A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (OrigAMI-2)
Last Updated May 28, 2025
Want to learn how to participate in this trial?
61186372COR3001
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 3 -
Sites
Sites -
Status
Recruiting
SUMMARY
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.
CONDITIONS
- Colorectal Neoplasms
ELIGIBILITY
Inclusion Criteria:
* Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
* Be diagnosed to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene ho
DETAILS
LOCATIONS
Locations in:
United States, Belgium, Japan, Malaysia, Taiwan, Brazil, China, France, Germany, India, Israel, Italy, South Korea, Netherlands, Poland, Puerto Rico, Spain, Sweden, Türkiye, United Kingdom, Canada, Hungary
| Country (22) | City or Province (180) | Status |
| United States | Los Alamitos Cancer and Blood Specialty Clinic |
RECRUITING
|
| United States | Santa Rosa Providence Medical Foundation |
RECRUITING
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| United States | Baltimore MedStar Franklin Square Medical Center |
RECRUITING
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| United States | Omaha Nebraska Cancer Specialists Midwest Cancer Center |
RECRUITING
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| United States | Las Vegas Comprehensive Cancer Centers of Nevada |
RECRUITING
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| United States | Temple Baylor Scott and White Health |
RECRUITING
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| Belgium | Kortrijk Az Groeninge |
RECRUITING
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| Japan | Chuo Ku National Cancer Center Hospital |
RECRUITING
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| Japan | Osaka-Shi National Hospital Organization Osaka National Hospital |
RECRUITING
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| Japan | Suita Osaka University Hospital |
RECRUITING
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| Japan | Tokyo The Cancer Institute Hospital of JFCR |
RECRUITING
|
| Malaysia | Cheras Hospital Canselor Tuanku Muhriz UKM |
RECRUITING
|
| Malaysia | Georgetown Hospital Pulau Pinang |
RECRUITING
|
| Malaysia | Ipoh Hospital Raja Permaisuri Bainun |
RECRUITING
|
| Malaysia | Kuala Lumpur Hospital Kuala Lumpur |
RECRUITING
|
| Malaysia | Kuala Lumpur University Malaya Medical Centre |
RECRUITING
|
| Malaysia | Kuching Hospital Umum Sarawak |
RECRUITING
|
| Malaysia | Putrajaya National Cancer Institute |
RECRUITING
|
| Taiwan | Kaohsiung Kaohsiung Medical University Chung Ho Memorial Hospital |
RECRUITING
|
| Taiwan | Tainan National Cheng Kung University Hospital |
RECRUITING
|
| Taiwan | Taipei National Taiwan University Hospital |
RECRUITING
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| Taiwan | Taoyuan Linkou Chang Gung Memorial Hospital |
RECRUITING
|
| United States | Jonesboro St. Bernard's Medical Center |
RECRUITING
|
| United States | New Haven Yale University School Of Medicine |
RECRUITING
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| United States | Atlanta Grady Memorial Hospital |
RECRUITING
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| United States | Atlanta Winship Cancer Institute Emory University |
RECRUITING
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| United States | Fort Wayne Fort Wayne Medical Oncology & Hematology |
RECRUITING
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| United States | Hattiesburg Hattiesburg Clinic |
RECRUITING
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| United States | Saint Louis Washington University School Of Medicine |
RECRUITING
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| United States | New Brunswick Rutgers Cancer Institute |
RECRUITING
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| United States | Chapel Hill University of North Carolina at Chapel Hill |
RECRUITING
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| United States | Cleveland Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion |
RECRUITING
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| United States | Cleveland Taussig Cancer Insititute Cleveland Clinic |
RECRUITING
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| United States | Independence Cleveland Clinic Cancer Center Independence Family Health Center |
RECRUITING
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| United States | Mansfield Cleveland Clinic Cancer Center Mansfield |
RECRUITING
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| United States | Mayfield Heights Cleveland Clinic Cancer Center Hillcrest Hospital |
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| United States | Sandusky Cleveland Clinic Cancer Centers Sandusky |
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| United States | Strongsville Cleveland Clinic Cancer Center Strongsville |
RECRUITING
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| United States | Warrensville Heights Cleveland Clinic Cancer Center South Pointe Hospital |
RECRUITING
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| United States | Wooster Wooster Milltown Specialty and Surgery Center |
RECRUITING
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| United States | Houston MD Anderson Cancer Center |
RECRUITING
|
| United States | Edmonds Swedish Cancer Institute |
RECRUITING
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| United States | Issaquah Swedish Cancer Institute |
RECRUITING
|
| United States | Seattle Swedish Cancer Institute |
RECRUITING
|
| Belgium | Anderlecht Institut Jules Bordet |
RECRUITING
|
| Belgium | Edegem Universitair Ziekenhuis Antwerpen |
RECRUITING
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| Belgium | Gent AZ Maria Middelares |
RECRUITING
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| Belgium | Haine Saint Paul La Louviere Hopital de Jolimont |
RECRUITING
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| Belgium | Leuven Universitair Ziekenhuis Leuven |
RECRUITING
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| Brazil | Jau Fundacao Doutor Amaral Carvalho |
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| Brazil | Santa Maria Clinica de Hematologia e Oncologia Viver Ltda |
RECRUITING
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| Brazil | Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center |
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| China | Beijing Peking University First Hospital |
RECRUITING
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| China | Beijing Beijing Friendship Hospital Capital Medical University |
RECRUITING
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| China | Beijing Beijing Cancer Hospital |
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| China | Beijing Peking University Third Hospital |
RECRUITING
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| China | Guangzhou Guangdong Provincial People's Hospital |
RECRUITING
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| China | Hangzhou The Second Affiliated Hospital of Zhejiang University College of Medicine |
RECRUITING
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| China | Huizhou Huizhou Central People's Hospital |
RECRUITING
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| China | Nanchang The First Affiliated Hospital of NanChang University |
RECRUITING
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| China | Shanghai Fudan University Shanghai Cancer Center |
RECRUITING
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| China | Sichuan West China Hospital of Sichuan University |
RECRUITING
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| China | Taiyuan First Hospital of Shanxi Medical University |
RECRUITING
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| China | Wuhan Hubei Cancer Hospital |
RECRUITING
|
| France | Avignon Cedex 9 Institut Sainte Catherine |
RECRUITING
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| France | Lille Hopital Claude Huriez |
RECRUITING
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| France | Montpellier Institut du Cancer de Montpellier |
RECRUITING
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| France | Paris Hopital Saint Antoine |
RECRUITING
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| France | Pessac Hopital Haut Leveque |
RECRUITING
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| Germany | Berlin Charite Universitatsmedizin Berlin Campus Virchow Klinikum |
RECRUITING
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| Germany | Dresden Universitaetsklinikum Carl Gustav Carus TU Dresden |
RECRUITING
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| Germany | Frankfurt am Main Krankenhaus NorthWest |
RECRUITING
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| Germany | Hamburg Asklepios Klinik Altona |
RECRUITING
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| Germany | Munich Klinikum der Universitaet Muenchen |
RECRUITING
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| India | Delhi Rajiv Gandhi Cancer Institute and Research Centre |
RECRUITING
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| India | Kolkata B P Poddar Hospital and Medical research Limited |
RECRUITING
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| India | Pune Deenanath Mangeshkar Hospital and Research Centre |
RECRUITING
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| Israel | Beer Yaakov Yitzhak Shamir Medical Center |
RECRUITING
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| Israel | Haifa Rambam Medical Center |
RECRUITING
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| Israel | Jerusalem Hadassah University Hospita Ein Kerem |
RECRUITING
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| Israel | Petah Tikva Rabin Medical Center |
RECRUITING
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| Israel | Ramat Gan Sheba Medical Center |
RECRUITING
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| Israel | Tel Aviv Yafo Tel Aviv Sourasky Medical Center |
RECRUITING
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| Israel | Tel Aviv Yafo Assuta MC |
RECRUITING
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| Italy | Meldola Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori |
RECRUITING
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| Italy | Pisa Azienda Ospedaliero Universitaria Pisana |
RECRUITING
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| Italy | Rozzano Istituto Clinico Humanitas |
RECRUITING
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| Japan | Chiba Chiba Cancer Center |
RECRUITING
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| Japan | Kashiwa National Cancer Center Hospital East |
RECRUITING
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| Japan | Nagoya Shi Aichi Cancer Center |
RECRUITING
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| Japan | Osaka City Osaka International Cancer Institute |
RECRUITING
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| Japan | Shizuoka Shizuoka Cancer Center |
RECRUITING
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| South Korea | Daegu Kyungpook National University Chilgok Hospital |
RECRUITING
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| South Korea | Seoul Seoul National University Hospital |
RECRUITING
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| South Korea | Seoul Severance Hospital Yonsei University Health System |
RECRUITING
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| South Korea | Seoul Asan Medical Center |
RECRUITING
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| South Korea | Seoul Samsung Medical Center |
RECRUITING
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| South Korea | Seoul The Catholic University of Korea Seoul St Marys Hospital |
RECRUITING
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| Netherlands | Amersfoort Meander Medisch Centrum |
RECRUITING
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| Netherlands | Nijmegen Radboud University Medical Center |
RECRUITING
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| Netherlands | Tilburg Elisabeth-TweeSteden Ziekenhuis |
RECRUITING
|
| Poland | Biala Podlaska Wojewodzki Szpital Specjalistyczny |
RECRUITING
|
| Poland | Brzozow Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza |
RECRUITING
|
| Poland | Gdansk Uniwersyteckie Centrum Kliniczne |
RECRUITING
|
| Poland | Gliwice Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach |
RECRUITING
|
| Poland | Lodz Instytut Centrum Zdrowia Matki Polki |
RECRUITING
|
| Poland | Olsztyn SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie |
RECRUITING
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| Poland | Opole SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego |
RECRUITING
|
| Poland | Warszawa Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie |
RECRUITING
|
| Puerto Rico | Barrio Monacillos Pan American Center for Oncology Trials LLC |
RECRUITING
|
| Spain | Barcelona Hosp. de La Santa Creu I Sant Pau |
RECRUITING
|
| Spain | Barcelona Hosp Univ Vall D Hebron |
RECRUITING
|
| Spain | Madrid Hosp. Univ. Ramon Y Cajal |
RECRUITING
|
| Spain | Madrid Hosp. Univ. 12 de Octubre |
RECRUITING
|
| Spain | Pamplona Clinica Univ. de Navarra |
RECRUITING
|
| Spain | Sevilla Hosp. Virgen Del Rocio |
RECRUITING
|
| Spain | Valencia Hosp. Clinico Univ. de Valencia |
RECRUITING
|
| Sweden | Goteborg Sahlgrenska University Hospital |
RECRUITING
|
| Sweden | Lund Skanes universitetssjukhus |
RECRUITING
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| Sweden | Stockholm Sodersjukhuset |
RECRUITING
|
| Sweden | Stockholm Karolinska Universitetssjukhuset |
RECRUITING
|
| Sweden | Uppsala Uppsala University |
RECRUITING
|
| Taiwan | Kaohsiung Kaohsiung Chang Gung Memorial Hospital |
RECRUITING
|
| Türkiye | Ankara Gulhane Egitim ve Arastirma Hastanesi |
RECRUITING
|
| Türkiye | Ankara Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital |
RECRUITING
|
| Türkiye | Ankara Gazi University Hospital |
RECRUITING
|
| Türkiye | Istanbul Bakirkoy Training and Research Hospital |
RECRUITING
|
| Türkiye | İstanbul Marmara University Pendik Training Hospital |
RECRUITING
|
| Türkiye | Konya Necmettin Erbakan University Meram Medical Faculty |
RECRUITING
|
| Türkiye | Sakarya Sakarya University Training and Research Hospital |
RECRUITING
|
| United Kingdom | Cambridge Addenbrooke's Hospital |
RECRUITING
|
| United Kingdom | Hull Castle Hill Hospital |
RECRUITING
|
| United Kingdom | London St Bartholomew's Hospital |
RECRUITING
|
| United Kingdom | Northwood Mount Vernon Cancer Centre |
RECRUITING
|
| United Kingdom | Sutton Royal Marsden Hospital (Sutton) |
RECRUITING
|
| United States | Bakersfield CBCC Global Research |
RECRUITING
|
| United States | Los Angeles USC Norris Comprehensive Cancer Center |
RECRUITING
|
| United States | Torrance Torrance Memorial Physicians Network |
RECRUITING
|
| United States | Washington Georgetown Univ Medical Center Lombardi Cancer Center |
RECRUITING
|
| United States | East Brunswick Astera Cancer Care |
RECRUITING
|
| United States | Albuquerque University of New Mexico Cancer Center |
RECRUITING
|
| United States | New York Mount Sinai |
RECRUITING
|
| United States | New York Herbert Irving Comprehensive Cancer Center Columbia University Medical Center |
RECRUITING
|
| United States | Shirley New York Cancer and Blood Specialists |
RECRUITING
|
| United States | Philadelphia Fox Chase Cancer Center |
RECRUITING
|
| Brazil | Barretos Fundacao Pio XII |
RECRUITING
|
| Brazil | Caxias do Sul Fundacao Universidade de Caxias do Sul |
RECRUITING
|
| Brazil | Salvador Hospital Santa Izabel Santa Casa de Misericordia da Bahia |
RECRUITING
|
| Brazil | Sao Jose do Rio Preto Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base |
RECRUITING
|
| Brazil | Vitoria Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia |
RECRUITING
|
| Canada | Calgary Arthur J E Child Comprehensive Cancer Centre |
RECRUITING
|
| Canada | Ottawa Ottawa Hospital |
RECRUITING
|
| Canada | Toronto Princess Margaret Cancer Centre |
RECRUITING
|
| China | Changchun The First Bethune Hospital of Jilin University |
RECRUITING
|
| China | Guangzhou Sun Yat Sen University Cancer Center |
RECRUITING
|
| China | Guangzhou The Sixth Affiliated Hospital Sun Yat sen University |
RECRUITING
|
| China | Hangzhou The First Affiliated Hospital Zhejiang University College of Medicine |
RECRUITING
|
| China | Hangzhou Zhejiang Cancer Hospital |
RECRUITING
|
| China | Shenzhen Peking University Shenzhen Hospital |
RECRUITING
|
| China | Tianjin Tianjin Medical University Cancer Institute and Hospital |
RECRUITING
|
| France | Lyon Hopital Prive Jean Mermoz |
RECRUITING
|
| France | Nantes Cedex 1 CHU Nantes |
RECRUITING
|
| France | Poitiers Cedex CHU De Poitiers |
RECRUITING
|
| France | Villejuif Gustave Roussy |
RECRUITING
|
| Germany | Essen Essen University Hospital |
RECRUITING
|
| Germany | Freiburg Praxis fur interdisziplinare Onkologie & Hamatologie GbR |
RECRUITING
|
| Germany | Ulm Universitatsklinikum Ulm |
RECRUITING
|
| Hungary | Budapest Semmelweis Egyetem |
RECRUITING
|
| Hungary | Eger Markhot Ferenc Oktatokorhaz es Rendelointezet |
RECRUITING
|
| Hungary | Pecs Pecsi Tudomanyegyetem |
RECRUITING
|
| India | Mumbai Tata Memorial Hospital |
RECRUITING
|
| Italy | Milano Istituto Dei Tumori Di Milano |
RECRUITING
|
| Italy | Padova Istituto Oncologico Veneto - IRCCS |
RECRUITING
|
| Netherlands | Rotterdam Erasmus MC |
RECRUITING
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| Poland | Bialystok Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku |
RECRUITING
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| Spain | Madrid Hosp. Gral. Univ. Gregorio Maranon |
RECRUITING
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| Türkiye | Adana Adana City Hospital |
RECRUITING
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| United Kingdom | Edinburgh Western General Hospital |
RECRUITING
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| United Kingdom | Leeds St James University Hospital |
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| United Kingdom | London University College Hospital |
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Geo Locations
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38.44047, -122.71443
39.29038, -76.61219
41.25626, -95.94043
36.17497, -115.13722
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