem + dox + pindearm Biologisk: filgrastim 6 mg sub Q Medicin: doxorubicin hydrochlorid 50 mg/m² IV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Samlet overlevelse Tidsramme: 4 år	4 år

Samarbejdspartnere og efterforskere

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

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

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

1. marts 2004

Primær færdiggørelse (Faktiske)

1. juli 2005

Studieafslutning (Faktiske)

1. april 2009

Datoer for studieregistrering

Først indsendt

10. april 2001

Først indsendt, der opfyldte QC-kriterier

9. juni 2003

Først opslået (Skøn)

10. juni 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

CALGB-90104
P30CA008748 (U.S. NIH-bevilling/kontrakt)
MSKCC-00138
NCI-G01-1935
CDR0000068554 (Registry Identifier: NCI Physician Data Query)

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 cisplatin

West China Second University Hospital

Rekruttering

Paclitaxel i.v. Plus Cisplatin i.p til NACT hos patienter med avanceret ovariecancer

Neoadjuverende kemoterapi | Epitelkarcinom, ovarie

Kina
Cedars-Sinai Medical Center

Rekruttering

Forsøg med de-intensiveret postoperativ kemoradiation efter robotkirurgi for HPV-positiv orofaryngeal cancer

HPV-positivt orofaryngealt planocellulært karcinom

Forenede Stater
Privo Technologies
National Cancer Institute (NCI)

Afsluttet

Sikkerheds- og effektivitetsundersøgelse af PRV111 hos forsøgspersoner med oral planocellulær karcinom (PRV111)

Oralt planocellulært karcinom

Forenede Stater
Insmed Incorporated

Afsluttet

Inhalation SLIT Cisplatin (Liposomal) til behandling af osteosarkom metastaserende til lungen

Osteosarkom Metastatisk

Forenede Stater
Lawson Health Research Institute

Rekruttering

Lavdosis ugentlig vs højdosis cisplatin (RADIO)

Lokalt avanceret hoved- og halspladecellekarcinom

Canada
Sun Yat-sen University

Aktiv, ikke rekrutterende

Fase II forsøg med neoadjuverende og adjuverende anti-PD-1 antistof Toripalimab kombineret med CCRT hos NPC-patienter

Nasopharyngealt karcinom

Kina
Taiho Oncology, Inc.
Quintiles, Inc.

Afsluttet

En undersøgelse af sikkerhed og effektivitet hos patienter med mavekræft

Mavekræft

Forenede Stater, Canada
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial... og andre samarbejdspartnere

Aktiv, ikke rekrutterende

GP vs PF som induktionskemoterapi kombineret med CCRT for lokoregionalt avanceret nasopharyngealt karcinom

Nasopharyngealt karcinom | Nasopharyngeale neoplasmer | Nasopharyngeale sygdomme | Neoplasma i hoved og hals

Kina
Fujian Cancer Hospital

Ikke rekrutterer endnu

Induktionskemoterapi og immunterapi kombineret strålebehandling med eller uden samtidig kemoterapi til trin III-IVa NPC

Nasopharyngealt karcinom

Kina
Bangabandhu Sheikh Mujib Medical University, Dhaka...

Afsluttet

En eksperimentel undersøgelse til at sammenligne behandlingsrespons og toksiciteter ved samtidig kemoradiation med ugentlig cisplatin og 3 ugentlige cisplatin ved lokalt avanceret hoved- og halskræft. (HNC)

Planocellulært karcinom i hoved og hals

Bangladesh

Kombination af kemoterapi til behandling af patienter med blærekræft

Fase III-studie, der sammenligner sekventiel kemoterapi (AG-ITP) med cisplatin og gemcitabin som adjuverende behandling efter cystektomi for overgangscellekarcinom i blæren

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med cisplatin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Luxembourg

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer