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Brief Title: Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
Official Title: A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
Study ID: NCT00901901
Brief Summary: This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.
Detailed Description: European quality of life scale (5 dimensions) (EQ-5D)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, San Francisco, California, United States
, Washington, District of Columbia, United States
, Gainesville, Florida, United States
, Miami, Florida, United States
, Atlanta, Georgia, United States
, Honolulu, Hawaii, United States
, Maywood, Illinois, United States
, Westwood, Kansas, United States
, Louisville, Kentucky, United States
, New Orleans, Louisiana, United States
, Baltimore, Maryland, United States
, Boston, Massachusetts, United States
, Boston, Massachusetts, United States
, Worcester, Massachusetts, United States
, Detroit, Michigan, United States
, Minneapolis, Minnesota, United States
, New York, New York, United States
, Rochester, New York, United States
, Valhalla, New York, United States
, Charlotte, North Carolina, United States
, Philadelphia, Pennsylvania, United States
, Houston, Texas, United States
, Seattle, Washington, United States
, Randwick, New South Wales, Australia
, Brisbane, Queensland, Australia
, Herston, Queensland, Australia
, Clayton, Victoria, Australia
, Melbourne, Victoria, Australia
, Nedlands, Western Australia, Australia
, Wien, , Austria
, Bruxelles - Brussel, , Belgium
, Edegem, , Belgium
, Gent, , Belgium
, Kortrijk, , Belgium
, La Louviere, , Belgium
, Leuven, , Belgium
, Liege, , Belgium
, Belo Horizonte, Minas Gerais, Brazil
, Porto Alegre, Rio Grande Do Sul, Brazil
, São Paulo, Sao Paulo, Brazil
, Rio de Janeiro, , Brazil
, Sao Paulo, , Brazil
, Sao Paulo, , Brazil
, Plovdiv, , Bulgaria
, Sofia, , Bulgaria
, Varna, , Bulgaria
, Varna, , Bulgaria
, Edmonton, Alberta, Canada
, Montreal, Quebec, Canada
, Santiago, , Chile
, Santiago, , Chile
, Guangzhou, Guangdong, China
, Nanjing, Jiangsu, China
, Hangzhou, Zhejiang, China
, Beijing, , China
, Beijing, , China
, Floridablanca, , Colombia
, Medellín, , Colombia
, Bordeaux, , France
, Clichy, , France
, Creteil, , France
, La Roche Sur Yon, , France
, Lille, , France
, Lyon, , France
, Marseille, , France
, Paris, , France
, Pessac, , France
, Vandoeuvre-les-nancy, , France
, Villejuif, , France
, Freiburg, Baden-Württemberg, Germany
, Tübingen, Baden-Württemberg, Germany
, München, Bayern, Germany
, Regensburg, Bayern, Germany
, Frankfurt, Hessen, Germany
, Hannover, Niedersachsen, Germany
, Essen, Nordrhein-Westfalen, Germany
, Köln, Nordrhein-Westfalen, Germany
, Mainz, Rheinland-Pfalz, Germany
, Homburg, Saarland, Germany
, Berlin, , Germany
, Athens, , Greece
, Larissa, , Greece
, Thessaloniki, , Greece
, Thessaloniki, , Greece
, Hong Kong, , Hong Kong
, Shatin, , Hong Kong
, Beer Sheva, , Israel
, Haifa, , Israel
, Petah Tikva, , Israel
, Rehovot, , Israel
, Zrifin, , Israel
, Milano, Lombardia, Italy
, Goyang-si, Gyeonggido, Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Auckland, , New Zealand
, Christchurch, , New Zealand
, Wellington South, , New Zealand
, Lima, , Peru
, Lima, , Peru
, Bydgoszcz, , Poland
, Gdansk, , Poland
, Gliwice, , Poland
, Warszawa, , Poland
, Barnaul, , Russian Federation
, Moscow, , Russian Federation
, Nizhny Novgorod, , Russian Federation
, Singapore, , Singapore
, Singapore, , Singapore
, Johannesburg, Gauteng, South Africa
, Cape Town, Western Cape, South Africa
, Hospitalet de Llobregat, Barcelona, Spain
, Barcelona, , Spain
, Lugo, , Spain
, Madrid, , Spain
, Santander, , Spain
, Valencia, , Spain
, Valencia, , Spain
, Tainan, , Taiwan
, Taipei, , Taiwan
, Taoyuan, , Taiwan
, Sheffield, South Yorkshire, United Kingdom
, Glasgow, , United Kingdom
, London, , United Kingdom
, Newcastle Upon Tyne, , United Kingdom
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR