Trial Condition(s):
Carcinoma, Non-Small Cell Lung
A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel plus or minus Sorafenib (BAY 43-9006) in chemonaive patients with Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
Bayer Identifier:
11961
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.
Inclusion Criteria
- Stage IIIB (with effusion) or Stage IV NSCLC any histology - No prior chemotherapy - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Greater than or equal to 18 years of age - Life expectancy at least 12 weeks - Adequate bone marrow, liver and renal function
Exclusion Criteria
- Prior systemic anti cancer therapy - Known brain metastasis. Patients with neurological symptoms should undergo at computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis - Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks of first dose of study drug - Thrombotic or embolic events including Transient ischemic attack (TIA) within the past 6 months - Uncontrolled hypertension - Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug - Major surgery within 4 weeks - Evidence or history of bleeding diathesis or coagulopathy
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Kliniken der Medizinischen Hochschule Hannover Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lungenklinik Hemer Hemer, Germany, 58675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Innenstadt der Ludwigs-Maximilians-Universität München, Germany, 80336 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Mannheim gGmbH Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Fachkliniken München Gauting Gauting, Germany, 82131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Grosshansdorf Großhansdorf, Germany, 22927 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsmedizin der Georg-August-Universität Göttingen Göttingen, Germany, 37075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pius-Hospital Oldenburg Oldenburg, Germany, 26121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Guy's Hospital London, United Kingdom, SE1 9RT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Berkshire Hematology/Oncology, PC Pittsfield, United States, 01201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gabrail Cancer Center Dover, United States, 44622 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Klinik Harburg Hamburg, Germany, 21075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Leverkusen gGmbH Leverkusen, Germany, 51375 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Essen - Mitte Essen, Germany, 45136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thoraxklinik-Heidelberg gGmbH Heidelberg, Germany, 69126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Hofheim am Taunus Hofheim , Germany, 65719 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Bournemouth General Hospital Bornemouth, United Kingdom, BH7 7DW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Derriford Hospital Plymouth, United Kingdom, PL6 8DH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wythenshawe Hospital Manchester, United Kingdom, M23 9LT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leicester Royal Infirmary Leicester, United Kingdom, LE1 5WW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Oncology Care Associates Orange, United States, 92868 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Morgantown Internal Medicine Group, Inc. Morgantown, United States, 26505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clintell, Inc. Skokie, United States, 60077 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Capital Comprehensive Cancer Care Clinic Jefferson City, United States, 65109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hattiesburg Clinic Hattiesburg, United States, 39401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Outreach Associates Abingdon, United States, 24211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hematology/Oncology of Indiana Indianapolis, United States, 46260 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pacific Oncology/Hematology Associates Encinitas, United States, 92024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Sinai Medical Center New York, United States, 10029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siouxland Hematology/Oncology Associates, LLP Sioux City, United States, 51101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sanford Roger Maris Cancer Center Fargo, United States, 58122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Care Associates Tulsa, United States, 74136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Highlands Oncology Group Springdale, United States, 72764 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. John's Mercy Medical Center St. Louis, United States, 63141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hematology & Oncology Consultants, PA Orlando, United States, 32804 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Watson Clinic Center for Research Lakeland, United States, 33805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tenessee Cancer Specialists Knoxville, United States, 37920 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jayne Gurtler APMC Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Simon-Williamson Clinic, PC Birmingham, United States, 35211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fairfax-Northern Virginia Hematology/Oncology, PC Fairfax, United States, 22031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Joseph Mercy Hospital Ann Arbor, United States, 48106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peachtree Hematology & Oncology Consultants, PC Atlanta, United States, 30309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lehigh Valley Hospital - Cedar Crest Allentown, United States, 18103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oklahoma University Health Science Center Oklahoma City, United States, 73104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hematology/Oncology Clinic Baton Rouge, United States, 70808 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Las Vegas Cancer Center Las Vegas, United States, 89102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Utah Medical Center Salt Lake City, United States, 84112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Centers of the Carolinas Greenville, United States, 29615 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Virginia Oncology Care, PC Richlands, United States, 24641 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arkansas Oncology Associates Little Rock, United States, 72205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kentuckiana Cancer Institute, PLLC Louisville, United States, 40215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Providence Portland Medical Center Portland, United States, 97213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arlington Cancer Center Trophy Club, United States, 76262 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hackensack University Medical Center Hackensack, United States, 07601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hematology/Oncology Associates of Northern New Jersey, PA Morristown, United States, 07962-1089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. William Tester, MD Philadelphia, United States, 19115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hematology & Oncology of Dayton, Inc. Dayton, United States, 45429 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Staten Island University Hospital Staten Island, United States, 10305 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations East Valley Hematology/Oncology Medical Group Burbank, United States, 91595 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Odyssey Research Services Bismarck, United States, 58501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Henry Ford Health System Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncology-Hematology of Lehigh Valley, PC Bethlehem, United States, 18015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sacred Heart Medical Oncology Group Mobile, United States, 36608 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Metropolitan Hematology Oncology Medical Group Los Angeles, United States, 90057 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Chicago Chicago, United States, 60637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kansas City Cancer Centers, LLC Kansas City, United States, 64111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rocky Mountain Cancer Centers Denver, United States, 80218 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Howard Regional Health System-Main Campus Kokomo, United States, 46902 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Compassionate Cancer Care Medical Group, Inc. Corona, United States, 92829 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southeast Nebraska Cancer Center Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northwest Georgia Oncology Centers, PC Marietta, United States, 30060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Indiana University Indianapolis, United States, 46202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Candler Hospital/St. Joseph's Candler Health System Savannah, United States, 31405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fort Wayne Medical Hematology & Oncology Fort Wayne, United States, 46815 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre François Baclesse - CLCC - Caen CAEN, France, 14073 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Olsztyn, Poland, 10-228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersyteckie Centrum Kliniczne Gdansk, Poland, 80-952 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii Instytut im. M. Sklodowskiej-Curie Krakow, Poland, 31-115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dolnoslaskie Centrum Chorób Pluc Wroclaw, Poland, 53-439 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. San Luigi Gonzaga Orbassano, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Città della Salute e della Scienza di Torino Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Perugia Perugia, Italy, 06156 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Nazionale Tumori GE Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Camillo-Forlanini Roma, Italy, 00152 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Parma Parma, Italy, 43100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Policlinico San Matteo Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General de Elche Elche, Spain, 03202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario de Alicante Alicante, Spain, 03010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Clinica Puerta de Hierro Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allan Blair Cancer Centre Regina, Canada, S4T 7T1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allan Blair Cancer Centre Regina, Canada, S4T 7T1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Gävle-Sandviken Gävle, Sweden, 801 87 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Port Macquarie Base Hospital Port Macquarie, Australia, 2444 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southeast Oncology Melbourne, Australia, 3144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Brisbane & Women's Hospital Brisbane, Australia, 4029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southern Medical Day Care Centre Wollongong, Australia, 2500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Médico Platense La Plata, Argentina, B1900AVG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Especializado ISIS Santa Fé, Argentina, S3000FFV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nacional Professor A. Posadas El Palomar - Morón, Argentina, 1684 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto C.A.I.C.I. Rosario, Argentina, 2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Privado de la Comunidad Mar del Plata, Argentina, B7602CBM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Cancer Nuestra Señora de la Esperanza Santiago, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Matrai State Hospital Matrahaza, Hungary, 3233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pest County Lung Institute Torokbalint, Hungary, 2045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital IGESP São Paulo, Brazil, 01331010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundação Pio XII – Hospital de Câncer de Barretos Barretos, Brazil, 14784400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Irmandade da Santa Casa de Misericordia - Sao Paulo São Paulo, Brazil | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Biocor Hospital de Doenzas Cardiovasculares Ltda Nova Lima, Brazil, 34000000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto do Cancer do Ceará Fortaleza, Brazil, 60430-230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Sao Lucas da Pontificia Universidade Catolica do RS Porto Alegre, Brazil, 90619900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Oncologia do Paraná Curitiba, Brazil, 80730-180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CEON - Centro especializado de Oncologia Ribeirao Preto, Brazil, 14015-140 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Luxemburgo Belo Horizonte, Brazil, 30380490 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nossa Senhora da Conceicao Porto Alegre, Brazil, 91350-200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Clinical Oncology Center St. Petersburg, Russia, 198255 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS Moscow, Russia, 115478 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Moscow City Oncological Hospital No62 Moscow, Russia, 143423 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chang-Guang Memorial Hospital Taoyuan, Taiwan, China, 333 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations EPIC Management, LP Highland, United States, 92346 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tower Hematology/Oncology Medical Group Beverly Hills, United States, 90211-1850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Clinical Research of Indiana, LLC Indianapolis, United States, 46254 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Virginia Commonwealth University Richmond, United States, 23298-0037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MD Anderson Cancer Center-Orlando Orlando, United States, 32806 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Virginia Cancer Institute Richmond, United States, 23230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vanderbilt University Medical School Nashville, United States, 37232-6307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MD Anderson Cancer Center-Orlando Orlando, United States, 32806 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North Shore Cancer Research Association Skokie, United States, 60076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charleston Hematology & Oncology Associates, PA Charleston, United States, 29403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Rochester Medical Center Rochester, United States, 14622 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kansas City Cancer Centers, LLC Kansas City, United States, 64131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hematology Oncology Consultants, Inc. Columbus, United States, 43235 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mid-Ohio Oncololgy/Hematology Columbus, United States, 43213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arizona Clinical Research Center Tucson, United States, 85715 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hutchinson Clinic Hutchinson, United States, 67502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pottsville Cancer Center Pottsville, United States, 17901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Space Coast Medical Associates Merritt Island, United States, 32952 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations VA Boston Healthcare System-Jamaica Plain Division Boston, United States, 02130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southern Nevada Cancer Research Foundation Las Vegas, United States, 89106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pacific Cancer Medical Center Anaheim, United States, 92801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations San Juan VA Medical Center San Juan, United States, 00921 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Center of Kansas Wichita, United States, 67214 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Consultants, Ltd. Milwaukee, United States, 53215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Guthrie Clinic Sayre, United States, 18840 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California - Davis Sacramento, United States, 95817 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Avicenne - Bobigny BOBIGNY CEDEX, France, 93009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre d'Oncologie de Gentilly - Nancy NANCY, France, 54100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Percy - Clamart CLAMART, France, 92140 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Antoine Lacassagne - Nice NICE CEDEX 2, France, 06102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Bon Secours - Metz METZ, France, 57000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Lyautey - Strasbourg STRASBOURG, France, 67100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie Warszawa, Poland, 02-781 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 04-141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mazowieckie Centrum Leczenia Ch. Pluc i Gruzlicy Otwock, Poland, 05-400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Parma Parma, Italy, 43100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Osp Niguarda Ca' Granda Milano, Italy, 20162 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedali Riuniti Bergamo Bergamo, Italy, 24128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Ruber Internacional Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Complejo Hospitalario de Pontevedra Pontevedra, Spain, 36001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Complejo Hospitalario de Zamora Zamora, Spain, 49021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario Lozano Blesa Zaragoza, Spain, 50009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario de la Princesa Madrid, Spain, 28006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Sandeep Sehdev, MD Brampton, Canada, L6W 3X4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of British Columbia North Vancouver, Canada, V7L 2L7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Victoria Hospital Barrie, Canada, L4M 6M2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Grand Hôpital de Charleroi CHARLEROI, Belgium, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU de Liège LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CH de Jolimont - Lobbes Site de Jolimont LA LOUVIERE, Belgium, 7100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Isala Klinieken, lokatie Weezenlanden Zwolle, Netherlands, 8011 JW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Catharina EINDHOVEN, Netherlands, 5623 EJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademiska Sjukhuset Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Perth Oncology Perth, Australia, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Burnside War Memorial Hospital Adelaide, Australia, 5065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peninsula Oncology Centre Frankston, Australia, 3199 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General de Agudos Dr. Carlos G. Durand Buenos Aires, Argentina, C1405DCS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Medico Especializado Alexander Fleming Capital Federal-Buenos Aires, Argentina, C1426ANZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Nacional del Cancer Santiago, Chile, 838-0455 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico San Borja Arriarán Santiago, Chile, 836-0156 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital DIPRECA Santiago, Chile, 760 0448 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza Deszk, Hungary, 6772 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orszagos Koranyi TBC es Pulmonologiai Intezet Budapest, Hungary, 1529 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bekes Megyei Tudokorhaz Gyula, Hungary, 5703 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Santa Casa de Misericórdia da Bahia Hospital Santa Izabel Salvador, Brazil, 40050410 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Vila Rica Brasília , Brazil, 70390907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Regional Integrado de Oncologia - CRIO Fortaleza, Brazil, 60336-550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital das Clínicas da Faculdade de Medicina da USP São Paulo, Brazil, 05403-000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Santo Andre Diagnostico e Terapeutica Santo Andre, Brazil, 09090-780 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hosp. Araujo Jorge da Associação de Combate ao Câncer Goiânia, Brazil, 74605-180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Municipal Sao José Joinville, Brazil, 89202-050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Amaral Carvalho Jaú, Brazil, 17210-120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Conjunto Hospitalar de Sorocaba Sorocaba, Brazil, 18030-510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UNIFESP/EPM São Paulo, Brazil, 04024-002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Centre of X-ray and Radiology Moscow, Russia, 117837 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-799 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel plus or minus Sorafenib (BAY 43-9006) in chemonaive patients with Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and PlaceboTimeframe: Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis
Secondary Outcome
- Progression Free Survival (PFS)Timeframe: Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis
- Overall Best ResponseTimeframe: Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis
- Duration of ResponseTimeframe: Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis
- Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)Timeframe: Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (1Oct2007) used for planned formal interim analysis
- Patient Reported Outcome as Assessed by LCS Subsscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)Timeframe: Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (1Oct2007) used for planned formal interim analysis
Additional Information
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