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Brief Title: Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer
Official Title: Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction
Study ID: NCT00678535
Brief Summary: The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) \[XP\] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS). Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research site, Rosario, , Argentina
Research site, Coburg VIC, , Australia
Research site, Frankston, VIC, , Australia
Research site, Perth, , Australia
Research site, Graz, , Austria
Research site, Kufstein, , Austria
Research site, Steyr, , Austria
Research Site, Wien, , Austria
Research Site, Zams, , Austria
Research Site, Bonheiden, , Belgium
Research Site, Bruxelles, , Belgium
Research site, Verviers, , Belgium
Research site, Campinas, , Brazil
Research site, Ijui, , Brazil
Research site, Jaú, , Brazil
Research site, Porto Alegre, , Brazil
Research site, Salvador, , Brazil
Research site, Santo André, , Brazil
Research site, Sâo Paulo, , Brazil
Research site, Pleven, , Bulgaria
Research site, Plovdiv, , Bulgaria
Research site, Rousse, , Bulgaria
Research site, Sofia, , Bulgaria
Research site, Reñaca, , Chile
Research site, Santiago, , Chile
Research site, Temuco, , Chile
Research site, Valparaiso, , Chile
Research site, Beijing, , China
Research site, Guangzhou, , China
Research site, Hefei, , China
Research site, Nanjing, , China
Research site, Shanghai, , China
Research site, Shenyang, , China
Research Site, Brno, , Czech Republic
Research Site, Hradec Králové, , Czech Republic
Research site, Prague 5, , Czech Republic
Research site, Besancon, , France
Research site, Clermont Ferrand Cedex 1, , France
Research site, La Roche sur Yon, , France
Research site, Marseille, , France
Research site, Paris 14, , France
Research site, Rennes, , France
Research Site, Berlin, , Germany
Research site, Bielefeld, , Germany
Research site, Braunschweig, , Germany
Research Site, Dresden, , Germany
Research Site, Essen, , Germany
Research site, Esslingen, , Germany
Research site, Frankfurt, , Germany
Research Site, Giessen, , Germany
Research Site, Hamburg, , Germany
Research Site, Heidelberg, , Germany
Research site, Köln, , Germany
Research site, Ludwigshafen, , Germany
Research Site, Mainz, , Germany
Research Site, München, , Germany
Research site, Offenbach, , Germany
Research Site, Regensburg, , Germany
Research site, Schweinfurt, , Germany
Research Site, Schwäbisch Hall, , Germany
Research site, Stuttgart, , Germany
Research Site, Timisoara, , Germany
Research Site, Troisdorf, , Germany
Research site, Ulm, , Germany
Research site, Weiden, , Germany
Research Site, Weilheim, , Germany
Research site, Ioannina, , Greece
Research site, Thessaloniki, , Greece
Research site, Hong Kong, , Hong Kong
Research site, Budapest, , Hungary
Research site, Gyor, , Hungary
Research Site, Kaposvar, , Hungary
Research Site, Tatabanya, , Hungary
Research site, Haifa, , Israel
Research site, Jerusalem, , Israel
Research site, Petach Tiqva, , Israel
Research site, Ramat Gan, , Israel
Research site, Tel Aviv, , Israel
Research site, Ancona, , Italy
Research site, Bologna, , Italy
Research site, Milano, , Italy
Research site, Napoli, , Italy
Research site, Roma, , Italy
Research site, Rozzano (Milano), , Italy
Research site, Chiba, , Japan
Research site, Ehime, , Japan
Research site, Hokkaido, , Japan
Research site, Koto-ku, , Japan
Research site, Nagoya, , Japan
Research site, Osaka, , Japan
Research site, Saitama, , Japan
Research site, Shizuoka, , Japan
Research site, Tochigi, , Japan
Research site, Tokyo, , Japan
Research site, Yokohama, , Japan
Research site, Anyang, , Korea, Republic of
Research site, Daegu, , Korea, Republic of
Research site, Inchon-si, , Korea, Republic of
Research site, Seongnam, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research site, Gdańsk, , Poland
Research site, Lublin, , Poland
Research site, Opole, , Poland
Research site, Wroclaw, , Poland
Research site, Sana Maria da Feira, , Portugal
Research site, Baia-Mare, , Romania
Research Site, Bucharest, , Romania
Research Site, Cluj-Napoca, , Romania
Research Site, Iasi, , Romania
Research site, Timisoara, , Romania
Research site, Kazan, , Russian Federation
Research site, Moscow, , Russian Federation
Research site, Obninsk, , Russian Federation
Research site, Saint-Petersburg, , Russian Federation
Research Site, Alicante, , Spain
Research site, El Palmar-Murcia, , Spain
Research site, Lugo, , Spain
Research site, Pamplona, , Spain
Research Site, Santander, , Spain
Research site, Seville, , Spain
Research Site, Valencia, , Spain
Research site, Changhua, , Taiwan
Research site, Kaohsiung County, , Taiwan
Research site, Kaohsiung, , Taiwan
Research site, Taichung City, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research site, Taoyuan, , Taiwan
Research site, Guildford, , United Kingdom
Research site, Manchester, , United Kingdom
Name: Florian Lordick, MD, PhD
Affiliation: University Clinic Leipzig, University Cancer Center Leipzig (UCCL), Leipzig Germany
Role: PRINCIPAL_INVESTIGATOR