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A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
Study Purpose
The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 12 Years and Over |
| Gender | All |
- - At least 18 years of age (participants as young as 12 years of age will be allowed if permitted by local regulatory authorities).
- - Histologically or cytologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease.
- - Radiographic progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at screening compared with a previous image taken within the prior 14 months as assessed by the BICR.
- - A defined/acceptable RET gene alteration identified in a tumor, germline deoxyribonucleic acid (DNA) or blood sample.
- - Tumor tissue in sufficient quantity to allow for retrospective central analysis of RET mutation status.
- - Eastern Cooperative Oncology Group performance status score of 0 to 2.
- - Adequate hematologic, hepatic, and renal function and electrolytes.
- - Men and women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 4 months following the last dose of study drug.
- - Ability to swallow capsules.
Exclusion Criteria:
- - An additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment.
- - Symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
- - Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months, history of Torsades de pointes, or prolongation of the QTcF >470 milliseconds on more than one electrocardiogram (ECG) during screening.
- - Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing uncontrolled intercurrent illness.
- - Active hemorrhage or at significant risk for hemorrhage.
- - Other malignancy unless nonmelanoma skin cancer, carcinoma in situ or malignancy diagnosed ≥2 years previously and not currently active.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04211337 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Loxo Oncology, Inc. |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM |
| Principal Investigator Affiliation | Eli Lilly and Company |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Medullary Thyroid Cancer |
| Study Website: | View Trial Website |
Adaptive sample size re-estimation will be performed at interim analysis. The sample size could be increased from approximately 250 to 400 depending on the results of interim analysis.
Arms
Experimental: Selpercatinib - Treatment A (TRT A)
160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).
Active Comparator: Cabozantinib or Vandetanib - Treatment B (TRT B)
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: - 0.7 - <0.9 - 100 mg every other day (QOD) - 0.9 - <1.2 - 100 mg QD - 1.2 - <1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - ≥1.6 - 200 QD
Interventions
Drug: - Selpercatinib
Administered orally
Drug: - Cabozantinib
Administered orally
Drug: - Vandetanib
Administered orally
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35249
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City of Hope National Medical Center
Duarte, California, 91010-0269
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UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles, California, 90095
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Address
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817
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Address
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
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Emory University
Atlanta, Georgia, 30322
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University of Chicago Medical Center
Chicago, Illinois, 60637
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Massachusetts General Hospital
Boston, Massachusetts, 02114
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University of Michigan
Ann Arbor, Michigan, 48109
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Memorial Sloan Kettering Cancer Center
New York, New York, 10017
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University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
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The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
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University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19114
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
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University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792
International Sites
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Royal North Shore Hospital
St Leonards, New South Wales, 2065
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The Alfred Hospital
Melbourne, Victoria, 3004
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Peter MacCallum Cancer Centre
Melbourne, Victoria, 3050
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Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
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Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, , 4000
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Oncocentro
Belo Horizonte, Minas Gerais, 30380-680
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Hospital de Cancer de Londrina
Londrina, Paraná, 86015-520
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Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, 90035-903
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Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400
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Centro de Pesquisa Sao Lucas
Campinas, São Paulo, 13060-904
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Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14051-140
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Hospital Sírio Libanês
Sao Paulo, São Paulo, 01308-060
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Instituto D'Or de Pesquisa e Ensino (IDOR)
Sao Paulo, São Paulo, 04543-000
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Instituto Nacional de Câncer - INCA
Rio de Janeiro, , 20230-130
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Grupo Oncoclínicas Botafogo
Rio de Janeiro, , 22250-905
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Grupo COI - Clínicas Oncológicas Integradas
Rio de Janeiro, , 22775-001
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Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, , 01246-000
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Centro Paulista de Oncologia Clínica
São Paulo, , 01452-000
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
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Anhui Provincial Hospital
Hefei, Anhui, 230071
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Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing, 100730
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Chongqing University Cancer Hospital
Chongqing, Chongqing, 400030
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The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, 350005
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Gansu Cancer Hospital
Lanzhou, Gansu, 730050
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Sun Yat-Sen University Cancer Centre
Guangzhou, Guangdong, 510060
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
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Henan Cancer Hospital
Zhengzhou, Henan, 450008
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Hunan Cancer Hospital
Changsha, Hunan, 410013
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Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
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Jilin Cancer Hospital
Changchun, Jilin, 132000
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Jinan Central Hospital
Jinan, Shandong, 250013
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai, 200032
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West China Hospital, Sichuan University
Cheng Du, Sichuan, 610041
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, 300060
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First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
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Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
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Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
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Address
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, 625 00
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Address
Fakultni nemocnice Motol
Praha, Praha 5, 150 06
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Fakultni nemocnice Olomouc
Olomouc, , 779 00
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Centre Paul Strauss
Strasbourg, Alsace, 67065
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Address
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, 33076
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Address
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, Bouches-du-Rhône, 13915
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Centre François Baclesse
Caen, Calvados, 14076
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Centre Georges François Leclerc
Dijon, Côte-d'Or, 21079
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Address
Institut Claudius Regaud
Toulouse, Haute-Garonne, 31059
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Address
Centre Hospitalier Universitaire d'Angers
Angers, Maine-et-Loire, 49933
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Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59037
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Address
Pitie Salpetriere University Hospital
Paris, Orne, 75013
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Address
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, Puy-de-Dôme, 63011
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Centre Leon Berard
Lyon, Rhône-Alpes, 69008
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Gustave Roussy
Villejuif, Val-de-Marne, 94800
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Klinikum der Universität München Großhadern
München, Bayern, 81337
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Address
Klinikum der Universität München Großhadern
Würzburg, Bayern, 97080
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Medizinische Hochschule Hannover
Hannover, Niedersachsen, 30625
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Address
Universitaetsklinikum Essen
Essen, Nordrhein-Westfalen, 45122
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Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rheinland-Pfalz, 55131
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Otto-von-Guericke-Universität Magdeburg
Magdeburg, Sachsen-Anhalt, 39120
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Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, , 10117
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Address
Hämato-Onkologie Hamburg, Prof. Laack und Partner
Hamburg, , 20251
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Address
Alexandra Hospital
Athina, Attikí, 115 28
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Address
University General Hospital of Heraklion
Heraklion, Irakleío, 711 10
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Address
European Interbalkan Medical Center
Thessaloníki, Thessaloniki, 570 01
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Address
Regional Cancer Centre - Thiruvananthapuram
Thiruvananthapuram, Kerala, 695011
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Address
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422001
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Grant Medical Foundation - Ruby Hall Clinic
Pune, Maharashtra, 411001
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Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004
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Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, 700054
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Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh, , 160012
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Rabin Medical Center
Petah-Tikva, HaMerkaz, 4941492
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Sheba Medical Center
Ramat Gan, HaMerkaz, 5265601
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Hadassah Medical Center
Jerusalem, Yerushalayim, 9112001
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University of Naples Federico II
Napoli, Campania, 80131
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Policlinico Umberto I
Roma, Lazio, 00161
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardia, 20133
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Istituto Auxologico Italiano
Milan, Milano, 20122
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Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Piemonte, 10126
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Istituto Nazionale Tumori Regina Elena
Rome, Roma, 00144
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Azienda Ospedaliera Universitaria Pisana
Pisa, Toscana, 56124
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Ospedale Le Scotte
Siena, Toscana, 53100
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Istituto Oncologico Veneto IRCCS
Padova, Veneto, 35128
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Azienda Ospedaliera Garibaldi
Catania, , 95124
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Aichi Cancer Center Hospital
Nagoya, Aichi, 464-8681
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National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
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Address
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
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Address
Kobe University Hospital
Kobe, Hyogo, 650-0017
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Address
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
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Osaka University Hospital
Suita, Osaka, 565-0871
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Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550
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National Hospital Organization Kyushu Medical Center
Fukuoka, , 810-8563
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Chungbuk National University Hospital
Chungbuk, Chungcheongbuk-do [Chungbuk], 28644
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National Cancer Center
Goyang-si, Kyǒnggi-do, 10408
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Address
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
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Address
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 3080
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Address
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 3722
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Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 6351
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Address
Maastricht UMC+
Maastricht, Limburg, 6229 HX
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Address
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, Noord-Holland, 1066 CX
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Address
Leids Universitair Medisch Centrum
Leiden, Zuid-Holland, 2333 ZA
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Address
University Medical Center Groningen
Groningen, , 9713 GR
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Address
Narodowy Instytut Onkologii - Oddzial w Gliwicach
Gliwice, Śląskie, 44-101
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Address
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Kielce, Świętokrzyskie, 25-734
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Clinic Evimed
Chelyabinsk, Chelyabinskaya Oblast', 454048
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Address
A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological
Obninsk, Kalužskaja Oblast', 249036
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Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
Moscow, Moskva, 115478
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Endocrinology Research Center of Rosmedtechnologies
Moscow, Moskva, 117292
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Saint Petersburg State University
Saint Petersburg, Sankt-Peterburg, 190020
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Saint-Petersburg City Clinical Oncology Dispensary
Saint Petersburg, Sankt-Peterburg, 198255
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Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 8035
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Instituto Catalan de Oncologia - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalunya [Cataluña], 8907
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Address
Institut Català d'Oncologia (ICO) - Girona
Girona, Girona [Gerona], 17007
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Clinica Universidad de Navarra
Madrid, Madrid, Comunidad De, 28027
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Address
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad De, 28034
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Address
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad De, 28041
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Address
Hospital Universitario La Paz
Madrid, Madrid, Comunidad De, 28046
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Address
Hospital Universitario Virgen de la Victoria
Malaga, Málaga, 29010
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Address
Clinica Universidad de Navarra
Pamplona, Navarra, 31008
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Hospital General Universitario Gregorio Marañon
Madrid, , 28009
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Address
Hospital Clinico San Carlos
Madrid, , 28040
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Address
Hospital Universitario Miguel Servet
Zaragoza, , 50009
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Address
Velindre Cancer Centre
Cardiff, Cardiff [Caerdydd Gb-crd], CF14 2TL
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Address
Weston Park Hospital
Sheffield, England, S10 2SJ
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Address
Gartnavel General Hospital
Glasgow, Glasgow City, g12OYN
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Address
Royal Marsden Hospital (Chelsea)
London, Kensington And Chelsea, SW3 6JJ
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University College London Hospital
London, London, City Of, NW1 2PG
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Royal Marsden Hospital (Sutton)
London, Sutton, SM2 5PT
