- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03609216
Gemcitabin og cisplatin uden cystektomi til patienter med muskelinvasiv blæreurothelial kræft og udvalgte genetiske ændringer
Et fase II-studie af gemcitabin plus cisplatin kemoterapi hos patienter med muskelinvasiv blærekræft med blærekonservering for de patienter, hvis tumorer har skadelig DNA-skaderespons (DDR) genændringer
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
PRIMÆRE MÅL:
I. For at bestemme 3-års hændelsesfri overlevelse, defineret som andelen af patienter uden invasiv eller metastatisk recidiv efter definitiv gemcitabinhydrochlorid (gemcitabin) og cisplatin (standard eller dosistæt) kemoterapi hos de patienter, hvis transurethrale resektion af præ-behandling blæretumor (TURBT)-tumorer rummer skadelige DDR-genændringer, og som opnår < cT1-respons på kemoterapi.
SEKUNDÆRE MÅL:
I. At bestemme den kliniske responsrate (< cT1) for patienter med skadelige DDR-genændringer efter dosistæt gemcitabin og cisplatin.
II. At bestemme blære-intakt og overordnet overlevelse for DDR-ændrede patienter med < cT1.
III. For DDR-gen ændrede patienter, der vælger radikal cystektomi på trods af < cT1, for at bestemme pT0-raten i denne patientpopulation.
IV. At bestemme den patologiske responsrate ved cystektomi og 3-års tilbagefaldsfri og samlet overlevelse for patienter uden DDR-mutationer, som er registreret i dette forsøg.
V. At vurdere den lokale behandlingsbyrde (Bacillus Calmette-Guerin [BCG] terapi, resektion af ikke-invasiv sygdom, checkpoint blokade) over tid i den blærebesparende gruppe.
VI. At bestemme den blære-intakte sygdomsfri overlevelse hos patienter, der vælger at gennemgå kemoradiationsterapi i DDR-mutantgruppen og DDR-vildtypegruppen.
OMRIDS:
Deltagerne får gemcitabinhydrochlorid intravenøst (IV) over 30 minutter på dag 1, cisplatin IV på dag 1 og 2 og pegfilgrastim subkutant (SC) på dag 3. Behandlingen gentages hver 14. dag i op til 6 kure i fravær af sygdomsprogression eller uaccepteret toksicitet. Deltagerne tildeles derefter 1 af 2 arme.
ARM I: Deltagere med DDR-genændring og sygdomsstadium < cT1 gennemgår blærebesparelse.
ARM II: Deltagere med DDR-genændring og sygdomsstadium >= cT1 eller deltagere uden DDR-genændring gennemgår radikal cystektomi eller kemoradioterapi.
Efter afsluttet studiebehandling følges deltagerne op i 5 år.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Alaska
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Fairbanks, Alaska, Forenede Stater, 99701
- Fairbanks Memorial Hospital
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Arizona
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Goodyear, Arizona, Forenede Stater, 85338
- CTCA at Western Regional Medical Center
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Phoenix, Arizona, Forenede Stater, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Fort Smith, Arkansas, Forenede Stater, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, Forenede Stater, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
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California
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Arroyo Grande, California, Forenede Stater, 93420
- Mission Hope Medical Oncology - Arroyo Grande
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Carmichael, California, Forenede Stater, 95608
- Mercy San Juan Medical Center
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Carmichael, California, Forenede Stater, 95608
- Mercy Cancer Center - Carmichael
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Elk Grove, California, Forenede Stater, 95758
- Mercy Cancer Center - Elk Grove
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Los Angeles, California, Forenede Stater, 90048
- Cedars Sinai Medical Center
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Martinez, California, Forenede Stater, 94553-3156
- Contra Costa Regional Medical Center
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Marysville, California, Forenede Stater, 95901
- Fremont - Rideout Cancer Center
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Merced, California, Forenede Stater, 95340
- Mercy Cancer Center
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Rocklin, California, Forenede Stater, 95765
- Mercy Cancer Center - Rocklin
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Comprehensive Cancer Center
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Sacramento, California, Forenede Stater, 95816
- Mercy Cancer Center - Sacramento
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San Luis Obispo, California, Forenede Stater, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, Forenede Stater, 93444
- Mission Hope Medical Oncology - Santa Maria
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Stockton, California, Forenede Stater, 95204
- Saint Joseph's Medical Center
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Walnut Creek, California, Forenede Stater, 94598
- BASS Medical Group - Lennon
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Woodland, California, Forenede Stater, 95695
- Woodland Memorial Hospital
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, Forenede Stater, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Forenede Stater, 80304
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, Forenede Stater, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Forenede Stater, 80907
- Rocky Mountain Cancer Centers-Penrose
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Colorado Springs, Colorado, Forenede Stater, 80923
- Saint Francis Cancer Center
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Forenede Stater, 80210
- AdventHealth Porter
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Durango, Colorado, Forenede Stater, 81301
- Mercy Medical Center
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Durango, Colorado, Forenede Stater, 81301
- CommonSpirit Cancer Center Mercy
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Englewood, Colorado, Forenede Stater, 80113
- Mountain Blue Cancer Care Center - Swedish
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Englewood, Colorado, Forenede Stater, 80113
- Swedish Medical Center
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Englewood, Colorado, Forenede Stater, 80113
- The Melanoma and Skin Cancer Institute
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Golden, Colorado, Forenede Stater, 80401
- Mountain Blue Cancer Care Center
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Greeley, Colorado, Forenede Stater, 80631
- Banner North Colorado Medical Center
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Lakewood, Colorado, Forenede Stater, 80228
- Saint Anthony Hospital
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Lakewood, Colorado, Forenede Stater, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Littleton, Colorado, Forenede Stater, 80120
- Rocky Mountain Cancer Centers-Littleton
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Littleton, Colorado, Forenede Stater, 80122
- AdventHealth Littleton
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Lone Tree, Colorado, Forenede Stater, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Forenede Stater, 80501
- Longmont United Hospital
-
Longmont, Colorado, Forenede Stater, 80501
- Rocky Mountain Cancer Centers-Longmont
-
Loveland, Colorado, Forenede Stater, 80539
- Banner North Colorado Medical Center - Loveland Campus
-
Parker, Colorado, Forenede Stater, 80138
- Rocky Mountain Cancer Centers-Parker
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Parker, Colorado, Forenede Stater, 80138
- AdventHealth Parker
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Pueblo, Colorado, Forenede Stater, 81004
- Saint Mary Corwin Medical Center
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Pueblo, Colorado, Forenede Stater, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Thornton, Colorado, Forenede Stater, 80260
- Rocky Mountain Cancer Centers-Thornton
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Westminster, Colorado, Forenede Stater, 80023
- Saint Anthony North Hospital
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06102
- Hartford Hospital
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Meriden, Connecticut, Forenede Stater, 06451
- Midstate Medical Center
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New Britain, Connecticut, Forenede Stater, 06050
- The Hospital of Central Connecticut
-
Norwich, Connecticut, Forenede Stater, 06360
- William Backus Hospital
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Holy Cross Hospital
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Gainesville, Florida, Forenede Stater, 32610
- UF Health Cancer Institute - Gainesville
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Idaho
-
Boise, Idaho, Forenede Stater, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Caldwell, Idaho, Forenede Stater, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Forenede Stater, 83814
- Kootenai Health - Coeur d'Alene
-
Emmett, Idaho, Forenede Stater, 83617
- Walter Knox Memorial Hospital
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Meridian, Idaho, Forenede Stater, 83642
- Idaho Urologic Institute-Meridian
-
Nampa, Idaho, Forenede Stater, 83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Post Falls, Idaho, Forenede Stater, 83854
- Kootenai Clinic Cancer Services - Post Falls
-
Sandpoint, Idaho, Forenede Stater, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Illinois
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Alton, Illinois, Forenede Stater, 62002
- OSF Saint Anthony's Health Center
-
Aurora, Illinois, Forenede Stater, 60504
- Rush-Copley Medical Center
-
Bloomington, Illinois, Forenede Stater, 61704
- Illinois CancerCare-Bloomington
-
Canton, Illinois, Forenede Stater, 61520
- Illinois CancerCare-Canton
-
Carbondale, Illinois, Forenede Stater, 62902
- Memorial Hospital of Carbondale
-
Carterville, Illinois, Forenede Stater, 62918
- SIH Cancer Institute
-
Carthage, Illinois, Forenede Stater, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, Forenede Stater, 62801
- Centralia Oncology Clinic
-
Centralia, Illinois, Forenede Stater, 62801
- Saint Mary's Hospital
-
Chicago, Illinois, Forenede Stater, 60612
- University of Illinois
-
Danville, Illinois, Forenede Stater, 61832
- Carle at The Riverfront
-
Decatur, Illinois, Forenede Stater, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Forenede Stater, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon, Illinois, Forenede Stater, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Forenede Stater, 62401
- Crossroads Cancer Center
-
Effingham, Illinois, Forenede Stater, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Forenede Stater, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Forenede Stater, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare-Galesburg
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Harvey, Illinois, Forenede Stater, 60426
- Ingalls Memorial Hospital
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Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Forenede Stater, 61938
- Carle Physician Group-Mattoon/Charleston
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Mount Vernon, Illinois, Forenede Stater, 62864
- SSM Health Good Samaritan
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O'Fallon, Illinois, Forenede Stater, 62269
- Cancer Care Center of O'Fallon
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O'Fallon, Illinois, Forenede Stater, 62269
- HSHS Saint Elizabeth's Hospital
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Ottawa, Illinois, Forenede Stater, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Forenede Stater, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Forenede Stater, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forenede Stater, 61637
- 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
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Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Forenede Stater, 61354
- Valley Radiation Oncology
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Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare-Princeton
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Rockford, Illinois, Forenede Stater, 61114
- UW Health Carbone Cancer Center Rockford
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Springfield, Illinois, Forenede Stater, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic
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Springfield, Illinois, Forenede Stater, 62781
- Springfield Memorial Hospital
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Swansea, Illinois, Forenede Stater, 62226
- Southwest Illinois Health Services LLP
-
Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center
-
Urbana, Illinois, Forenede Stater, 61801
- The Carle Foundation Hospital
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Washington, Illinois, Forenede Stater, 61571
- Illinois CancerCare - Washington
-
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Indiana
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Richmond, Indiana, Forenede Stater, 47374
- Reid Health
-
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Iowa
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Carroll, Iowa, Forenede Stater, 51401
- Saint Anthony Regional Hospital
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Clive, Iowa, Forenede Stater, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Forenede Stater, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Council Bluffs, Iowa, Forenede Stater, 51503
- Alegent Health Mercy Hospital
-
Creston, Iowa, Forenede Stater, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, Forenede Stater, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Forenede Stater, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Forenede Stater, 50314
- Broadlawns Medical Center
-
Des Moines, Iowa, Forenede Stater, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Forenede Stater, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines, Iowa, Forenede Stater, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Fort Dodge, Iowa, Forenede Stater, 50501
- UI Healthcare Mission Cancer and Blood - Fort Dodge
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West Des Moines, Iowa, Forenede Stater, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Forenede Stater, 50266
- Mercy Medical Center-West Lakes
-
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Kansas
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Garden City, Kansas, Forenede Stater, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Forenede Stater, 67530
- Central Care Cancer Center - Great Bend
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Cancer Center
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Pittsburg, Kansas, Forenede Stater, 66762
- Mercy Hospital Pittsburg
-
Westwood, Kansas, Forenede Stater, 66205
- University of Kansas Hospital-Westwood Cancer Center
-
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Kentucky
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Bardstown, Kentucky, Forenede Stater, 40004
- Flaget Memorial Hospital
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Corbin, Kentucky, Forenede Stater, 40701
- Commonwealth Cancer Center-Corbin
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Lexington, Kentucky, Forenede Stater, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, Forenede Stater, 40509
- Saint Joseph Hospital East
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Lexington, Kentucky, Forenede Stater, 40504
- Saint Joseph Hospital
-
London, Kentucky, Forenede Stater, 40741
- Saint Joseph London
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Louisville, Kentucky, Forenede Stater, 40202
- Jewish Hospital
-
Louisville, Kentucky, Forenede Stater, 40245
- UofL Health Medical Center Northeast
-
Louisville, Kentucky, Forenede Stater, 40215
- Saints Mary and Elizabeth Hospital
-
Shepherdsville, Kentucky, Forenede Stater, 40165
- Jewish Hospital Medical Center South
-
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70805
- LSU Health Baton Rouge-North Clinic
-
Baton Rouge, Louisiana, Forenede Stater, 70809
- Louisiana Hematology Oncology Associates LLC
-
Baton Rouge, Louisiana, Forenede Stater, 70809
- Mary Bird Perkins Cancer Center
-
Baton Rouge, Louisiana, Forenede Stater, 70808
- Our Lady of The Lake
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Baton Rouge, Louisiana, Forenede Stater, 70808
- Our Lady of the Lake Physician Group
-
Covington, Louisiana, Forenede Stater, 70433
- Northshore Oncology Associates-Covington
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Houma, Louisiana, Forenede Stater, 70360
- Terrebonne General Medical Center
-
Metairie, Louisiana, Forenede Stater, 70006
- East Jefferson General Hospital
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Metairie, Louisiana, Forenede Stater, 70006
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
-
Metairie, Louisiana, Forenede Stater, 70002
- Mary Bird Perkins Cancer Center - Metairie
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Medical Center Jefferson
-
New Orleans, Louisiana, Forenede Stater, 70112
- University Medical Center New Orleans
-
New Orleans, Louisiana, Forenede Stater, 70112
- Louisiana State University Health Science Center
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland/Greenebaum Cancer Center
-
Baltimore, Maryland, Forenede Stater, 21201
- Maryland Proton Treatment Center
-
Columbia, Maryland, Forenede Stater, 21044
- Central Maryland Radiation Oncology in Howard County
-
Glen Burnie, Maryland, Forenede Stater, 21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
-
-
Massachusetts
-
Springfield, Massachusetts, Forenede Stater, 01104
- Mercy Medical Center
-
-
Michigan
-
Alma, Michigan, Forenede Stater, 48801
- MyMichigan Medical Center Gratiot
-
Ann Arbor, Michigan, Forenede Stater, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Brighton, Michigan, Forenede Stater, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Brighton, Michigan, Forenede Stater, 48114
- Trinity Health Medical Center - Brighton
-
Canton, Michigan, Forenede Stater, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Canton, Michigan, Forenede Stater, 48188
- Trinity Health Medical Center - Canton
-
Caro, Michigan, Forenede Stater, 48723
- Caro Cancer Center
-
Chelsea, Michigan, Forenede Stater, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Chelsea, Michigan, Forenede Stater, 48118
- Chelsea Hospital
-
Clarkston, Michigan, Forenede Stater, 48346
- Hematology Oncology Consultants-Clarkston
-
Clarkston, Michigan, Forenede Stater, 48346
- Newland Medical Associates-Clarkston
-
Detroit, Michigan, Forenede Stater, 48236
- Henry Ford Health Saint John Hospital
-
East China Township, Michigan, Forenede Stater, 48054
- Henry Ford River District Hospital
-
Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
-
Flint, Michigan, Forenede Stater, 48503
- Genesee Hematology Oncology PC
-
Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
-
Flint, Michigan, Forenede Stater, 48503
- Cancer Hematology Centers - Flint
-
Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Henry Ford Saint John Hospital - Academic
-
Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Henry Ford Saint John Hospital - Breast
-
Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Henry Ford Saint John Hospital - Van Elslander
-
Lansing, Michigan, Forenede Stater, 48912
- University of Michigan Health - Sparrow Lansing
-
Livonia, Michigan, Forenede Stater, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Livonia, Michigan, Forenede Stater, 48154
- Hope Cancer Clinic
-
Macomb, Michigan, Forenede Stater, 48044
- Henry Ford Warren Hospital - Breast Macomb
-
Macomb, Michigan, Forenede Stater, 48044
- Henry Ford Saint John Hospital - Macomb Medical
-
Marlette, Michigan, Forenede Stater, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
-
Midland, Michigan, Forenede Stater, 48670
- MyMichigan Medical Center Midland
-
Pontiac, Michigan, Forenede Stater, 48341
- Hope Cancer Center
-
Pontiac, Michigan, Forenede Stater, 48341
- Newland Medical Associates-Pontiac
-
Pontiac, Michigan, Forenede Stater, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Pontiac, Michigan, Forenede Stater, 48341
- Michigan Healthcare Professionals Pontiac
-
Rochester Hills, Michigan, Forenede Stater, 48309
- Henry Ford Rochester Hospital
-
Saginaw, Michigan, Forenede Stater, 48604
- Oncology Hematology Associates of Saginaw Valley PC
-
Saginaw, Michigan, Forenede Stater, 48601
- MyMichigan Medical Center Saginaw
-
Sterling Heights, Michigan, Forenede Stater, 48312
- Bhadresh Nayak MD PC-Sterling Heights
-
Tawas City, Michigan, Forenede Stater, 48764
- MyMichigan Medical Center Tawas
-
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 Branch, Michigan, Forenede Stater, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
-
Ypsilanti, Michigan, Forenede Stater, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Ypsilanti, Michigan, Forenede Stater, 48106
- Huron Gastroenterology PC
-
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Minnesota
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Bemidji, Minnesota, Forenede Stater, 56601
- Sanford Joe Lueken Cancer Center
-
Brainerd, Minnesota, Forenede Stater, 56401
- Essentia Health Saint Joseph's Medical Center
-
Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
-
Burnsville, Minnesota, Forenede Stater, 55337
- Minnesota Oncology - Burnsville
-
Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
-
Deer River, Minnesota, Forenede Stater, 56636
- Essentia Health - Deer River Clinic
-
Detroit Lakes, Minnesota, Forenede Stater, 56501
- Essentia Health Saint Mary's - Detroit Lakes Clinic
-
Duluth, Minnesota, Forenede Stater, 55805
- Essentia Health Cancer Center
-
Duluth, Minnesota, Forenede Stater, 55805
- Essentia Health Saint Mary's Medical Center
-
Duluth, Minnesota, Forenede Stater, 55805
- Miller-Dwan Hospital
-
Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, Forenede Stater, 56537
- Lake Region Healthcare Corporation-Cancer Care
-
Fosston, Minnesota, Forenede Stater, 56542
- Essentia Health - Fosston
-
Fridley, Minnesota, Forenede Stater, 55432
- Unity Hospital
-
Hibbing, Minnesota, Forenede Stater, 55746
- Essentia Health Hibbing Clinic
-
Maple Grove, Minnesota, Forenede Stater, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, Forenede Stater, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Forenede Stater, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Forenede Stater, 55454
- Health Partners Inc
-
Monticello, Minnesota, Forenede Stater, 55362
- Monticello Cancer Center
-
New Ulm, Minnesota, Forenede Stater, 56073
- New Ulm Medical Center
-
Park Rapids, Minnesota, Forenede Stater, 56470
- Essentia Health - Park Rapids
-
Robbinsdale, Minnesota, Forenede Stater, 55422
- North Memorial Medical Health Center
-
Saint Cloud, Minnesota, Forenede Stater, 56303
- Coborn Cancer Center at Saint Cloud Hospital
-
Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
-
Sandstone, Minnesota, Forenede Stater, 55072
- Essentia Health Sandstone
-
Shakopee, Minnesota, Forenede Stater, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Forenede Stater, 55082
- Lakeview Hospital
-
Thief River Falls, Minnesota, Forenede Stater, 56701
- Sanford Thief River Falls Medical Center
-
Virginia, Minnesota, Forenede Stater, 55792
- Essentia Health Virginia Clinic
-
Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Forenede Stater, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Worthington, Minnesota, Forenede Stater, 56187
- Sanford Cancer Center Worthington
-
Wyoming, Minnesota, Forenede Stater, 55092
- Fairview Lakes 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
-
Cape Girardeau, Missouri, Forenede Stater, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Forenede Stater, 63703
- Mercy Cancer Center - Cape Girardeau
-
Columbia, Missouri, Forenede Stater, 65212
- MU Health - University Hospital/Ellis Fischel Cancer Center
-
Creve Coeur, Missouri, Forenede Stater, 63141
- Siteman Cancer Center at West County Hospital
-
Farmington, Missouri, Forenede Stater, 63640
- Parkland Health Center - Farmington
-
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
-
Osage Beach, Missouri, Forenede Stater, 65065
- Lake Regional Hospital
-
Rolla, Missouri, Forenede Stater, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, Forenede Stater, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, Forenede Stater, 64506
- Heartland Regional Medical Center
-
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, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, Forenede Stater, 63136
- Siteman Cancer Center at Christian Hospital
-
St Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Forenede Stater, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Forenede Stater, 63128
- Mercy Hospital South
-
Sullivan, Missouri, Forenede Stater, 63080
- Missouri Baptist Sullivan Hospital
-
Sunset Hills, Missouri, Forenede Stater, 63127
- BJC Outpatient Center at Sunset Hills
-
-
Montana
-
Anaconda, Montana, Forenede Stater, 59711
- Community Hospital of Anaconda
-
Billings, Montana, Forenede Stater, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Forenede Stater, 59715
- Bozeman Health Deaconess Hospital
-
Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic
-
Great Falls, Montana, Forenede Stater, 59405
- Benefis Sletten Cancer Institute
-
Havre, Montana, Forenede Stater, 59501
- Hi-Line Sletten Cancer Center
-
Helena, Montana, Forenede Stater, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, Forenede Stater, 59901
- Logan Health Medical Center
-
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, 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
-
-
New Jersey
-
Basking Ridge, New Jersey, Forenede Stater, 07920
- Memorial Sloan Kettering Basking Ridge
-
Englewood, New Jersey, Forenede Stater, 07631
- Englewood Hospital and Medical Center
-
Middletown, New Jersey, Forenede Stater, 07748
- Memorial Sloan Kettering Monmouth
-
Montvale, New Jersey, Forenede Stater, 07645
- Memorial Sloan Kettering Bergen
-
-
New York
-
Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
-
Commack, New York, Forenede Stater, 11725
- Memorial Sloan Kettering Commack
-
Harrison, New York, Forenede Stater, 10604
- Memorial Sloan Kettering Westchester
-
New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, Forenede Stater, 10065
- NYP/Weill Cornell Medical Center
-
New York, New York, Forenede Stater, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Oswego, New York, Forenede Stater, 13126
- Upstate Cancer Center at Oswego
-
Oswego, New York, Forenede Stater, 13126
- Upstate Cancer Center Radiation Oncology at Oswego
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester
-
Syracuse, New York, Forenede Stater, 13210
- State University of New York Upstate Medical University
-
Uniondale, New York, Forenede Stater, 11553
- Memorial Sloan Kettering Nassau
-
Verona, New York, Forenede Stater, 13478
- Upstate Cancer Center at Verona
-
-
North Carolina
-
Clinton, North Carolina, Forenede Stater, 28328
- Southeastern Medical Oncology Center-Clinton
-
Goldsboro, North Carolina, Forenede Stater, 27534
- Southeastern Medical Oncology Center-Goldsboro
-
Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Memorial Hospital
-
Jacksonville, North Carolina, Forenede Stater, 28546
- Southeastern Medical Oncology Center-Jacksonville
-
Jacksonville, North Carolina, Forenede Stater, 28546
- Onslow Memorial Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Forenede Stater, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, Forenede Stater, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Forenede Stater, 58103
- Essentia Health Cancer Center-South University Clinic
-
Fargo, North Dakota, Forenede Stater, 58122
- Sanford Broadway Medical Center
-
Fargo, North Dakota, Forenede Stater, 58103
- Sanford South University Medical Center
-
Fargo, North Dakota, Forenede Stater, 58104
- Sanford Medical Center Fargo
-
Jamestown, North Dakota, Forenede Stater, 58401
- Essentia Health - Jamestown Clinic
-
-
Ohio
-
Beavercreek, Ohio, Forenede Stater, 45431
- Indu and Raj Soin Medical Center
-
Boardman, Ohio, Forenede Stater, 44512
- Saint Elizabeth Boardman Hospital
-
Centerville, Ohio, Forenede Stater, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, Forenede Stater, 45459
- Dayton Physicians LLC-Miami Valley South
-
Cincinnati, Ohio, Forenede Stater, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Forenede Stater, 45242
- Bethesda North Hospital
-
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, 44195
- Cleveland Clinic Foundation
-
Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Comprehensive Cancer Center
-
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, 45415
- Dayton Physician LLC - Englewood
-
Dayton, Ohio, Forenede Stater, 45409
- Premier Blood and Cancer Center
-
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
-
Greenville, Ohio, Forenede Stater, 45331
- Miami Valley Cancer Care and Infusion
-
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
-
Springfield, Ohio, Forenede Stater, 45504
- Springfield Regional Cancer Center
-
Springfield, Ohio, Forenede Stater, 45504
- Springfield Regional Medical Center
-
Troy, Ohio, Forenede Stater, 45373
- Upper Valley Medical Center
-
Troy, Ohio, Forenede Stater, 45373
- Dayton Physicians LLC - Troy
-
Warren, Ohio, Forenede Stater, 44484
- Saint Joseph Warren Hospital
-
Youngstown, Ohio, Forenede Stater, 44501
- Saint Elizabeth Youngstown Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Forenede Stater, 73120
- Mercy Hospital Oklahoma City
-
Tulsa, Oklahoma, Forenede Stater, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
-
Oregon
-
Baker City, Oregon, Forenede Stater, 97814
- Saint Alphonsus Cancer Care Center-Baker City
-
Ontario, Oregon, Forenede Stater, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
-
Pennsylvania
-
Allentown, Pennsylvania, Forenede Stater, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Forenede Stater, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Medical Center
-
East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Pocono Medical Center
-
Hazleton, Pennsylvania, Forenede Stater, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Hazleton, Pennsylvania, Forenede Stater, 18201
- Lehigh Valley Hospital-Hazleton
-
Lewisburg, Pennsylvania, Forenede Stater, 17837
- Geisinger Medical Oncology-Lewisburg
-
Lewistown, Pennsylvania, Forenede Stater, 17044
- Lewistown Hospital
-
Pottsville, Pennsylvania, Forenede Stater, 17901
- Geisinger Cancer Services-Pottsville
-
Scranton, Pennsylvania, Forenede Stater, 18510
- Community Medical Center
-
Selinsgrove, Pennsylvania, Forenede Stater, 17870
- Geisinger Medical Oncology-Selinsgrove
-
Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
-
-
South Carolina
-
Boiling Springs, South Carolina, Forenede Stater, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
-
Clinton, South Carolina, Forenede Stater, 29325
- Prisma Health Cancer Institute - Laurens
-
Easley, South Carolina, Forenede Stater, 29640
- Prisma Health Cancer Institute - Easley
-
Gaffney, South Carolina, Forenede Stater, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, Forenede Stater, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Forenede Stater, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Forenede Stater, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, Forenede Stater, 29605
- Prisma Health Greenville Memorial Hospital
-
Greer, South Carolina, Forenede Stater, 29650
- Prisma Health Cancer Institute - Greer
-
Greer, South Carolina, Forenede Stater, 29651
- Gibbs Cancer Center-Pelham
-
Seneca, South Carolina, Forenede Stater, 29672
- Prisma Health Cancer Institute - Seneca
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Medical Center
-
Union, South Carolina, Forenede Stater, 29379
- SMC Center for Hematology Oncology Union
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Forenede Stater, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Chattanooga, Tennessee, Forenede Stater, 37404
- Memorial Hospital
-
Hixson, Tennessee, Forenede Stater, 37343
- Pulmonary Medicine Center of Chattanooga-Hixson
-
Ooltewah, Tennessee, Forenede Stater, 37363
- Memorial GYN Plus
-
-
Texas
-
Bryan, Texas, Forenede Stater, 77802
- Saint Joseph Regional Cancer Center
-
Dallas, Texas, Forenede Stater, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Forenede Stater, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Dallas, Texas, Forenede Stater, 75237
- UT Southwestern Simmons Cancer Center - RedBird
-
Fort Worth, Texas, Forenede Stater, 76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Richardson, Texas, Forenede Stater, 75080
- UT Southwestern Clinical Center at Richardson/Plano
-
-
Washington
-
Burien, Washington, Forenede Stater, 98166
- Highline Medical Center-Main Campus
-
Enumclaw, Washington, Forenede Stater, 98022
- Saint Elizabeth Hospital
-
Federal Way, Washington, Forenede Stater, 98003
- Saint Francis Hospital
-
Lakewood, Washington, Forenede Stater, 98499
- Saint Clare Hospital
-
Poulsbo, Washington, Forenede Stater, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Silverdale, Washington, Forenede Stater, 98383
- Saint Michael Cancer Center
-
Tacoma, Washington, Forenede Stater, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, Forenede Stater, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
-
West Virginia
-
Bridgeport, West Virginia, Forenede Stater, 26330
- United Hospital Center
-
Martinsburg, West Virginia, Forenede Stater, 25401
- WVUH-Berkely Medical Center
-
Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University Healthcare
-
Parkersburg, West Virginia, Forenede Stater, 26101
- Camden Clark Medical Center
-
-
Wisconsin
-
Antigo, Wisconsin, Forenede Stater, 54409
- Langlade Hospital and Cancer Center
-
Ashland, Wisconsin, Forenede Stater, 54806
- Duluth Clinic Ashland
-
Ashland, Wisconsin, Forenede Stater, 54806
- Northwest Wisconsin Cancer Center
-
Eau Claire, Wisconsin, Forenede Stater, 54701
- Marshfield Medical Center-EC Cancer Center
-
Hayward, Wisconsin, Forenede Stater, 54843
- Essentia Health-Hayward Clinic
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Medical Center
-
Ladysmith, Wisconsin, Forenede Stater, 54848
- Marshfield Medical Center - Ladysmith
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Medical Center-Marshfield
-
Medford, Wisconsin, Forenede Stater, 54451
- Aspirus Medford Hospital
-
Minocqua, Wisconsin, Forenede Stater, 54548
- Marshfield Medical Center - Minocqua
-
New Richmond, Wisconsin, Forenede Stater, 54017
- Cancer Center of Western Wisconsin
-
Rhinelander, Wisconsin, Forenede Stater, 54501
- Aspirus Cancer Care - James Beck Cancer Center
-
Rice Lake, Wisconsin, Forenede Stater, 54868
- Marshfield Medical Center-Rice Lake
-
Spooner, Wisconsin, Forenede Stater, 54801
- Essentia Health-Spooner Clinic
-
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
-
Superior, Wisconsin, Forenede Stater, 54880
- Essentia Health Saint Mary's Hospital - Superior
-
Wausau, Wisconsin, Forenede Stater, 54401
- Aspirus Regional Cancer Center
-
Weston, Wisconsin, Forenede Stater, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
- Aspirus Cancer Care - Wisconsin Rapids
-
-
Wyoming
-
Cheyenne, Wyoming, Forenede Stater, 82001
- Memorial Hospital of Laramie County
-
Cody, Wyoming, Forenede Stater, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, Forenede Stater, 82801
- Welch Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Trin 1 Patientregistreringskriterier
- Histologisk bekræftet muskelinvasiv urothelial carcinom i blæren. Urothelial carcinom, der trænger ind i prostatastroma uden histologisk muskelinvasion, er tilladt, forudsat at omfanget af sygdommen bekræftes via billeddannelse og/eller undersøgelse under anæstesi (EUA). Den diagnostiske TURBT-prøve skal være opnået inden for 60 dage før registrering
- 20 ufarvede objektglas (10 mikron tykkelse) af formalinfikseret paraffinindlejret (FFPE) præ-behandling diagnostisk transurethral resektion (TUR) prøve tilgængelig (til sekventering), med 2 (5 mikron) objektglas i starten og slutningen af de 20 objektglas , for i alt 22 ufarvede objektglas. En FFPE-blok er også acceptabel
- Klinisk stadium T2-T4aN0/xM0 sygdom
- Medicinsk passende kandidat til radikal cystektomi vurderet af kirurg
- Intet samtidig multifokalt karcinom in situ; et enkelt fokus er tilladt
- En enkelt muskelinvasiv blæretumor, der måler ≤5 cm i størrelse som defineret af kirurgerne ved cystoskopisk evaluering. Når det er dokumenteret, vil patologisk størrelse ved cystoskopi og TURBT have forrang over radiografiske målinger af tumorstørrelse.
- Ingen klinisk eller radiografisk evidens for lokalt fremskreden eller metastatisk sygdom
- Ingen tidligere anti-PD-1- eller anti-PD-L1-terapier eller systemisk kemoterapi inden for de seneste 5 år (tidligere intravesikal induktionsimmunterapi til ikke-muskelinvasiv sygdom er tilladt, defineret som BCG x6 doser og vedligeholdelsesterapi); BCG-refraktær sygdom, defineret som sygdomstilbagefald inden for 3 måneder efter BCG-behandling, er ikke tilladt. Intravesikal kemoterapi er tilladt.
- Ingen forudgående strålebehandling af blæren eller prostata
- Ingen større operation eller strålebehandling =< 4 ugers registrering (TURBT er tilladt).
- Ikke gravid og ikke ammende. Denne undersøgelse involverer et middel, der har kendt genotoksiske, mutagene og teratogene virkninger. Kun for kvinder i den fødedygtige alder kræves en negativ graviditetstest udført =< 14 dage før registrering
- Eastern Cooperative Oncology Group (ECOG) præstationsstatus 0-1
- Absolut neutrofiltal (ANC) >= 1.000/mm^3
- Blodpladetal >= 100.000/mm^3
- Beregnet kreatininclearance ≥ 55 ml/min ved brug af formel efter institutionel standard eller investigators skøn. Den samme formel skal bruges til at beregne alle efterfølgende kreatininclearances.
Total bilirubin =< 1,5 x øvre normalgrænse (ULN)
* (For patienter med dokumenteret Gilberts syndrom Total Bilirubin =< 3 x ULN)
- Aspartataminotransferase (AST)/alaninaminotransferase (ALT) =< 2,5 x ULN
- Alkalisk fosfatase =< 2,5 x ULN
- Ingen tegn på New York Heart Association (NYHA) funktionel klasse III eller IV hjertesygdom
- Ingen igangværende hjerterytmeforstyrrelser fra National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grad >= 2
- Ingen allerede eksisterende sensorisk grad >= 2 neuropati
- Ingen allerede eksisterende grad >= 2 høretab
- Ingen alvorlig interkurrent medicinsk eller psykiatrisk sygdom, herunder alvorlig aktiv infektion
- Ingen af følgende inden for de 6 måneder forud for administration af studiets lægemiddel: myokardieinfarkt, svær/ustabil angina, koronar/perifer arterie bypassgraft, symptomatisk kongestiv hjertesvigt, cerebrovaskulær ulykke eller forbigående iskæmisk anfald
- Ingen kendt human immundefektvirus (HIV) eller erhvervet immundefektsyndrom (AIDS)-relateret sygdom eller anden aktiv infektion. HIV-positive patienter i antiretroviral kombinationsbehandling er ikke kvalificerede på grund af potentialet for farmakokinetiske interaktioner med de lægemidler, der anvendes i dette forsøg. Derudover har disse patienter øget risiko for dødelige infektioner, når de behandles med marvsuppressiv terapi. Der vil blive udført passende undersøgelser af patienter, der får antiretroviral kombinationsbehandling, når det er indiceret
- Ingen historie med allergisk reaktion tilskrevet forbindelser med lignende kemisk eller biologisk sammensætning som de midler, der blev brugt i denne undersøgelse
- Ingen samtidig behandling i et andet klinisk forsøg; forsøg med støttende behandling eller ikke-terapeutiske forsøg (f.eks. livskvalitet) er tilladt
- Ingen tidligere malignitet bortset fra: tilstrækkeligt behandlet basal- eller pladecellehudkræft, in situ livmoderhalskræft, tilstrækkeligt behandlet stadium I eller II kræft, hvor patienten i øjeblikket er i fuldstændig remission, eller enhver anden kræftsygdom, som patienten har været sygdomsfri i fem år. Patienter med lokaliseret prostatacancer, som følges af et aktivt overvågningsprogram, er også berettigede
- Trin 2 Patientregistreringskriterier
- Patienter skal have gennemført 4 eller flere cyklusser med protokolstyret kemoterapi, og DDR-genresultater skal være tilgængelige
- Trin 3 Patientregistrering Kvalificeringskriterier (kun patienter med en DDR-genændring)
- Skadelig ændring inden for 1 eller flere af 9 foruddefinerede DDR-gener i forbehandlingens TURBT-deoxyribonukleinsyre (DNA)
- Cystoskopi og billeddiagnostik udført for at bestemme fase/behandlingstildeling
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm I (gemcitabin, cisplatin, blærebesparende)
Deltagerne får gemcitabinhydrochlorid IV i løbet af 30 minutter på dag 1, cisplatin IV på dag 1 og 2 og pegfilgrastim SC på dag 3. Behandlingen gentages hver 14. dag i op til 6 forløb i fravær af sygdomsprogression eller uaccepteret toksicitet.
Deltagere med DDR-genændring og sygdomsstadium < cT1 gennemgår blæresparing.
|
Givet IV
Givet IV
Givet SC
Gennemgå blæresparing
|
|
Eksperimentel: Arm II (gemcitabin, cisplatin, cystektomi, kemoradioterapi)
Deltagerne får gemcitabinhydrochlorid IV i løbet af 30 minutter på dag 1, cisplatin IV på dag 1 og 2 og pegfilgrastim SC på dag 3. Behandlingen gentages hver 14. dag i op til 6 forløb i fravær af sygdomsprogression eller uaccepteret toksicitet.
Deltagere med DDR-genændring og sygdomsstadium >= cT1 eller deltagere uden DDR-genændring gennemgår radikal cystektomi eller kemoradioterapi.
|
Givet IV
Givet IV
Givet SC
Gennemgå radikal cystektomi
Gennemgå kemoradioterapi
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Andel af patienter, der er tilbagefaldsfri inden for den DDR-muterede gruppe, som gennemgår blærebesparende tilgang
Tidsramme: På 3 år
|
Vil bruge Kaplan Meier overlevelsesanalyse til at estimere andelen af patienter, der er tilbagefaldsfri efter tre år.
Vil bruge et ensidigt 90 % konfidensinterval.
|
På 3 år
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Klinisk responsrate for patienter med skadelige DDR-genændringer
Tidsramme: Efter 6 kurser (84 dage)
|
Vil blive defineret som antallet af patienter med mindre end et cT1-respons divideret med det samlede antal patienter med skadelige DDR-genændringer, som fuldførte 6 cyklusser med dosistæt gemcitabin og cisplatin.
|
Efter 6 kurser (84 dage)
|
|
Blære-intakt overlevelse hos DDR-ændrede patienter med < cT1-responser, som valgte blærebesparende tilgang
Tidsramme: Tid fra registrering op til 5 år
|
Vil blive estimeret med Kaplan-Meier estimatorer og tilsvarende 95 % konfidensintervaller.
|
Tid fra registrering op til 5 år
|
|
Samlet overlevelse
Tidsramme: Tid fra studietilmelding op til 5 år
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Vil blive estimeret med Kaplan-Meier estimatorer og tilsvarende 95 % konfidensintervaller.
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Tid fra studietilmelding op til 5 år
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Patologisk respons (pT0) rate ved cystektomi hos deltagere uden DDR-genændringer
Tidsramme: Op til 5 år
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Dette vil være antallet af patienter uden DDR-genændringer med pT0 ved cystektomi divideret med antallet af patienter uden DDR-genændringer, som har gennemgået cystektomi efter afslutning af dosistæt gemcitabin- og cisplatinbehandling.
Vil blive estimeret med et binomialt punktestimat og tilsvarende 95 % binomiale konfidensintervaller.
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Op til 5 år
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Overlevelse uden gentagelse
Tidsramme: Tid fra studietilmelding op til 5 år
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Kaplan-Meier-estimatoren vil blive brugt til at estimere andelen af patienter, som har succesfrit tilbagefald efter tre år under de to alternative definitioner på gentagelsesfri succes ovenfor.
Punktestimatet for den treårige gentagelsesfri overlevelsesrate vil blive rapporteret med et 95 % konfidensinterval.
Disse analyser vil også blive gentaget for 5-års gentagelsesfri overlevelse.
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Tid fra studietilmelding op til 5 år
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Hyppigheden af cystektomier hos patienter med en DDR-ændring og med et cT0/CIS/Ta-respons
Tidsramme: Inden for 3 år
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Vil blive beregnet som antallet af patienter med en DDR-ændring og med et cT0/CIS/Ta-respons, der gennemgår en cystektomi inden for 3 år divideret med det samlede antal patienter med en DDR-ændring og med et cT0/CIS/Ta-respons.
Vil blive estimeret med et binomialt punktestimat og tilsvarende 95 % binomiale konfidensintervaller.
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Inden for 3 år
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Andel af patienter i den blærebesparende gruppe, som gennemgår lokal terapi
Tidsramme: Op til 5 år
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Vil blive estimeret med et binomialt punktestimat og 95 % binomialt konfidensinterval.
Estimatet vil blive bestemt som antallet af patienter, der gennemgår lokal behandling (BCG eller resektion af ikke-invasiv sygdom) i den blærebesparende gruppe divideret med det samlede antal patienter i den blærebesparende gruppe.
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Op til 5 år
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Gopa Iyer, MD, Memorial Sloan Kettering Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Karcinom
- Carcinom, overgangscelle
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Terapeutik
- Kirurgiske procedurer, operative
- Lægemiddelterapi
- Uorganiske kemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Deoxycytidin
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Platinforbindelser
- Strålebehandling
- Urologiske kirurgiske procedurer
- Urogenitale kirurgiske procedurer
- Kombineret modalitetsterapi
- Gemcitabin
- Cisplatin
- Kemoradioterapi
- Pegfilgrastim
- Cystektomi
Andre undersøgelses-id-numre
- A031701
- U10CA180821 (U.S. NIH-bevilling/kontrakt)
- NCI-2018-01531 (Registry Identifier: NCI Clinical Trial Reporting Program)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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 Infiltrerende blære Urothelial Carcinom
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk blæreurothelial karcinom | Metastatisk nyrebækken Urothelial Carcinom | Metastatisk Ureter Urothelial Carcinoma | Metastatisk Urethral Urothelial Carcinoma | Metastatisk Urothelial Carcinom | Lokalt avanceret blæreurothelial karcinom | Lokalt avanceret nyrebækken Urothelial Carcinoma | Lokalt... og andre forholdForenede Stater
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National Cancer Institute (NCI)AfsluttetMetastatisk blæreurothelial karcinom | Metastatisk Ureter Urothelial Carcinoma | Stadie IV Blære Urothelial Carcinoma AJCC v7 | Metastatisk nyrebækken og Ureter Urothelial CarcinomaForenede Stater
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Roswell Park Cancer InstituteIovance Biotherapeutics, Inc.Trukket tilbageMetastatisk blæreurothelial karcinom | Metastatisk nyrebækken Urothelial Carcinom | Metastatisk Ureter Urothelial Carcinoma | Metastatisk Urethral Urothelial Carcinoma | Uoperabelt nyrebækken Urothelial Carcinom | Uoperabelt Ureter Urothelial CarcinomaForenede Stater
-
Tyra Biosciences, IncRekrutteringLow Grade Upper Tract Urothelial CarcinomaForenede Stater
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Changhai HospitalAktiv, ikke rekrutterendeNeoadjuverende terapi | Urothelial Carcinoma Ureter | Øvre urinvejsurothelial karcinomKina
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Barbara Ann Karmanos Cancer InstituteBristol-Myers SquibbAfsluttetStadie III Blære Urothelial Carcinoma AJCC v6 og v7 | Stadie IV Blære Urothelial Carcinoma AJCC v7 | Stadie II Blære Urothelial Carcinoma AJCC v6 og v7Forenede Stater
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk Urothelial Carcinom | Stadie III Blære Urothelial Carcinoma AJCC v6 og v7 | Stadie IV Blære Urothelial Carcinoma AJCC v7 | Lokalt avanceret Urothelial Carcinom | Tilbagevendende Urothelial Carcinom | Uoperabelt Urothelial Carcinom | Avanceret Urothelial CarcinomForenede Stater
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk blæreurothelial karcinom | Metastatisk nyrebækken Urothelial Carcinom | Metastatisk Ureter Urothelial Carcinoma | Metastatisk Urethral Urothelial Carcinoma | Tilbagevendende blære-urothelial carcinom | Tilbagevendende nyrebækken Urothelial Carcinom | Tilbagevendende Ureter Urothelial Carcinoma og andre forholdForenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendePemetrexed og Avelumab til behandling af patienter med MTAP-mangelfuld metastatisk urothelial cancerMetastatisk Urothelial Carcinom | Infiltrerende blære Urothelial Carcinoma, Plasmacytoid Variant | Infiltrerende blære Urothelial Carcinoma Sarcomatoid Variant | Infiltrerende blære-urothelial karcinom med kirteldifferentiering | Infiltrerende blære-urothelial carcinom med pladeepitel-differentiering og andre forholdForenede Stater
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National Cancer Institute (NCI)RekrutteringNyrebækken og Ureter Urothelial CarcinomaForenede Stater
Kliniske forsøg med Cisplatin
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West China Second University HospitalRekrutteringNeoadjuverende kemoterapi | Epitelkarcinom, ovarieKina
-
Insmed IncorporatedAfsluttetOsteosarkom MetastatiskForenede Stater
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London Health Sciences Centre Research Institute...RekrutteringLokalt avanceret hoved- og halspladecellekarcinomCanada
-
Privo TechnologiesNational Cancer Institute (NCI)AfsluttetOralt planocellulært karcinomForenede Stater
-
Taiho Oncology, Inc.Quintiles, Inc.AfsluttetMavekræftForenede Stater, Canada
-
Cedars-Sinai Medical CenterAktiv, ikke rekrutterendeHPV-positivt orofaryngealt planocellulært karcinomForenede Stater
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Sun Yat-sen UniversityAktiv, ikke rekrutterendeNasopharyngealt karcinomKina
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Bangabandhu Sheikh Mujib Medical University, Dhaka...Afsluttet
-
Taiho Pharmaceutical Co., Ltd.AfsluttetLivmoderhalskræftJapan, Korea, Republikken, Taiwan
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Fujian Cancer HospitalIkke rekrutterer endnuNasopharyngealt karcinomKina