En undersøgelse af Amivantamab og mFOLFOX6 eller FOLFIRI versus Cetuximab og mFOLFOX6 eller FOLFIRI som førstelinjebehandling hos deltagere med KRAS/NRAS og BRAF Vildtype uoperabel eller metastatisk venstresidig kolorektal cancer (OrigAMI-2)
Et randomiseret, åbent fase 3-studie af Amivantamab og mFOLFOX6 eller FOLFIRI versus Cetuximab og mFOLFOX6 eller FOLFIRI som førstelinjebehandling hos deltagere med KRAS/NRAS og BRAF Vildtype uoperabel eller metastatisk venstresidig kolorektal cancer
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Udvidet adgang
Udvidet adgang
Godkendt
- Tilgængelig: Udvidet adgang er i øjeblikket tilgængelig for denne forsøgsbehandling, og patienter, der ikke er deltagere i den kliniske undersøgelse, kan muligvis få adgang til lægemidlet, det biologiske eller medicinske udstyr undersøgt.
- Ikke længere tilgængelig: Udvidet adgang var tilgængelig for denne intervention tidligere, men er ikke tilgængelig i øjeblikket og vil ikke være tilgængelig i fremtiden.
- Midlertidigt ikke tilgængelig: Udvidet adgang er i øjeblikket ikke tilgængelig for denne intervention, men forventes at være tilgængelig i fremtiden.
- Godkendt til markedsføring: Interventionen er blevet godkendt af U.S. Food and Drug Administration til brug for offentligheden.
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Anderlecht, Belgien, 1070
- Rekruttering
- Institut Jules Bordet
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Edegem, Belgien, 2650
- Rekruttering
- Universitair Ziekenhuis Antwerpen
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Ghent, Belgien, 9000
- Aktiv, ikke rekrutterende
- AZ Maria Middelares
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Haine Saint Paul La Louviere, Belgien, 7100
- Rekruttering
- Hopital de Jolimont
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Kortrijk, Belgien, 8500
- Rekruttering
- Az Groeninge
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Leuven, Belgien, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven
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Liège, Belgien, 4000
- Rekruttering
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
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Barretos, Brasilien, 14780 070
- Rekruttering
- Fundacao Pio XII
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Caxias do Sul, Brasilien, 95070 560
- Rekruttering
- Fundacao Universidade de Caxias do Sul
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Jaú, Brasilien, 17210 080
- Rekruttering
- Fundacao Doutor Amaral Carvalho
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Porto Alegre, Brasilien, 91350 200
- Rekruttering
- Hospital Nossa Senhora da Conceicao S A
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Salvador, Brasilien, 40050 410
- Rekruttering
- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
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Santa Maria, Brasilien, 97015 450
- Rekruttering
- Clinica de Hematologia e Oncologia Viver Ltda
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São José do Rio Preto, Brasilien, 15090-000
- Rekruttering
- Funfarme Sjrp
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São Paulo, Brasilien, 01246 000
- Rekruttering
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brasilien, 01509 900
- Rekruttering
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasilien, 05651 900
- Rekruttering
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Vitória, Brasilien, 29043 260
- Rekruttering
- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Rekruttering
- Arthur J E Child Comprehensive Cancer Centre
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Rekruttering
- Ottawa Hospital
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Toronto, Ontario, Canada, M5G1X6
- Rekruttering
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H2X 0C1
- Rekruttering
- Centre de Recherche du CHUM
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Birmingham, Det Forenede Kongerige, B9 5ST
- Rekruttering
- Birmingham Heartlands Hospital
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Cambridge, Det Forenede Kongerige, CB2 0QQ
- Rekruttering
- Addenbrooke's Hospital
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Edinburgh, Det Forenede Kongerige, EH4 2XU
- Rekruttering
- Western General Hospital
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Hull, Det Forenede Kongerige, HU16 5JQ
- Rekruttering
- Castle Hill Hospital
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Leeds, Det Forenede Kongerige, LS9 7TF
- Rekruttering
- St James University Hospital
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London, Det Forenede Kongerige, EC1A 7BE
- Rekruttering
- St Bartholomew's Hospital
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London, Det Forenede Kongerige, NW1 2BU
- Rekruttering
- University College Hospital
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Northwood, Det Forenede Kongerige, HA6 2RN
- Rekruttering
- Mount Vernon Cancer Centre
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Sutton, Det Forenede Kongerige, SM2 5PT
- Rekruttering
- Royal Marsden Hospital (Sutton)
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Arizona
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Gilbert, Arizona, Forenede Stater, 85234
- Rekruttering
- Banner MD Anderson Cancer Center
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Arkansas
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Jonesboro, Arkansas, Forenede Stater, 72401
- Rekruttering
- St. Bernard's Medical Center
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Springdale, Arkansas, Forenede Stater, 72762
- Rekruttering
- Highlands Oncology Group
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California
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Bakersfield, California, Forenede Stater, 93309
- Rekruttering
- CBCC Global Research
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Glendale, California, Forenede Stater, 91204
- Rekruttering
- Los Angeles Cancer Network
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Los Alamitos, California, Forenede Stater, 90720
- Rekruttering
- Cancer and Blood Specialty Clinic
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Los Angeles, California, Forenede Stater, 90033
- Rekruttering
- USC Norris Comprehensive Cancer Center
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Santa Monica, California, Forenede Stater, 90404
- Rekruttering
- UCLA
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Santa Rosa, California, Forenede Stater, 95403
- Rekruttering
- Providence Medical Foundation
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Torrance, California, Forenede Stater, 90505
- Rekruttering
- Torrance Memorial Physicians Network
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- Rekruttering
- Rocky Mountain Cancer Centers
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06519
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- Yale University School Of Medicine
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- Rekruttering
- Georgetown Univ Medical Center Lombardi Cancer Center
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Florida
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Fort Myers, Florida, Forenede Stater, 33901
- Rekruttering
- Florida Cancer Specialists South
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Orlando, Florida, Forenede Stater, 32804
- Rekruttering
- AdventHealth Medical Group Oncology and Hematology at Orlando
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St. Petersburg, Florida, Forenede Stater, 33701-4553
- Rekruttering
- Florida Cancer Specialists North Region
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West Palm Beach, Florida, Forenede Stater, 33401-3406
- Rekruttering
- Florida Cancer Specialists East
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
- Rekruttering
- Grady Memorial Hospital
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Winship Cancer Institute Emory University
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60005
- Rekruttering
- Illinois Cancer Specialists
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Peoria, Illinois, Forenede Stater, 61615
- Rekruttering
- Illinois CancerCare
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46804
- Rekruttering
- Fort Wayne Medical Oncology & Hematology
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- University of Iowa Hospital
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Waukee, Iowa, Forenede Stater, 50263
- Rekruttering
- Mission Cancer Blood
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Kansas
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Wichita, Kansas, Forenede Stater, 67214
- Rekruttering
- Cancer Center of Kansas
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70121
- Rekruttering
- Ochsner Clinic Foundation
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Maryland
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Baltimore, Maryland, Forenede Stater, 21237
- Rekruttering
- MedStar Franklin Square Medical Center
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Frederick, Maryland, Forenede Stater, 21702-4337
- Rekruttering
- Frederick Health Hospital - James M Stockman Cancer Institute
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- Rekruttering
- University of Michigan
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Ann Arbor, Michigan, Forenede Stater, 48105
- Rekruttering
- VA Ann Arbor Healthcare System
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Detroit, Michigan, Forenede Stater, 48202
- Rekruttering
- Henry Ford Hospital
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Grand Rapids, Michigan, Forenede Stater, 49503
- Rekruttering
- Cancer And Hematology Centers of Western Michigan PC
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39401
- Rekruttering
- Hattiesburg Clinic
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University School Of Medicine
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68130
- Rekruttering
- Nebraska Cancer Specialists Midwest Cancer Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89169
- Rekruttering
- Comprehensive Cancer Centers of Nevada
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New Jersey
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East Brunswick, New Jersey, Forenede Stater, 08816
- Rekruttering
- Astera Cancer Care
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New Brunswick, New Jersey, Forenede Stater, 08901
- Rekruttering
- Rutgers Cancer Institute
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Rekruttering
- University of New Mexico Cancer Center
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New York
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Mineola, New York, Forenede Stater, 11501
- Rekruttering
- Perlmutter Cancer Center at NYU Long Island
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New York, New York, Forenede Stater, 10003
- Rekruttering
- Mount Sinai
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New York, New York, Forenede Stater, 10032
- Rekruttering
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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New York, New York, Forenede Stater, 10016
- Rekruttering
- NYU Langone Medical Center NYU Hematology Associates
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New York, New York, Forenede Stater, 10009
- Rekruttering
- Mount Sinai West
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Shirley, New York, Forenede Stater, 11967
- Rekruttering
- New York Cancer and Blood Specialists
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The Bronx, New York, Forenede Stater, 10461
- Rekruttering
- Montefiore Einstein Comprehensive Cancer Center
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Williamsville, New York, Forenede Stater, 14221
- Rekruttering
- University of Buffalo Kaleida Health Cancer Care
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Rekruttering
- University of North Carolina at Chapel Hill
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- Rekruttering
- Gabrail Cancer Center
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Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Taussig Cancer Insititute Cleveland Clinic
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Cleveland, Ohio, Forenede Stater, 44111
- Rekruttering
- Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
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Independence, Ohio, Forenede Stater, 44131
- Rekruttering
- Cleveland Clinic Cancer Center Independence Family Health Center
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Mansfield, Ohio, Forenede Stater, 44906
- Rekruttering
- Cleveland Clinic Cancer Center Mansfield
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Mayfield Heights, Ohio, Forenede Stater, 44124
- Rekruttering
- Cleveland Clinic Cancer Center Hillcrest Hospital
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Sandusky, Ohio, Forenede Stater, 44870
- Rekruttering
- Cleveland Clinic Cancer Centers Sandusky
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Strongsville, Ohio, Forenede Stater, 44136
- Rekruttering
- Cleveland Clinic Cancer Center Strongsville
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Warrensville Heights, Ohio, Forenede Stater, 44122
- Rekruttering
- Cleveland Clinic Cancer Center South Pointe Hospital
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Wooster, Ohio, Forenede Stater, 44691
- Rekruttering
- Wooster Milltown Specialty and Surgery Center
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Oregon
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Bend, Oregon, Forenede Stater, 97701
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- St Charles Medical Center
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Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Rekruttering
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Rekruttering
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Forenede Stater, 15232 1301
- Rekruttering
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- SCRI Oncology Partners
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Texas
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Abilene, Texas, Forenede Stater, 79606
- Rekruttering
- Texas Oncology West Texas
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Dallas, Texas, Forenede Stater, 75246
- Rekruttering
- Texas Oncology DFW
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Dallas, Texas, Forenede Stater, 75390
- Rekruttering
- UT Southwestern
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- MD Anderson Cancer Center
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Round Rock, Texas, Forenede Stater, 78665
- Rekruttering
- Baylor Scott and White Health 1
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San Antonio, Texas, Forenede Stater, 78240
- Rekruttering
- Texas Oncology - San Antonio
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Temple, Texas, Forenede Stater, 76508
- Rekruttering
- Baylor Scott and White Health
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Virginia
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Arlington, Virginia, Forenede Stater, 22201
- Rekruttering
- Virginia Cancer Specialists
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Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Inova Schar Cancer Institute Dept of Fairfax Hospital
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Richmond, Virginia, Forenede Stater, 23249
- Rekruttering
- Richmond VA Medical Center
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Richmond, Virginia, Forenede Stater, 23298
- Rekruttering
- VCU Massey Comprehensive Cancer Center
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Washington
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Edmonds, Washington, Forenede Stater, 98026
- Rekruttering
- Swedish Cancer Institute Edmonds
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Issaquah, Washington, Forenede Stater, 98029
- Rekruttering
- Swedish Cancer Institute Issaquah
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Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Swedish Cancer Institute
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Seattle, Washington, Forenede Stater, 98109
- Rekruttering
- Fred Hutchinson Cancer Research Center
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53705
- Rekruttering
- William S. Middleton Memorial VA
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Avignon, Frankrig, 84918
- Rekruttering
- Institut Sainte Catherine
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Lille, Frankrig, 59000
- Rekruttering
- Hopital Claude Huriez
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Lyon, Frankrig, 69008
- Rekruttering
- Hopital Prive Jean Mermoz
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Montpellier, Frankrig, 34298
- Rekruttering
- Institut du Cancer de Montpellier
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Nantes, Frankrig, 44000
- Rekruttering
- CHU Nantes
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Paris, Frankrig, 75571
- Rekruttering
- Hopital Saint Antoine
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Pessac, Frankrig, 33604
- Rekruttering
- Hopital Haut Leveque
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Poitiers, Frankrig, 86000
- Rekruttering
- CHU De Poitiers
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Villejuif, Frankrig, 94805
- Rekruttering
- Gustave Roussy
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Amersfoort, Holland, 3813 TZ
- Rekruttering
- Meander Medisch Centrum
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Amsterdam, Holland, 1066 CX
- Rekruttering
- Antoni van Leeuwenhoek
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Nijmegen, Holland, 6525 GA
- Rekruttering
- Radboud University Medical Center
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Rotterdam, Holland, 3015 GD
- Rekruttering
- Erasmus MC
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Tilburg, Holland, 5022 GC
- Rekruttering
- Elisabeth-TweeSteden Ziekenhuis
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Utrecht, Holland, 3584 CX
- Rekruttering
- UMC Utrecht
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Delhi, Indien, 110085
- Rekruttering
- Rajiv Gandhi Cancer Institute and Research Centre
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Kolkata, Indien, 700053
- Rekruttering
- B P Poddar Hospital and Medical research Limited
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Mumbai, Indien, 400012
- Rekruttering
- Tata Memorial Hospital
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Pune, Indien, 411004
- Rekruttering
- Deenanath Mangeshkar Hospital and Research Centre
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Varanasi, Indien, 221005
- Rekruttering
- Mahamana Pandit Madan Mohan Malviya Cancer Centre
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Beer Yaakov, Israel, 70300
- Rekruttering
- Yitzhak Shamir Medical Center
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Haifa, Israel, 3109601
- Rekruttering
- Rambam Medical Center
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Jerusalem, Israel, 9112001
- Rekruttering
- Hadassah University Hospita Ein Kerem
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Petah Tikva, Israel, 4941492
- Rekruttering
- Rabin Medical Center
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Ramat Gan, Israel, 52621
- Afsluttet
- Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Rekruttering
- Tel Aviv Sourasky Medical Center
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Tel Aviv, Israel, 69710
- Rekruttering
- Assuta MC
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Meldola, Italien, 47014
- Rekruttering
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, Italien, 20133
- Rekruttering
- Istituto Dei Tumori Di Milano
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Padova, Italien, 35128
- Rekruttering
- Istituto Oncologico Veneto - IRCCS
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Pisa, Italien, 56126
- Rekruttering
- Azienda Ospedaliero Universitaria Pisana
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Rozzano, Italien, 20089
- Rekruttering
- Istituto Clinico Humanitas
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Chiba, Japan, 260 0801
- Rekruttering
- Chiba Cancer Center
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Chūōku, Japan, 104 0045
- Rekruttering
- National Cancer Center Hospital
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Kashiwa, Japan, 277 8577
- Rekruttering
- National Cancer Center Hospital East
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Nagoya, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center
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Osaka, Japan, 541 8567
- Rekruttering
- Osaka International Cancer Institute
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Osaka, Japan, 540 0006
- Rekruttering
- National Hospital Organization Osaka National Hospital
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Shizuoka, Japan, 411 8777
- Rekruttering
- Shizuoka Cancer Center
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Suita, Japan, 565 0871
- Rekruttering
- The University of Osaka Hospital
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Tokyo, Japan, 135 8550
- Rekruttering
- The Cancer Institute Hospital of JFCR
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Beijing, Kina, 100191
- Rekruttering
- Peking University Third Hospital
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Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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Beijing, Kina, 100034
- Rekruttering
- Peking University First Hospital
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Beijing, Kina, 100050
- Rekruttering
- Beijing Friendship Hospital Capital Medical University
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Changchun, Kina, 130021
- Rekruttering
- The First Bethune Hospital of Jilin University
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Changsha, Kina, 410013
- Rekruttering
- Hunan Cancer hospital
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Guangzhou, Kina, 510655
- Rekruttering
- The Sixth Affiliated Hospital Sun Yat sen University
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Guangzhou, Kina, 519041
- Rekruttering
- Guangdong Provincial People's Hospital
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Guangzhou, Kina, 510062
- Rekruttering
- Sun Yat Sen University Cancer Center
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Hangzhou, Kina, 310009
- Rekruttering
- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Hangzhou, Kina, 310022
- Rekruttering
- Zhejiang Cancer Hospital
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Hangzhou, Kina, 310003
- Rekruttering
- The First Affiliated Hospital Zhejiang University College of Medicine
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Harbin, Kina, 150081
- Rekruttering
- Harbin medical university cancer hospital
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Huizhou, Kina, 516001
- Rekruttering
- Huizhou Central People's Hospital
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Nanchang, Kina, 330006
- Rekruttering
- The First Affiliated Hospital of NanChang University
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Shanghai, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center
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Shenyang, Kina, 110042
- Rekruttering
- Liaoning Cancer Hospital and Institute
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Shenzhen, Kina, 518036
- Rekruttering
- Peking University Shenzhen Hospital
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Sichuan, Kina, 610044
- Rekruttering
- West China Hospital of Sichuan University
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Taiyuan, Kina, 030001
- Rekruttering
- First Hospital of Shanxi Medical University
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Tianjin, Kina, 300060
- Rekruttering
- Tianjin Medical University Cancer Institute and Hospital
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Wuhan, Kina, 430079
- Rekruttering
- Hubei Cancer Hospital
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Cheras, Malaysia, 56000
- Rekruttering
- Hospital Canselor Tuanku Muhriz UKM
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George Town, Malaysia, 10450
- Rekruttering
- Hospital Pulau Pinang
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Ipoh, Malaysia, 30450
- Rekruttering
- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, Malaysia, 59100
- Rekruttering
- University Malaya Medical Centre
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Kuala Lumpur, Malaysia, 50586
- Rekruttering
- Hospital Kuala Lumpur
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Kuching, Malaysia, 93586
- Rekruttering
- Hospital Umum Sarawak
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Putrajaya, Malaysia, 62250
- Rekruttering
- National Cancer Institute
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Bialystok, Polen, 15 027
- Rekruttering
- Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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Biała Podlaska, Polen, 21 500
- Afsluttet
- Wojewodzki Szpital Specjalistyczny
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Brzozów, Polen, 36 200
- Rekruttering
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
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Gdansk, Polen, 80 214
- Rekruttering
- Uniwersyteckie Centrum Kliniczne
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Gliwice, Polen, 44 100
- Rekruttering
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
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Lodz, Polen, 93 339
- Afsluttet
- Instytut Centrum Zdrowia Matki Polki
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Olsztyn, Polen, 10 228
- Rekruttering
- Szpital Kliniczny MSWiA z WMCO
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Opole, Polen, 45 061
- Rekruttering
- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
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Warsaw, Polen, 02 781
- Rekruttering
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Barrio Monacillos, Puerto Rico, 00935
- Rekruttering
- Pan American Center for Oncology Trials LLC
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Barcelona, Spanien, 08041
- Rekruttering
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Spanien, 08035
- Rekruttering
- Hosp Univ Vall D Hebron
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Madrid, Spanien, 28034
- Rekruttering
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spanien, 28041
- Rekruttering
- Hosp. Univ. 12 de Octubre
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Madrid, Spanien, 28007
- Rekruttering
- Hosp. Gral. Univ. Gregorio Maranon
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Pamplona, Spanien, 31008
- Rekruttering
- Clinica Univ. de Navarra
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Seville, Spanien, 41013
- Rekruttering
- Hosp. Virgen Del Rocio
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Valencia, Spanien, 46010
- Rekruttering
- Hosp. Clinico Univ. de Valencia
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-
-
-
-
Gothenburg, Sverige, 413 45
- Afsluttet
- Sahlgrenska University Hospital
-
Lund, Sverige, 222 42
- Rekruttering
- Skanes universitetssjukhus
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Stockholm, Sverige, 171 76
- Rekruttering
- Karolinska Universitetssjukhuset
-
Stockholm, Sverige, 118 83
- Rekruttering
- Sodersjukhuset
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Uppsala, Sverige, SE 751 85
- Rekruttering
- Uppsala University
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-
-
-
-
Daegu, Sydkorea, 41404
- Rekruttering
- Kyungpook National University Chilgok Hospital
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Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
-
Seoul, Sydkorea, 03080
- Rekruttering
- Seoul National University Hospital
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Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Seoul, Sydkorea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System
-
Seoul, Sydkorea, 06591
- Rekruttering
- The Catholic University of Korea Seoul St Marys Hospital
-
-
-
-
-
Kaohsiung City, Taiwan, 83301
- Rekruttering
- Kaohsiung Chang Gung Memorial Hospital
-
Kaohsiung City, Taiwan, 80756
- Rekruttering
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Tainan, Taiwan, 704
- Rekruttering
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 10043
- Rekruttering
- National Taiwan University Hospital
-
Taoyuan, Taiwan, 333
- Rekruttering
- Linkou Chang Gung Memorial Hospital
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-
-
-
-
Adana, Tyrkiet (Türkiye), 01060
- Rekruttering
- Adana City Hospital
-
Ankara, Tyrkiet (Türkiye), 06800
- Rekruttering
- Ankara Bilkent Sehir Hastanesi
-
Ankara, Tyrkiet (Türkiye), 06010
- Rekruttering
- Gulhane Egitim ve Arastirma Hastanesi
-
Ankara, Tyrkiet (Türkiye), 06200
- Rekruttering
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
Ankara, Tyrkiet (Türkiye), 06560
- Rekruttering
- Gazi Universitesi Hastanesi
-
Istanbul, Tyrkiet (Türkiye), 34147
- Rekruttering
- Bakirkoy Training and Research Hospital
-
Istanbul, Tyrkiet (Türkiye), 34899
- Rekruttering
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
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Konya, Tyrkiet (Türkiye), 42090
- Rekruttering
- Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
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Sakarya, Tyrkiet (Türkiye), 54290
- Rekruttering
- Sakarya University Training and Research Hospital
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-
-
-
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Berlin, Tyskland, 13353
- Rekruttering
- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
-
Dresden, Tyskland, 01307
- Rekruttering
- Universitaetsklinikum Carl Gustav Carus TU Dresden
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Essen, Tyskland, 45147
- Rekruttering
- Essen University Hospital
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Frankfurt am Main, Tyskland, 60488
- Rekruttering
- Krankenhaus NorthWest
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Freiburg im Breisgau, Tyskland, 79110
- Rekruttering
- Praxis fur interdisziplinare Onkologie & Hamatologie GbR
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Hamburg, Tyskland, 22763
- Rekruttering
- Asklepios Klinik Altona
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Heidelberg, Tyskland, 69120
- Rekruttering
- National Center for Tumor Diseases NCT
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Mainz, Tyskland, 55131
- Rekruttering
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Munich, Tyskland, 81377
- Rekruttering
- Klinikum der Universitaet Muenchen
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Ulm, Tyskland, 89081
- Rekruttering
- Universitatsklinikum Ulm
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-
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Budapest, Ungarn, 1082
- Rekruttering
- Semmelweis Egyetem
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Eger, Ungarn, 3300
- Rekruttering
- Markhot Ferenc Oktatokorhaz es Rendelointezet
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Pécs, Ungarn, 7624
- Afsluttet
- Pecsi Tudomanyegyetem
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Szeged, Ungarn, 6720
- Rekruttering
- Szegedi Tudomanyegyetem
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
- Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available)
- Must agree to the submission of fresh tumor tissue
- Have measurable disease according to RECIST v1.1
- Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (>) 12 months prior to CRC recurrence/metastases
- Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
Exclusion Criteria:
- Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
- Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI
- Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor
- Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)
Studieplan
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 / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Arm A: Amivantamab in Combination With Chemotherapy
Participants will receive amivantamab in combination with chemotherapy (mFOLFOX6 [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin] or FOLFIRI [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met. |
Amivantamab will be administered.
Andre navne:
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Oxaliplatin will be administered as chemotherapy regimen. Irinotecan hydrochloride will be administered as chemotherapy regimen. |
|
Aktiv komparator: Arm B: Cetuximab in Combination With Chemotherapy
Participants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met. |
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Oxaliplatin will be administered as chemotherapy regimen. Irinotecan hydrochloride will be administered as chemotherapy regimen. Cetuximab will be administered.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Tidsramme: Up to 4 years and 2 months
|
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v) 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date. |
Up to 4 years and 2 months
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to 7 Years 3 Months
|
OS is defined as the time from the date of randomization to the date of participant's death due to any cause. Any participant not known to have died at the time of analysis will be censored based on the last recorded date on which the participant was known to be alive. |
Up to 7 Years 3 Months
|
|
Objective Response Rate (ORR) as Assessed by BICR
Tidsramme: Up to 7 Years 3 Months
|
ORR is defined as the proportion of randomized participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria. BOR is defined as best response recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent systemic anti cancer therapy or date of curative-intent procedure, whichever occurs first. |
Up to 7 Years 3 Months
|
|
Objective Response Rate (ORR) as Assessed by Investigator
Tidsramme: Up to 7 Years 3 Months
|
ORR is defined as the percentage of randomized participants achieving complete CR or PR, as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Progression Free Survival (PFS) as Assessed by Investigator
Tidsramme: Up to 7 Years 3 Months
|
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by the investigator. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable disease assessment date. |
Up to 7 Years 3 Months
|
|
Duration of Response (DOR) as Assessed by BICR
Tidsramme: Up to 7 Years 3 Months
|
DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by BICR using RECIST v1.1 criteria. |
Up to 7 Years 3 Months
|
|
Duration of Response (DOR) as Assessed Investigator
Tidsramme: Up to 7 Years 3 Months
|
DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Time to Response (TTR) as Assessed by BICR
Tidsramme: Up to 7 Years 3 Months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by BICR. |
Up to 7 Years 3 Months
|
|
Time to Response as Assessed by Investigator
Tidsramme: Up to 7 Years 3 Months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by investigator. |
Up to 7 Years 3 Months
|
|
Progression-free Survival After Subsequent Therapy (PFS2)
Tidsramme: Up to 7 Years 3 Months
|
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first. |
Up to 7 Years 3 Months
|
|
Disease Control Rate (DCR) as Assessed by BICR
Tidsramme: Up to 7 Years 3 Months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by BICR using RECIST v1.1 criteria. |
Up to 7 Years 3 Months
|
|
Disease Control Rate (DCR) as Assessed by Investigator
Tidsramme: Up to 7 Years 3 Months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Time to Treatment Failure
Tidsramme: Up to 7 Years 3 Months
|
Time to treatment failure is defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity, or initiation of new anticancer therapy. |
Up to 7 Years 3 Months
|
|
Curative Resection (R0) Rate
Tidsramme: Up to 7 Years 3 Months
|
Curative resection (R0) rate is defined as the proportion of participants from the analysis set who underwent curative-intent surgery, where the residual tumor classification was R0. |
Up to 7 Years 3 Months
|
|
Number of Participants with Adverse Events (AEs) by Severity
Tidsramme: Up to 7 Years 3 Months
|
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. AE severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) v5.0. by using the standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE. |
Up to 7 Years 3 Months
|
|
Number of Participants with Abnormalities in Laboratory Values
Tidsramme: Up to 7 Years 3 Months
|
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported. |
Up to 7 Years 3 Months
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Tidsramme: From Baseline up to 7 Years 3 Months
|
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms. |
From Baseline up to 7 Years 3 Months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
Tidsramme: Up to 7 Years 3 Months
|
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptom. |
Up to 7 Years 3 Months
|
|
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC-QLQ-C29) Score
Tidsramme: From Baseline up to 7 Years 3 Months
|
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. |
From Baseline up to 7 Years 3 Months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29
Tidsramme: Up to 7 Years 3 Months
|
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. |
Up to 7 Years 3 Months
|
|
Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score
Tidsramme: Up to 7 Years 3 Months
|
The EORTC item 168 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "not at all" to 4 "very much." Higher scores indicate severe side effects. |
Up to 7 Years 3 Months
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Tarmsygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Tyktarmssygdomme
- Kolorektale neoplasmer
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Camptothecin
- Alkaloider
- Enzymer og coenzymer
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Koordinationskomplekser
- Pyrimidiner
- Formyltetrahydrofolater
- Tetrahydrofolater
- Folinsyre
- Pterins
- Pteridiner
- Uracil
- Pyrimidinoner
- Coenzymer
- Oxaliplatin
- Irinotecan
- Cetuximab
- Fluorouracil
- Leucovorin
- Levoleucovorin
- Amivantamab
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 61186372COR3001
- 2024-513852-13-00 (Registry Identifier: EUCT number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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