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Brief Title: Phase III Sequential Open-label Study to Evaluate the Efficacy and Safety of Sorafenib Followed by Pazopanib Versus Pazopanib Followed by Sorafenib in the Treatment of Advanced / Metastatic Renal Cell Carcinoma (SWITCH-II)
Official Title: Phase III Randomized Sequential Open-label Study to Evaluate the Efficacy and Safety of Sorafenib Followed by Pazopanib Versus Pazopanib Followed by Sorafenib in the Treatment of Advanced / Metastatic Renal Cell Carcinoma
Study ID: NCT01613846
Brief Summary: Sorafenib and pazopanib are both effective and promising treatments for advanced Renal Cell Carcinoma (RCC). Both drugs are registered for this indication. No prospective comparative data in advanced RCC (or other indications) have been published. A search in the clinicaltrials.gov database did not reveal any planned or ongoing studies. As sequential therapy is now the standard of treatment for advanced RCC it is important to evaluate in clinical trials what the value of different sequential strategies is. This needs to be done every time new agents are introduced into the treatment armamentarium. As there are no data yet on the sequential use of sorafenib followed by pazopanib or vice versa, this sequence, however, will most certainly be used in daily practice, it is required to examine efficacy and safety of this sequential approach in a clinical trial in a randomized setting. Therefore, the investigators have designed an open randomized study in patients not previously treated for advanced RCC. Suitable patients will be randomized (1:1) in 2 groups.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medizinische UniversitÀt Innsbruck, Innsbruck, , Austria
A. ö. Bezirkskrankenhaus Kufstein, Kufstein, , Austria
AKH Linz GmbH, Linz, , Austria
LKH Salzburg, Salzburg, , Austria
UniversitÀtsklinikum Aachen, Urologische Klinik, Aachen, , Germany
Gesundheitszentrum St. Marien GmbH, Amberg, , Germany
Praxis fĂŒr Urologie, Berlin, , Germany
Charite Campus Virchow Klinikum / Klein. FĂŒr Innere Med / Onkologie/HĂ€matologie, Berlin, , Germany
Gemeinschaftspraxis Pott / Tirier / Hannig - Onkologie, Bottrop, , Germany
Urologie im Schlosscarrée Braunschweig, Braunschweig, , Germany
Klinikum Bremen-Mitte gGmbH, Bremen, , Germany
Bethanien Krankenhaus Chemnitz gGmbH, Chemnitz, , Germany
Onkologische Gemeinschaftspraxis Dörfel/Göhler, Dresden, , Germany
UniversitÀtsklinikum Carl Gustav Carus der Technischen UniversitÀt Dresden, Dresden, , Germany
Urologische Gemeinschaftspraxis, Duisburg, , Germany
Krankenhaus DĂŒren gGmbH, DĂŒren, , Germany
UniversitĂ€tsklinikum DĂŒsseldorf, DĂŒsseldorf, , Germany
Urologie Neandertal - OrtsĂŒbergreifende Gemeinschaftspraxis fĂŒr Urologie, Erkrath, , Germany
Waldkrankenhaus St. Marien, Erlangen, , Germany
St.-Antonius-Hospital in Eschweiler / Klinik f. HĂ€matologie und Onkologie, Eschweiler, , Germany
HĂ€mato-onkologische Gemeinschaftspraxis, Essen, , Germany
Onkozentrum Freiberg, Freiberg, , Germany
Praxis fĂŒr interdisziplinĂ€re Onkologie & HĂ€matologie, Freiburg, , Germany
UniversitÀtsklinikum Freiburg, Freiburg, , Germany
MVZ Osthessen GmbH, Fulda, , Germany
Gem.praxis Dres. J. Wilke, H. Wagner - HĂ€matol.u.intern.Onkol. am Klinikum FĂŒrth, FĂŒrth, , Germany
Onkologische Schwerpunktpraxis, Goslar, , Germany
UniversitÀtsmedizin Greifswald, Greifswald, , Germany
St. Antonius-Hospital Gronau GmbH, Gronau, , Germany
UniversitÀtsklinikum Göttingen, Göttingen, , Germany
Onkologische Schwerpunktpraxis, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
UniversitĂ€tsklinikum Heidelberg, Klinik fĂŒr Urologie, Heidelberg, , Germany
Urologie-Heinsberg, Heinsberg, , Germany
Onkologische Praxis, Hildesheim, , Germany
UniversitÀtsklinikum des Saarlandes, Homburg, , Germany
UniversitĂ€tsklinikum Jena, Klinik fĂŒr Urologie, Jena, , Germany
Ăberörtliche Gemeinschaftspraxis, Köln, , Germany
Praxis fĂŒr Urologie, Lauenburg, , Germany
Onkologische Schwerpunktpraxis Leer - Emden, Leer, , Germany
MVZ Mitte/ MVZ Delitzsch GmbH, Leipzig, , Germany
Urologische Facharztpraxis, Lutherstadt Eisleben, , Germany
UniversitÀtsklinikum Magdeburg A.ö.R, Magdeburg, , Germany
UniversitÀtsklinik Mannheim, Mannheim, , Germany
Philips-UniversitÀt-Marburg, Urologie und Kinderurologie, Marburg, , Germany
Praxis Markkleeberg, Markkleeberg, , Germany
Kliniken Maria Hilf, Mönchengladbach, , Germany
PUR/R Praxisklinik Urologie Rhein Rhur, MĂŒhlheim, , Germany
Klinikum r. d. Isar, Klinik fĂŒr Urologie, MĂŒnchen, , Germany
UniversitĂ€tsklinikum MĂŒnster , Klinik fĂŒr Urologie, MĂŒnster, , Germany
Eps- early phase solutions GmbH, PöĂneck, , Germany
Caritas Krankenhaus St. Josef, Regensburg, , Germany
UniversitÀtsklinikum Rostock, Rostock, , Germany
Zentrum fĂŒr Urologie und Onkologie, Rostock, , Germany
Diakoniekrankenhaus Rotenburg (WĂŒmme) gGmbH, Rotenburg (WĂŒmme), , Germany
Klinikum Sindelfingen-Böblingen, Sindelfingen, , Germany
Marienhospital / Innere Med III Onko HĂ€mato Palliativm, Stuttgart, , Germany
Eberhard-Karls-UniversitĂ€t TĂŒbingen, TĂŒbingen, , Germany
UniversitÀtsklinik Ulm, Ulm, , Germany
UniversitÀtsklinikum Ulm, Ulm, , Germany
Praxis fĂŒr HĂ€matologie und internistische Onkologie, Velbert, , Germany
Klinikum Nordoberpfalz AG, Weiden, , Germany
Gesellsch. z. Förd. Von Wissenschaft u.QualitÀtssicherung i.d.ambul.Onkologie, Wiesbaden, , Germany
Praxisgemeinschaft fĂŒr Onkologie und Urologie, Wilhelmshaven, , Germany
Gemeinschaftspraxis fĂŒr Urologie, Wuppertal, , Germany
UniversitĂ€tsklinikum WĂŒrzburg, WĂŒrzburg, , Germany
Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands
Reinier de Graaf Gasthuis, Delft, , Netherlands
HAGA, Den Haag, , Netherlands
Spaarne Ziekenhuis, Hoofddorp, , Netherlands
TweeSteden Ziekenhuis, Tilburg, , Netherlands
VieCuri Medical Center, Venlo, , Netherlands
Name: JĂŒrgen E. Gschwend, Prof.
Affiliation: Klinikum rechts der Isar, TU MĂŒnchen
Role: PRINCIPAL_INVESTIGATOR