Eine Studie zu Amivantamab und FOLFIRI im Vergleich zu Cetuximab/Bevacizumab und FOLFIRI bei Teilnehmern mit KRAS/NRAS- und BRAF-Wildtyp-Darmkrebs, die zuvor eine Chemotherapie erhalten hatten (OrigAMI-3)
Eine randomisierte, offene Phase-3-Studie zu Amivantamab + FOLFIRI im Vergleich zu Cetuximab/Bevacizumab + FOLFIRI bei Teilnehmern mit rezidivierendem, inoperablem oder metastasiertem Darmkrebs vom Wildtyp KRAS/NRAS und BRAF, die zuvor eine Chemotherapie erhalten haben
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Erweiterter Zugriff
Kontakte und Standorte
Studienkontakt
- Name: Study Contact
- Telefonnummer: 844-434-4210
- E-Mail: Participate-In-This-Study1@its.jnj.com
Studienorte
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Concord, Australien, 2139
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- Concord Hospital
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Heidelberg, Australien, 3084
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- Warringal Private Hospital
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South Woodville, Australien, 5011
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- Queen Elizabeth Hospital
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St Albans, Australien, 3021
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- Western Health Sunshine Hospital
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Anderlecht, Belgien, 1070
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- Institut Jules Bordet
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Edegem, Belgien, 2650
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- UZ Antwerpen
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Ghent, Belgien, 9000
- Abgeschlossen
- AZ Maria Middelares
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Haine Saint Paul La Louviere, Belgien, 7100
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- Jolimont
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Kortrijk, Belgien, 8500
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- Az Groeninge
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Leuven, Belgien, 3000
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- Universitair Ziekenhuis Leuven
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Liège, Belgien, 4000
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- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
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Barretos, Brasilien, 14780 070
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- Fundacao Pio XII
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Caxias do Sul, Brasilien, 95070 560
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- Fundacao Universidade de Caxias do Sul
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Jaú, Brasilien, 17210 080
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- Fundacao Doutor Amaral Carvalho
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Porto Alegre, Brasilien, 91350 200
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- Hospital Nossa Senhora da Conceicao S A
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Salvador, Brasilien, 40050 410
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- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
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São José do Rio Preto, Brasilien, 15090-000
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- Funfarme Sjrp
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São Paulo, Brasilien, 01246 000
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- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brasilien, 01509 900
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- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasilien, 05651 900
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- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Vitória, Brasilien, 29043 260
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- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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Beijing, China, 100142
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- Beijing Cancer Hospital
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Beijing, China, 100034
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- Peking University First Hospital
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Beijing, China, 100050
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- Beijing Friendship Hospital Capital Medical University
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Changchun, China, 130021
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- The First Bethune Hospital of Jilin University
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Changsha, China, 410013
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- Hunan Cancer hospital
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Chengdu, China, 610041
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- West China Hospital of Sichuan University
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Ganzhou, China, 341000
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- Ganzhou Cancer Hospital
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Guangzhou, China, 510655
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- The Sixth Affiliated Hospital Sun Yat sen University
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Guangzhou, China, 519041
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- Guangdong Provincial People's Hospital
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Guangzhou, China, 100142
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- Sun Yat Sen University Cancer Center
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Hangzhou, China, 310022
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- Zhejiang Cancer Hospital
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Hangzhou, China, 310009
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- The Second Affiliated Hospital of Zhejiang University
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Harbin, China, 150081
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- Harbin medical university cancer hospital
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Huizhou, China, 516001
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- Huizhou Central People's Hospital
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Lanzhou, China, 730050
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- Gansu Provincial Cancer Hospital
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Nanchang, China, 330006
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- The First Affiliated Hospital of NanChang University
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Shanghai, China, 200032
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- Fudan University Shanghai Cancer Center
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Shenyang, China, 110042
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- Liaoning Cancer Hospital and Institute
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Tianjin, China, 300060
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- Tianjin Medical University Cancer Institute and Hospital
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Wuhan, China, 430079
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- Hubei Cancer Hospital
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Berlin, Deutschland, 13353
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- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
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Frankfurt am Main, Deutschland, 60488
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- Krankenhaus NorthWest
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Heidelberg, Deutschland, 69120
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- National Center for Tumor Diseases NCT
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Mainz, Deutschland, 55131
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- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Munich, Deutschland, 81377
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- Klinikum der Universitaet Muenchen
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Avignon, Frankreich, 84918
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- Institut Sainte Catherine
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Pessac, Frankreich, 33604
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- Hopital Haut Leveque
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Poitiers, Frankreich, 86000
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- CHU De Poitiers
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Hong Kong, Hongkong
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- Queen Mary Hospital
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Shatin, Hongkong
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- Prince Of Wales Hospital
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Delhi, Indien, 110085
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- Rajiv Gandhi Cancer Institute and Research Centre
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Hyderabad, Indien, 500032
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- Asian Institute Of Gastroenterology
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Kolkata, Indien, 700053
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- B P Poddar Hospital and Medical research Limited
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Mumbai, Indien, 400012
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- Tata Memorial Hospital
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New Delhi, Indien, 110029
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- Safdarjung Hospital
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Pune, Indien, 411004
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- Deenanath Mangeshkar Hospital and Research Centre
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Varanasi, Indien, 221005
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- Mahamana Pandit Madan Mohan Malviya Cancer Centre
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Vellore, Indien, 632004
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- Christian medical
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Beer Yaakov, Israel, 70300
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- Yitzhak Shamir Medical Center
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Haifa, Israel, 3109601
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- Rambam Medical Center
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Jerusalem, Israel, 9112001
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- Hadassah Medical Center
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Petah Tikva, Israel, 4941492
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- Rabin Medical Center
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Ramat Gan, Israel, 52621
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- Sheba Medical Center
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Tel Aviv, Israel, 6423906
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- Tel Aviv Sourasky Medical Center
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Tel Aviv, Israel, 69710
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- Assuta MC
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Catania, Italien, 95122
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- ARNAS Garibaldi P O Nesima
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Florence, Italien, 50134
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- Careggi University Hospital
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Milan, Italien, 20133
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- Istituto Dei Tumori Di Milano
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Novara, Italien, 28100
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- Fondazione del Piemonte per I Oncologia IRCC Candiolo
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Padova, Italien, 35128
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- Istituto Oncologico Veneto - IRCCS
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Pisa, Italien, 56126
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- Azienda Ospedaliero Universitaria Pisana
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Rozzano, Italien, 20089
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- Istituto Clinico Humanitas
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Udine, Italien, 33100
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- Azienda Sanitaria Universitaria Friuli Centrale ASU FC
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Chiba, Japan, 260 0801
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- Chiba Cancer Center
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Chūōku, Japan, 104 0045
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- National Cancer Center Hospital
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Kashiwa, Japan, 277 8577
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- National Cancer Center Hospital East
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Nagoya, Japan, 464-8681
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- Aichi Cancer Center
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Osaka, Japan, 541 8567
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- Osaka International Cancer Institute
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Osaka, Japan, 540 0006
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- National Hospital Organization Osaka National Hospital
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Sakai, Japan, 590 0197
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- Kindai University Hospital
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Shizuoka, Japan, 411 8777
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- Shizuoka Cancer Center
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Suita, Japan, 565 0871
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- The University of Osaka Hospital
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Tokyo, Japan, 135 8550
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- The Cancer Institute Hospital of JFCR
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George Town, Malaysia, 10450
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- Hospital Pulau Pinang
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Ipoh, Malaysia, 30450
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- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, Malaysia, 59100
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- University Malaya Medical Centre
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Kuala Lumpur, Malaysia, 50586
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- Hospital Kuala Lumpur
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Kuching, Malaysia, 93586
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- Hospital Umum Sarawak
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Putrajaya, Malaysia, 62250
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- Institut Kanser Negara Clinical Research Center
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Chihuahua City, Mexiko, 31217
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- Centro Oncologico de Chihuahua
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Guadalajara, Mexiko, 44680
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- Actualidad Basada En La Investigacion Del Cancer
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Mexico City, Mexiko, 14080
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- Instituto Nacional de Cancerologia
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Mexico City, Mexiko, 06760
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- Centro Oncologico Personalizado Cope S De R L De C V
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Monterrey, Mexiko, 64460
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- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Puebla City, Mexiko, 72530
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- Oncocenter
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Querétaro, Mexiko, 76000
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- Cuidados Oncologicos
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Querétaro, Mexiko, 76230
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- Health Pharma Queretaro SA de CV
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Tijuana, Mexiko, 22010
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- COI Centro Oncologico Internacional Tijuana
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Amersfoort, Niederlande, 3813 TZ
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- Meander Medisch Centrum
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Amsterdam, Niederlande, 1066 CX
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- Antoni van Leeuwenhoek
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Nijmegen, Niederlande, 6525 GA
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- Radboud University Medical Center
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Rotterdam, Niederlande, 3015 GD
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- Erasmus MC
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Tilburg, Niederlande, 5042 AD
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- ETZ TweeSteden
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Bialystok, Polen, 15 027
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- Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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Biała Podlaska, Polen, 21 500
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- Wojewodzki Szpital Specjalistyczny
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Brzozów, Polen, 36 200
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- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
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Gdansk, Polen, 80 214
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- Uniwersyteckie Centrum Kliniczne
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Gliwice, Polen, 44 100
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- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
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Lodz, Polen, 93 339
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- Instytut Centrum Zdrowia Matki Polki
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Olsztyn, Polen, 10 228
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- Szpital Kliniczny MSWiA z WMCO
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Opole, Polen, 45 061
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- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
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Warsaw, Polen, 02 034
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- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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San Juan, Puerto Rico, 00935
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- Pan American Center for Oncology Trials LLC
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Brasov, Rumänien, 500091
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- Centrul Medical Unirea SRL
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Bucharest, Rumänien, 013812
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- Spitalul Memorial Baneasa
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Bucharest, Rumänien, 014142
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- Ponderas Academic Hospital
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Bucharest, Rumänien, 077190
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- Neolife Medical Center Bucharest
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Cluj-Napoca, Rumänien, 400015
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- Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca
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Craiova, Rumänien, 200542
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- Clinica de Oncologie Sf Nectarie
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Iași, Rumänien, 700483
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- Institutul Regional de Oncologie Iasi
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Oradea, Rumänien, 410469
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- Pelican Impex SRL
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Gothenburg, Schweden, 413 45
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- Sahlgrenska Universitetssjukhuset
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Lund, Schweden, 222 42
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- Skanes universitetssjukhus
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Stockholm, Schweden, 171 76
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- Karolinska Universitetssjukhuset
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Stockholm, Schweden, 118 83
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- Sodersjukhuset
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Uppsala, Schweden, SE 751 85
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- Uppsala University
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Badajoz, Spanien, 06006
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- Hosp. Univ. de Badajoz
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Barcelona, Spanien, 08028
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- Hosp. Univ. Quiron Dexeus
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Barcelona, Spanien, 08003
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- Hosp. Del Mar
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Barcelona, Spanien, 08041
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- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Spanien, 08035
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- Hosp Univ Vall D Hebron
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Madrid, Spanien, 28034
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- Hosp. Univ. Ramon Y Cajal
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Madrid, Spanien, 28041
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- Hosp. Univ. 12 de Octubre
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Madrid, Spanien, 28007
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- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Spanien, 28040
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- Hosp Univ Fund Jimenez Diaz
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Madrid, Spanien, 28002
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- Hosp San Francisco de Asis
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Málaga, Spanien, 29010
- Rekrutierung
- Hosp Regional Univ de Malaga
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Pamplona, Spanien, 31008
- Rekrutierung
- Clinica Univ. de Navarra
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Seville, Spanien, 41013
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- Hosp. Virgen Del Rocio
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Valencia, Spanien, 46010
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- Hosp. Clinico Univ. de Valencia
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Daegu, Südkorea, 41404
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- Kyungpook National University Chilgok Hospital
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Seoul, Südkorea, 05505
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- Asan Medical Center
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Seoul, Südkorea, 03080
- Rekrutierung
- Seoul National University Hospital
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Seoul, Südkorea, 06351
- Rekrutierung
- Samsung Medical Center
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Seoul, Südkorea, 02841
- Rekrutierung
- Korea University Anam Hospital
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Seoul, Südkorea, 03722
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- Severance Hospital Yonsei University Health System
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Seoul, Südkorea, 06591
- Rekrutierung
- The Catholic University of Korea Seoul St Mary s Hospital
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Kaohsiung City, Taiwan, 833
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- Chang Gung Memorial Hospital
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Kaohsiung City, Taiwan, 80756
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- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taichung, Taiwan, 40705
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- Taichung Veterans General Hospital
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Tainan, Taiwan, 704
- Rekrutierung
- National Cheng Kung University Hospital
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Taipei, Taiwan, 112
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- Taipei Veterans General Hospital
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Taipei, Taiwan, 10043
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- National Taiwan University Hospital
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Taoyuan, Taiwan, 333
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- Linkou Chang Gung Memorial Hospital
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Bangkok, Thailand, 10700
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- Siriraj Hospital
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Bangkok, Thailand, 10400
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- Ramathibodi Hospital
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Chiang Mai, Thailand, 50200
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- Chiang Mai University
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Songkhla, Thailand, 90110
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- Songklanagarind hospital
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Adana, Türkei (türkiye), 01060
- Rekrutierung
- Adana City Hospital
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Ankara, Türkei (türkiye), 06800
- Rekrutierung
- Ankara Bilkent Sehir Hastanesi
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Ankara, Türkei (türkiye), 06010
- Rekrutierung
- Gulhane Egitim ve Arastirma Hastanesi
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Ankara, Türkei (türkiye), 06200
- Rekrutierung
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
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Ankara, Türkei (türkiye), 06560
- Rekrutierung
- Gazi Universitesi Hastanesi
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Antalya, Türkei (türkiye), 07025
- Rekrutierung
- Memorial Antalya Hospital
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Edirne, Türkei (türkiye), 22030
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- Trakya University Medical Faculty
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Istanbul, Türkei (türkiye), 34147
- Rekrutierung
- Bakirkoy Training and Research Hospital
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Istanbul, Türkei (türkiye), 34899
- Rekrutierung
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
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Konya, Türkei (türkiye), 42090
- Rekrutierung
- Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
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Sakarya, Türkei (türkiye), 54290
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- Sakarya University Training and Research Hospital
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Eger, Ungarn, 3300
- Abgeschlossen
- Markhot Ferenc Oktatokorhaz es Rendelointezet
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Pécs, Ungarn, 7624
- Abgeschlossen
- Pecsi Tudomanyegyetem
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Szeged, Ungarn, 6720
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- Szegedi Tudomanyegyetem
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Arizona
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Chandler, Arizona, Vereinigte Staaten, 85224
- Rekrutierung
- Ironwood Cancer and Research Center
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Gilbert, Arizona, Vereinigte Staaten, 85234
- Rekrutierung
- Banner MD Anderson Cancer Center
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Prescott, Arizona, Vereinigte Staaten, 86301
- Abgeschlossen
- Arizona Oncology Associates PC NAHOA
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Arkansas
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Jonesboro, Arkansas, Vereinigte Staaten, 72401
- Rekrutierung
- St. Bernard's Medical Center
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Springdale, Arkansas, Vereinigte Staaten, 72762
- Rekrutierung
- Highlands Oncology Group
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California
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Bakersfield, California, Vereinigte Staaten, 93309
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- CBCC Global Research
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Glendale, California, Vereinigte Staaten, 91204
- Rekrutierung
- Los Angeles Cancer Network
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Los Alamitos, California, Vereinigte Staaten, 90720
- Rekrutierung
- Cancer and Blood Specialty Clinic
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Los Angeles, California, Vereinigte Staaten, 90033
- Rekrutierung
- USC Norris Comprehensive Cancer Center
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Santa Monica, California, Vereinigte Staaten, 90404
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- UCLA
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Santa Rosa, California, Vereinigte Staaten, 95403
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- Providence Medical Foundation
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Torrance, California, Vereinigte Staaten, 90505
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- Torrance Memorial Physicians Network
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
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- University of Colorado Denver Anschultz Medical Campus
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Denver, Colorado, Vereinigte Staaten, 80218
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- Rocky Mountain Cancer Centers
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Connecticut
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Norwich, Connecticut, Vereinigte Staaten, 06360
- Abgeschlossen
- Eastern Connecticut Hematology & Oncology Assoc.
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Florida
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Fort Myers, Florida, Vereinigte Staaten, 33901
- Rekrutierung
- Florida Cancer Specialists South
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Miami Beach, Florida, Vereinigte Staaten, 33140
- Abgeschlossen
- Mount Sinai Medical Center Campus
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Orlando, Florida, Vereinigte Staaten, 32804
- Rekrutierung
- AdventHealth Cancer Institute
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St. Petersburg, Florida, Vereinigte Staaten, 33701-4553
- Rekrutierung
- Florida Cancer Specialists North Region
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West Palm Beach, Florida, Vereinigte Staaten, 33401-3406
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- Florida Cancer Specialists East
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Georgia
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Athens, Georgia, Vereinigte Staaten, 30607
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- University Cancer And Blood Center LLC
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Atlanta, Georgia, Vereinigte Staaten, 30303
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- Grady Memorial Hospital
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Atlanta, Georgia, Vereinigte Staaten, 30318
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- Piedmont Cancer Institute
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Atlanta, Georgia, Vereinigte Staaten, 30322
- Rekrutierung
- Winship Cancer Institute Emory University
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Illinois
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Arlington Heights, Illinois, Vereinigte Staaten, 60005
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- Illinois Cancer Specialists
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Peoria, Illinois, Vereinigte Staaten, 61615
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- Illinois CancerCare
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46237
- Rekrutierung
- Franciscan Health
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Iowa
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Iowa City, Iowa, Vereinigte Staaten, 52242
- Rekrutierung
- University of Iowa Hospitals and Clinics
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Waukee, Iowa, Vereinigte Staaten, 50263
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- Mission Cancer Blood
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Kansas
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Wichita, Kansas, Vereinigte Staaten, 67214
- Rekrutierung
- Cancer Center of Kansas
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Louisiana
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Baton Rouge, Louisiana, Vereinigte Staaten, 70809
- Rekrutierung
- Mary Bird Perkins Cancer Center
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21237
- Rekrutierung
- MedStar Franklin Square Medical Center
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Frederick, Maryland, Vereinigte Staaten, 21702
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- Frederick Health Hospital - James M Stockman Cancer Institute
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- Rekrutierung
- University of Michigan Rogel Cancer Center
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Detroit, Michigan, Vereinigte Staaten, 48202
- Rekrutierung
- Henry Ford Hospital
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Rekrutierung
- Cancer And Hematology Centers of Western Michigan PC
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Mississippi
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Hattiesburg, Mississippi, Vereinigte Staaten, 39401
- Rekrutierung
- Hattiesburg Clinic
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63110
- Rekrutierung
- Washington University School Of Medicine
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68130
- Rekrutierung
- Nebraska Cancer Specialists
-
-
New Jersey
-
East Brunswick, New Jersey, Vereinigte Staaten, 08816
- Rekrutierung
- Astera Cancer Care
-
-
New York
-
Mineola, New York, Vereinigte Staaten, 11501
- Rekrutierung
- Perlmutter Cancer Center at NYU Long Island
-
New York, New York, Vereinigte Staaten, 10016
- Rekrutierung
- NYU Langone Medical Center NYU Hematology Associates
-
Shirley, New York, Vereinigte Staaten, 11967
- Rekrutierung
- New York Cancer and Blood Specialists
-
The Bronx, New York, Vereinigte Staaten, 10461
- Rekrutierung
- Montefiore Einstein Comprehensive Cancer Center
-
Williamsville, New York, Vereinigte Staaten, 14221
- Rekrutierung
- University of Buffalo Kaleida Health Cancer Care
-
-
Ohio
-
Canton, Ohio, Vereinigte Staaten, 44718
- Rekrutierung
- Gabrail Cancer Center
-
Cleveland, Ohio, Vereinigte Staaten, 44106
- Rekrutierung
- University Hospital of Cleveland
-
-
Oregon
-
Portland, Oregon, Vereinigte Staaten, 97239
- Rekrutierung
- Oregon Health And Science University
-
-
Pennsylvania
-
Penn Wynne, Pennsylvania, Vereinigte Staaten, 19096
- Rekrutierung
- Alliance Cancer Specialists at Main Line
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19111
- Rekrutierung
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
- Rekrutierung
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232 1301
- Rekrutierung
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
-
-
Tennessee
-
Chattanooga, Tennessee, Vereinigte Staaten, 37404
- Rekrutierung
- Tennessee Oncology Chattanooga
-
Nashville, Tennessee, Vereinigte Staaten, 37232
- Rekrutierung
- Vanderbilt University Medical Center
-
Nashville, Tennessee, Vereinigte Staaten, 37203
- Rekrutierung
- Tennessee Oncology
-
Nashville, Tennessee, Vereinigte Staaten, 37203
- Rekrutierung
- SCRI Oncology Partners
-
-
Texas
-
Abilene, Texas, Vereinigte Staaten, 79606
- Rekrutierung
- Texas Oncology West Texas
-
Dallas, Texas, Vereinigte Staaten, 75390
- Rekrutierung
- UT Southwestern Medical Center
-
Dallas, Texas, Vereinigte Staaten, 75235
- Rekrutierung
- Parkland Health and Hospital System
-
Dallas, Texas, Vereinigte Staaten, 75246
- Rekrutierung
- Texas Oncology DFW
-
Houston, Texas, Vereinigte Staaten, 77030
- Rekrutierung
- MD Anderson Cancer Center
-
Round Rock, Texas, Vereinigte Staaten, 77845
- Rekrutierung
- Baylor Scott & White Medical Center
-
San Antonio, Texas, Vereinigte Staaten, 78240
- Rekrutierung
- Texas Oncology - San Antonio
-
Temple, Texas, Vereinigte Staaten, 76508
- Rekrutierung
- Scott And White Memorial Hospital
-
Tyler, Texas, Vereinigte Staaten, 75701
- Rekrutierung
- UT Health East Texas HOPE Cancer Center
-
-
Virginia
-
Arlington, Virginia, Vereinigte Staaten, 22201
- Rekrutierung
- Virginia Cancer Specialists
-
Richmond, Virginia, Vereinigte Staaten, 23249
- Rekrutierung
- Richmond VA Medical Center
-
Richmond, Virginia, Vereinigte Staaten, 23298
- Rekrutierung
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Lacey, Washington, Vereinigte Staaten, 98503
- Rekrutierung
- Providence Regional Cancer System
-
Seattle, Washington, Vereinigte Staaten, 98109
- Rekrutierung
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Rekrutierung
- Medical College Of Wisconsin
-
-
-
-
-
Birmingham, Vereinigtes Königreich, B9 5ST
- Rekrutierung
- Birmingham Heartlands Hospital
-
Hull, Vereinigtes Königreich, HU16 5JQ
- Rekrutierung
- Castle Hill Hospital
-
Leeds, Vereinigtes Königreich, LS9 7TF
- Rekrutierung
- St James University Hospital
-
London, Vereinigtes Königreich, EC1A 7BE
- Rekrutierung
- St Bartholomew's Hospital
-
London, Vereinigtes Königreich, SW3 6JJ
- Rekrutierung
- Royal Marsden Hospital
-
London, Vereinigtes Königreich, NW1 2BU
- Rekrutierung
- University College Hospital
-
Northwood, Vereinigtes Königreich, HA6 2RN
- Rekrutierung
- Mount Vernon Cancer Centre
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
- Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
- Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
- Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
- Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
- Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy
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: amivantamab, cetuximab or bevacizumab or 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 who has not received immunotherapy treatments
- Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
- Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Arm A: Amivantamab + FOLFIRI
Participants will receive amivantamab along with FOLFIRI (consisting of 5-fluorouracil, leucovorin calcium [folinic acid] or levoleucovorin, and irinotecan) as a chemotherapy regimen 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.
Andere Namen:
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Andere Namen:
Irinotecan will be administered as chemotherapy regimen. |
|
Aktiver Komparator: Arm B: Cetuximab or Bevacizumab + FOLFIRI
Participants will receive either cetuximab or bevacizumab along with FOLFIRI as a chemotherapy regimen 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.
Andere Namen:
Cetuximab will be administered.
Andere Namen:
Irinotecan will be administered as chemotherapy regimen. Bevacizumab will be administered.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Zeitfenster: Up to 2 years 1 month
|
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 2 years 1 month
|
|
Overall Survival (OS)
Zeitfenster: Up to 4 years 4 months
|
OS is defined as the time from the date of randomization to the date of participant's death due to any cause. |
Up to 4 years 4 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by BICR
Zeitfenster: Up to 4 years 4 months
|
ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria. |
Up to 4 years 4 months
|
|
ORR as Assessed by Investigator
Zeitfenster: Up to 4 years 4 months
|
ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by investigator using RECIST v1.1 criteria. |
Up to 4 years 4 months
|
|
Progression Free Survival as Assessed by Investigator
Zeitfenster: Up to 4 years 4 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 investigator. |
Up to 4 years 4 months
|
|
Duration of Response (DoR) as Assessed by BICR
Zeitfenster: Up to 4 years 4 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. |
Up to 4 years 4 months
|
|
Duration of Response as Assessed by Investigator
Zeitfenster: Up to 4 years 4 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 investigator. |
Up to 4 years 4 months
|
|
Time to Response (TTR) as Assessed by BICR
Zeitfenster: Up to 4 years 4 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 4 years 4 months
|
|
TTR as Assessed by Investigator
Zeitfenster: Up to 4 years 4 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 4 years 4 months
|
|
Progression Free Survival After Subsequent Therapy (PFS2)
Zeitfenster: Up to 4 years 4 months
|
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent systemic anticancer therapy, based on investigator assessment or death, whichever comes first. |
Up to 4 years 4 months
|
|
Disease Control Rate (DCR) as Assessed by BICR
Zeitfenster: Up to 4 years 4 months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as defined by BICR using RECIST v1.1. |
Up to 4 years 4 months
|
|
Disease Control Rate as Assessed by Investigator
Zeitfenster: Up to 4 years 4 months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as assessed by investigator. |
Up to 4 years 4 months
|
|
Time to Treatment Failure
Zeitfenster: Up to 4 years 4 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 4 years 4 months
|
|
Curative Resection (R0) Rate
Zeitfenster: Up to 4 years 4 months
|
Curative resection (R0) rate is defined as the percentage of randomized participants who underwent curative-intent surgery where the residual tumor classification was R0. |
Up to 4 years 4 months
|
|
Number of Participants with Adverse Events (AEs) by Severity
Zeitfenster: Up to 4 years 4 months
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe 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 4 years 4 months
|
|
Number of Participants with Abnormalities in Laboratory Values
Zeitfenster: Up to 4 years 4 months
|
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported. |
Up to 4 years 4 months
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Zeitfenster: From baseline up to 4 years 4 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 4 years 4 months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
Zeitfenster: Up to 4 years 4 months
|
Time to worsening in symptoms and functioning as measured by EORTC QLQ-C30 score will be reported. 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. |
Up to 4 years 4 months
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29) Score
Zeitfenster: From baseline up to 4 years 4 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 4 years 4 months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29 Score
Zeitfenster: Up to 4 years 4 months
|
Time to worsening in symptoms and functioning as measured by EORTC QLQ-CR29 will be reported. 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. Change from baseline in the EORTC QLQ-CR29 score will be reported. |
Up to 4 years 4 months
|
|
Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score
Zeitfenster: Up to 4 years 4 months
|
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 indicates severe symptoms. |
Up to 4 years 4 months
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Darmerkrankungen
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Darmerkrankungen
- Kolorektale Neubildungen
- Aminosäuren, Peptide und Proteine
- Proteine
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Camptothecin
- Alkaloide
- Enzyme und Coenzyme
- Antikörper, monoklonal, humanisiert
- Antikörper, monoklonal
- Antikörper
- Immunglobuline
- Immunoproteine
- Blutproteine
- Serumglobuline
- Globuline
- Pyrimidine
- Formyltetrahydrofolate
- Tetrahydrofolate
- Folsäure
- Pterins
- Pteridine
- Uracil
- Pyrimidinone
- Coenzyme
- Bevacizumab
- Irinotecan
- Cetuximab
- Fluoruracil
- Leucovorin
- Levoleucovorin
- Amivantamab
Andere Studien-ID-Nummern
- 61186372COR3002
- 2024-513853-66-00 (Registrierungskennung: EUCT number)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .