- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01285609
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Cordoba, Argentinië, X5006HBF
- Local Institution
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Cordoba, Argentinië, X5006IKK
- Local Institution
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Mendoza, Argentinië, M5500AYB
- Local Institution
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Santa Fe, Argentinië, S3000FFU
- Local Institution
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Buenos Aires
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Quilmes, Buenos Aires, Argentinië, B1878DVB
- Local Institution
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Santa FE
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Rosario, Santa FE, Argentinië, S2000DSV
- Local Institution
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Tucuman
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San Miguel De Tucuman, Tucuman, Argentinië, 4000
- Local Institution
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South Australia
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Bedford Park, South Australia, Australië, 5042
- Local Institution
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Victoria
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Box Hill, Victoria, Australië, 3128
- Local Institution
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Frankston, Victoria, Australië, 3199
- Local Institution
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Heidelberg, Victoria, Australië, 3084
- Local Institution
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Wodonga, Victoria, Australië, 3690
- Local Institution
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Aalst, België, 9300
- Local Institution
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Liege, België, 4000
- Local Institution
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Sint Niklaas, België, 9100
- Local Institution
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Yvoir, België, 5530
- Local Institution
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Porto Alegre, Brazilië, 90430
- Local Institution
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Ribeirao Preto, Brazilië, 14015
- Local Institution
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Rio de Janeiro, Brazilië, 20231-050
- Local Institution
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Sao Paulo, Brazilië, 01224-010
- Local Institution
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Sao Paulo, Brazilië, 04039-901
- Local Institution
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Ceara
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Fortaleza, Ceara, Brazilië, 60160-230
- Local Institution
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazilië, 30150-270
- Local Institution
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Parana
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Curitiba, Parana, Brazilië, 81520-060
- Local Institution
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RIO Grande DO SUL
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Passo Fundo, RIO Grande DO SUL, Brazilië, 99010260
- Local Institution
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SAO Paulo
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Barretos, SAO Paulo, Brazilië, 14784
- Local Institution
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Sao Jose dos Campos, SAO Paulo, Brazilië, 12245
- Local Institution
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Oshawa, Canada, L1G 2B9
- Local Institution
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- Local Institution
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Montreal, Quebec, Canada, H3T 1E2
- Local Institution
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Montreal, Quebec, Canada, H4J 1C5
- Local Institution
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Metropolitana
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Santiago, Metropolitana, Chili, 7520378
- Local Institution
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Santiago, Metropolitana, Chili, 8380455
- Local Institution
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Valparaiso
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Vina Del Mar, Valparaiso, Chili, 2540364
- Local Institution
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Beijing, China, 100032
- Local Institution
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Beijing, China, 100071
- Local Institution
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Beijing, China, 100142
- Local Institution
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Beijing, China, 100853
- Local Institution
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Santiago, China, 7630370
- Local Institution
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Shanghai, China, 200030
- Local Institution
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Shanghai, China, 200433
- Local Institution
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Local Institution
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Guanzhou, Guangdong, China, 510080
- Local Institution
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Shantou, Guangdong, China, 515041
- Local Institution
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Hubei
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Wuhan, Hubei, China, 430023
- Local Institution
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Jiangsu
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Nanjing, Jiangsu, China, 210002
- Local Institution
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Nanjing, Jiangsu, China, 210009
- Local Institution
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Suzhou, Jiangsu, China, 215006
- Local Institution
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Jilin
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Changchun, Jilin, China, 130012
- Local Institution
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Shaanxi
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Xi'an, Shaanxi, China, 710038
- Local Institution
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Xi'an, Shaanxi, China, 710061
- Local Institution
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Xinjiang
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Urumqi, Xinjiang, China, 830011
- Local Institution
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Local Institution
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Cordoba
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Monteria, Cordoba, Colombia
- Local Institution
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Risaralda
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Pereira, Risaralda, Colombia
- Local Institution
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Aalborg, Denemarken, 9000
- Local Institution
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Herlev, Denemarken, 2730
- Local Institution
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Hillerod, Denemarken, 3400
- Local Institution
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Naestved, Denemarken, 4700
- Local Institution
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Odense, Denemarken, 5000
- Local Institution
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Bad Berka, Duitsland, 99437
- Local Institution
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Bochum, Duitsland, 44791
- Local Institution
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Darmstadt, Duitsland, 64283
- Local Institution
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Dresden, Duitsland, 01307
- Local Institution
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Frankfurt Am Main, Duitsland, 60590
- Local Institution
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Gauting, Duitsland, 82131
- Local Institution
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Grosshandsdorf, Duitsland, 22927
- Local Institution
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Hamburg, Duitsland, D-21075
- Local Institution
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Heidelberg, Duitsland, 69126
- Local Institution
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Kassel, Duitsland, 34125
- Local Institution
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Lubeck, Duitsland, 23538
- Local Institution
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Mainz, Duitsland, 55131
- Local Institution
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Muenchen, Duitsland, 81925
- Local Institution
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Neumunster, Duitsland, 24534
- Local Institution
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Nuernberg, Duitsland, 90419
- Local Institution
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Regensburg, Duitsland, 93049
- Local Institution
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Tuebingen, Duitsland, 72076
- Local Institution
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Ulm, Duitsland, 89081
- Local Institution
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Villingen-Schwenningen, Duitsland, 78052
- Local Institution
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Caen Cedex 05, Frankrijk, 14076
- Local Institution
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Marseille Cedex 20, Frankrijk, 13915
- Local Institution
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Paris, Frankrijk, 75014
- Local Institution
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Poitiers, Frankrijk, 86000
- Local Institution
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Rennes Cedex 9, Frankrijk, 35033
- Local Institution
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Toulouse Cedex 9, Frankrijk, 31059
- Local Institution
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Vandoeuvre-les-nancy, Frankrijk, 54511
- Local Institution
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Budapest, Hongarije, 1121
- Local Institution
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Budapest, Hongarije, 1125
- Local Institution
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Deszk, Hongarije, 6772
- Local Institution
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Farkasgyepu, Hongarije, 8582
- Local Institution
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Gyula, Hongarije, 5703
- Local Institution
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Matrahaza, Hongarije, 3233
- Local Institution
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Nyiregyhaza, Hongarije, 4400
- Local Institution
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Pecs, Hongarije, 7602
- Local Institution
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Sopron, Hongarije, 9400
- Local Institution
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Szekesfehervar, Hongarije, 8000
- Local Institution
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Szolnok, Hongarije, 5000
- Local Institution
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Hong Kong, Hongkong, 8525
- Local Institution
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Hong Kong, Hongkong
- Local Institution
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New Territories, Hongkong, 8520
- Local Institution
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Dublin, Ierland, 24
- Local Institution
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Dublin, Ierland, 4
- Local Institution
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Dublin, Ierland, 8
- Local Institution
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Galway, Ierland
- Local Institution
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Beer Sheva, Israël, 84101
- Local Institution
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Haifa, Israël, 31096
- Local Institution
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Jerusalem, Israël, 91120
- Local Institution
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Nahariya, Israël, 22100
- Local Institution
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Petah-Tikva, Israël, 49100
- Local Institution
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Rehovot, Israël, 76100
- Local Institution
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Tel Aviv, Israël, 64239
- Local Institution
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Tel-aviv, Israël, 69710
- Local Institution
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Tel-hashomer, Israël, 52621
- Local Institution
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Zerifin, Israël, 70300
- Local Institution
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Benevento, Italië, 82100
- Local Institution
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Bologna, Italië, 40138
- Local Institution
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Lido Di Camaiore, Italië, 55041
- Local Institution
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Lucca, Italië, 55100
- Local Institution
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Monza, Italië, 20052
- Local Institution
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Padova, Italië, 35128
- Local Institution
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Perugia, Italië, 06156
- Local Institution
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Siena, Italië, 53100
- Local Institution
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Sondrio, Italië, 23100
- Local Institution
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Terni, Italië, 05100
- Local Institution
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Treviglio, Italië, 24047
- Local Institution
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Akashi, Hyogo, Japan, 6738558
- Local Institution
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Fukuoka, Japan, 8128582
- Local Institution
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Matsuyama, Ehime, Japan, 791-0280
- Local Institution
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Osakasayama-city, Japan, 5898511
- Local Institution
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Sapporo Hokkaido, Japan, 003-080
- Local Institution
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Sapporo, Hokkaido, Japan, 0608648
- Local Institution
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Sendai, Miyagi, Japan, 980-0873
- Local Institution
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Takatsuki, Japan, 569-8686
- Local Institution
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Tokyo, Japan, 135-8550
- Local Institution
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Aichi
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Nagoya, Aichi, Japan, 4648681
- Local Institution
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Nagoya-shi, Aichi, Japan, 4600001
- Local Institution
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- Local Institution
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Ishikawa
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Kanazawa-shi, Ishikawa, Japan, 9208641
- Local Institution
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Kanagawa
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Yokohama-Shi, Kanagawa, Japan, 2360051
- Local Institution
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Yokohama-shi, Kanagawa, Japan, 2408555
- Local Institution
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Miyagi
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Natori-shi, Miyagi, Japan, 9811293
- Local Institution
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Sendai, Miyagi, Japan, 9808574
- Local Institution
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Okayama
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Kurashiki-shi, Okayama, Japan, 7010192
- Local Institution
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Kurashiki-shi, Okayama, Japan, 710-8602
- Local Institution
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Osaka
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Hirakata-shi, Osaka, Japan, 5731191
- Local Institution
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Osaka-shi, Osaka, Japan, 5340021
- Local Institution
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Shizuoka
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Sunto-gun, Shizuoka, Japan, 411-8777
- Local Institution
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Tokyo
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Chuo-ku, Tokyo, Japan, 104-0045
- Local Institution
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Yamaguchi
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Ube-shi, Yamaguchi, Japan, 7550241
- Local Institution
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Busan, Korea, republiek van, 602-739
- Local Institution
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Daegu, Korea, republiek van, 700-712
- Local Institution
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Gyeonggi-do, Korea, republiek van, 463-802
- Local Institution
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Seoul, Korea, republiek van, 110-744
- Local Institution
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Seoul, Korea, republiek van, 138-736
- Local Institution
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Seoul, Korea, republiek van, 134-791
- Local Institution
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Seoul, Korea, republiek van, 135-720
- Local Institution
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Seoul, Korea, republiek van, 136-705
- Local Institution
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Seoul, Korea, republiek van, 137-701
- Local Institution
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Seoul, Korea, republiek van, 156-755
- Local Institution
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Suwon, Korea, republiek van, 443-721
- Local Institution
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Chungcheongbuk-do
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Cheonju-si, Chungcheongbuk-do, Korea, republiek van, 361-771
- Local Institution
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, republiek van, 410-769
- Local Institution
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Suwon-si, Gyeonggi-do, Korea, republiek van, 442-723
- Local Institution
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Kangnam-gu
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Seoul, Kangnam-gu, Korea, republiek van, 135-710
- Local Institution
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Seodaemungu
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Seoul, Seodaemungu, Korea, republiek van, 120-752
- Local Institution
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Distrito Federal
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Mexico, Distrito Federal, Mexico, 06760
- Local Institution
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Jalisco
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Zapopan, Jalisco, Mexico, 45170
- Local Institution
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Nuevo LEON
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Monterrey, Nuevo LEON, Mexico, 64060
- Local Institution
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Breda, Nederland, 4818 CK
- Local Institution
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Harderwijk, Nederland, 3844 DG
- Local Institution
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Hertogenbosch, Nederland, 5223 GZ
- Local Institution
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Nieuwegein, Nederland, 3435 CM
- Local Institution
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Graz, Oostenrijk, 8036
- Local Institution
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Linz, Oostenrijk, 4020
- Local Institution
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Salzburg, Oostenrijk, 5020
- Local Institution
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Arequipa, Peru
- Local Institution
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Cercado, Peru
- Local Institution
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Lima, Peru, LIMA 11
- Local Institution
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LA Libertad
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Trujillo, LA Libertad, Peru
- Local Institution
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Elblag, Polen, 82-300
- Local Institution
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Gdansk, Polen, 80-952
- Local Institution
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Gdansk- Zaspa, Polen, 80-462
- Local Institution
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Grudziadz, Polen, 86-300
- Local Institution
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Olsztyn, Polen, 10-357
- Local Institution
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Otwock, Polen, 05-400
- Local Institution
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Poznan, Polen, 60 569
- Local Institution
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Szczecin, Polen, 70-891
- Local Institution
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Torun, Polen, 87-100
- Local Institution
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Warsaw, Polen, 02-781
- Local Institution
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Lisboa, Portugal, 1099023
- Local Institution
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Lisboa, Portugal, 1769-001
- Local Institution
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Porto, Portugal, 4200-072
- Local Institution
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Santa Maria Da Feira, Portugal, 4520211
- Local Institution
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Vila Nova De Gaia, Portugal, 4434-502
- Local Institution
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Coimbra
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Sao Martinho Do Bispo, Coimbra, Portugal, 3041801
- Local Institution
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Bucharest, Roemenië, 030171
- Local Institution
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Bucuresti, Roemenië, 010976
- Local Institution
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Cluj Napoca, Roemenië, 400058
- Local Institution
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Sibiu, Roemenië, 550245
- Local Institution
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Suceava, Roemenië, 720237
- Local Institution
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Timisoara, Roemenië, 300239
- Local Institution
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Chelyabinsk, Russische Federatie, 454087
- Local Institution
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Kazan, Russische Federatie, 420029
- Local Institution
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Moscow, Russische Federatie, 115478
- Local Institution
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Moscow, Russische Federatie, 125009
- Local Institution
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Pyatigorsk, Russische Federatie, 357502
- Local Institution
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Saint Petersburg, Russische Federatie, 197758
- Local Institution
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St-Peterburg, Russische Federatie, 198255
- Local Institution
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St. Petersburg, Russische Federatie, 197022
- Local Institution
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Tula, Russische Federatie, 300053
- Local Institution
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Singapore, Singapore, 308433
- Local Institution
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Avila, Spanje, 05004
- Local Institution
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Benidorm-alicante, Spanje, 03501
- Local Institution
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Castellon, Spanje, 12002
- Local Institution
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Madrid, Spanje, 28041
- Local Institution
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Madrid, Spanje, 28033
- Local Institution
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Manresa, Spanje, 08243
- Local Institution
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Ourense, Spanje, 32005
- Local Institution
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Valencia, Spanje, 46014
- Local Institution
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Valencia, Spanje, 46015
- Local Institution
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Vizcaya
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Barakaldo, Vizcaya, Spanje, 48903
- Local Institution
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Changhua City, Taiwan, 500
- Local Institution
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Chiayi, Taiwan, 61363
- Local Institution
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Kaohsiung County, Taiwan, 83301
- Local Institution
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Taichung, Taiwan, 404
- Local Institution
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Taichung, Taiwan, 407.5
- Local Institution
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Taipei, Taiwan, 112
- Local Institution
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Taipei, Taiwan
- Local Institution
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Taipei City, Taiwan, 100
- Local Institution
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Bangkok, Thailand, 10400
- Local Institution
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Bangkok, Thailand, 10700
- Local Institution
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Bangkok, Thailand, 10330
- Local Institution
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Chiang Mai, Thailand, 50200
- Local Institution
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Songkhla, Thailand, 90110
- Local Institution
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Tungpayathai
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Bangkok, Tungpayathai, Thailand, 10400
- Local Institution
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Prague 2, Tsjechië, 12808
- Local Institution
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Praha 5, Tsjechië, 150 06
- Local Institution
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Praha 8, Tsjechië, 180 81
- Local Institution
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Pribram V-Zdabor, Tsjechië, 26195
- Local Institution
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Usti Nad Labem, Tsjechië, 401 13
- Local Institution
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Znojmo, Tsjechië, 669 02
- Local Institution
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Poruba
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Ostrava, Poruba, Tsjechië, 70852
- Local Institution
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Nottingham, Verenigd Koninkrijk, NG51PB
- Local Institution
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Sheffield, Verenigd Koninkrijk, S10 2SJ
- Local Institution
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Angus/forfarshire
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Dundee, Angus/forfarshire, Verenigd Koninkrijk, DD1 9SY
- Local Institution
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Cornwall
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Truro, Cornwall, Verenigd Koninkrijk, TR1 3LJ
- Local Institution
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Hampshire
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Southampton, Hampshire, Verenigd Koninkrijk, SO16 6YD
- Local Institution
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California
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San Diego, California, Verenigde Staten, 92123
- Sharp Memorial Hospital
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Connecticut
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West Haven, Connecticut, Verenigde Staten, 06516
- VA Connecticut Healthcare System
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Florida
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Boca Raton, Florida, Verenigde Staten, 33486
- Lynn Cancer Institute Center For Hematology-Oncology
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Jacksonville, Florida, Verenigde Staten, 32256
- Integrated Community Oncology Network
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- University of Illinois at Chicago Medical Center
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Quincy, Illinois, Verenigde Staten, 62301
- Quincy Medical Group
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Skokie, Illinois, Verenigde Staten, 60076
- Presence Medical Group Hematology Oncology
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Springfield, Illinois, Verenigde Staten, 62794-9678
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46237
- St. Francis Hospital & Health Centers
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New Albany, Indiana, Verenigde Staten, 47150
- Floyd Memorial Cancer Center of Indiana
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Kentucky
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Hazard, Kentucky, Verenigde Staten, 41701
- Kentucky Cancer Clinic
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Louisville, Kentucky, Verenigde Staten, 40207
- Norton Cancer Institute
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Mount Sterling, Kentucky, Verenigde Staten, 40353
- Montgomery Cancer Center
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Michigan
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Ypsilanti, Michigan, Verenigde Staten, 48197
- St Joseph Mercy Hospital
-
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64131
- University of Kansas Cancer Center
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Saint Louis, Missouri, Verenigde Staten, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756-0001
- Dartmouth-Hitchcock Medical Center
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New York
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Lake Success, New York, Verenigde Staten, 11042
- Clinical Research Alliance, Inc.
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27705
- Durham Va Medical Center (111g)
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Huntersville, North Carolina, Verenigde Staten, 28078
- Carolina BioOncology Institute
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Lexington, North Carolina, Verenigde Staten, 27295
- Novant Health Oncology Specialists
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Ohio
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Canton, Ohio, Verenigde Staten, 44718
- Gabrail Cancer Center Research
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Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74146
- Oklahoma Oncology And Hematology, Pc Dba
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Oregon
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Portland, Oregon, Verenigde Staten, 97227
- Kaiser Permanente Northwest Region
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Pennsylvania
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Sayre, Pennsylvania, Verenigde Staten, 18840
- Guthrie Medical Group, P.C.
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South Carolina
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Columbia, South Carolina, Verenigde Staten, 29209
- WJB Dorn VA Medical Center
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Greenville, South Carolina, Verenigde Staten, 29615
- Cancer Center Of The Carolinas
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten, 37421
- Associated in Oncology and Hematology
-
Knoxville, Tennessee, Verenigde Staten, 37909
- Tennessee Cancer Specialists
-
Knoxville, Tennessee, Verenigde Staten, 37916
- Thompson Oncology Group
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Texas
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Austin, Texas, Verenigde Staten, 78745
- Texas Oncology, PA - South Austin Cancer Center
-
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Virginia
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Blacksburg, Virginia, Verenigde Staten, 24060
- Blue Ridge Cancer Care
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53705
- Wisconsin Institutes for Medical Research
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-
-
-
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Cape Town, Zuid-Afrika, 7925
- Local Institution
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Durban, Zuid-Afrika, 4067
- Local Institution
-
-
Gauteng
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Vereeniging, Gauteng, Zuid-Afrika, 1939
- Local Institution
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Western CAPE
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Panorama,cape Town, Western CAPE, Zuid-Afrika, 7500
- Local Institution
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-
-
-
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Gothenburg, Zweden, 413 45
- Local Institution
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Lund, Zweden, 221 85
- Local Institution
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Stockholm, Zweden, 17176
- Local Institution
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Umea, Zweden, SE-901 85
- Local Institution
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-
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Basel, Zwitserland, 4031
- Local Institution
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Winterthur, Zwitserland, 8401
- Local Institution
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- Non small cell lung cancer (NSCLC) - squamous cell
- Stage IV or recurrent NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Brain Metastases
- Autoimmune diseases
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Ipilimumab + Paclitaxel and Carboplatin
Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses |
Andere namen:
Andere namen:
Andere namen:
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Placebo-vergelijker: Placebo + Paclitaxel and Carboplatin
Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses |
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Tijdsspanne: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Overall Survival (OS) was defined as the time from randomization to the date of death.
Participants that had not died were censored at last known date alive.
Median OS time was calculated using Kaplan-Meier Estimates.
Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
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Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Overall Survival (OS) in All Randomized Participants at Primary Endpoint
Tijdsspanne: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
|
Overall Survival (OS) was defined as the time from randomization to the date of death.
Participants that had not died were censored at last known date alive.
Median OS time was calculated using Kaplan-Meier Estimates.
Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
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Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint
Tijdsspanne: Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first.
A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death.
For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.
For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
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Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Longneoplasmata
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Antineoplastische middelen, immunologisch
- Immuun Checkpoint-remmers
- Carboplatine
- Paclitaxel
- Ipilimumab
Andere studie-ID-nummers
- CA184-104
- 2009-017396-19 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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