Spots Global Cancer Trial Database for Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
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Trial Identification
Brief Title: Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
Official Title: A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)
Study ID: NCT04550260
Conditions
Study Description
Brief Summary: This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).
Detailed Description: Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in PD-L1 High population.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Atlanta, Georgia, United States
Research Site, Louisville, Kentucky, United States
Research Site, Dallas, Texas, United States
Research Site, Fairfax, Virginia, United States
Research Site, Morgantown, West Virginia, United States
Research Site, Brussel, , Belgium
Research Site, Charleroi, , Belgium
Research Site, Li猫ge, , Belgium
Research Site, Namur, , Belgium
Research Site, Barretos, , Brazil
Research Site, Fortaleza, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, S茫o Jos茅 do Rio Preto, , Brazil
Research Site, Vitoria, , Brazil
Research Site, Barrie, Ontario, Canada
Research Site, Sudbury, Ontario, Canada
Research Site, Anyang, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Bengbu, , China
Research Site, Changsha, , China
Research Site, Changzhi, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Fuzhou, , China
Research Site, Fuzhou, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Hangzhou, , China
Research Site, Hefei, , China
Research Site, Huai'an, , China
Research Site, Jieyang, , China
Research Site, Jinan, , China
Research Site, Kunming, , China
Research Site, Liangyugang, , China
Research Site, Nantong, , China
Research Site, Qingdao, , China
Research Site, Quanzhou, , China
Research Site, Shenzhen, , China
Research Site, Tianjin, , China
Research Site, Xi'an, , China
Research Site, Xuzhou, , China
Research Site, Yangzhou, , China
Research Site, Zhengzhou, , China
Research Site, Zhenjiang, , China
Research Site, BESANCON Cedex, , France
Research Site, Lille, , France
Research Site, Lyon, , France
Research Site, Montpellier, , France
Research Site, Reims, , France
Research Site, Rouen Cedex, , France
Research Site, Strasbourg, , France
Research Site, Villejuif Cedex, , France
Research Site, Bunkyo-ku, , Japan
Research Site, Chuo-ku, , Japan
Research Site, Hidaka-shi, , Japan
Research Site, Hirakata-shi, , Japan
Research Site, Hiroshima-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Kitaadachi-gun, , Japan
Research Site, Koto-ku, , Japan
Research Site, Kumamoto-shi, , Japan
Research Site, Maebashi-shi, , Japan
Research Site, Matsuyama-shi, , Japan
Research Site, Niigata-shi, , Japan
Research Site, Okayama-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Ota-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Shinagawa-ku, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Daegu, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon, , Korea, Republic of
Research Site, Chihuahua, , Mexico
Research Site, Cuernavaca, , Mexico
Research Site, Monterrey, , Mexico
Research Site, M茅rida, , Mexico
Research Site, Veracruz, , Mexico
Research Site, Katowice, , Poland
Research Site, Krak贸w, , Poland
Research Site, Siedlce, , Poland
Research Site, Warszawa, , Poland
Research Site, 艁贸d藕, , Poland
Research Site, Chelyabinsk, , Russian Federation
Research Site, Ekaterinburg, , Russian Federation
Research Site, Krasnodar, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Obninsk, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Sankt-Peterburg, , Russian Federation
Research Site, Tyumen, , Russian Federation
Research Site, Ufa, , Russian Federation
Research Site, Barcelona, , Spain
Research Site, C贸rdoba, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Pamplona, , Spain
Research Site, Santander, , Spain
Research Site, Zaragoza, , Spain
Research Site, Changhua, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Tao-Yuan, , Taiwan
Research Site, Bangkok, , Thailand
Research Site, Bangkok, , Thailand
Research Site, Bangkok, , Thailand
Research Site, Bangkok, , Thailand
Research Site, Chiang Mai, , Thailand
Research Site, Hat Yai, , Thailand
Research Site, Khon Kaen, , Thailand
Research Site, Mueang Chanthaburi, , Thailand
Research Site, Ankara, , Turkey
Research Site, Diyarbakir, , Turkey
Research Site, Erzurum, , Turkey
Research Site, Goztepe Istanbul, , Turkey
Research Site, Izmir, , Turkey
Research Site, Van, , Turkey
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Contact Details
Name: Luhua Wang, MD
Affiliation: Cancer Hospital of Chinese Academy of Medical Science
Role: PRINCIPAL_INVESTIGATOR
Name: Nabil Saba, MD
Affiliation: Department of Hematology and Medical Oncology, Emory University
Role: PRINCIPAL_INVESTIGATOR
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