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Brief Title: Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title: Multicentre Randomised Phase II Trial of Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients (=/> 70 Years) With Advanced Non-Small Cell Lung Cancer
Study ID: NCT00678964
Brief Summary: 60% of all malignant diseases occur in patients who are 65 years or older. For these patients, aggressive treatments are often not suitable due to reduced life-expectancy, reduced general condition, comorbidities, and reduced vital functions which can lead to increased adverse effects of chemotherapy. Therefore, it is important to investigate alternative therapy options for elderly patients. Erlotinib is an orally applied medication which is associated with reasonable toxicity. This targeted agent may prove an effective and well-tolerated first-line therapy in elderly patients with advanced non small cell lung cancer. Therefore, the aim of this study is to investigate the progression-free survival of the combination of vinorelbine and carboplatin in comparison to erlotinib. Given that there will be no significant reduction of efficiency this may provide elderly patients of more than 70 years of age with an active oral substance without subjecting them to the sometimes severe adverse effect of the chemotherapy.
Detailed Description:
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Gemeinschaftspraxis, Augsburg, , Germany
Zentralklinik Bad Berka GmbH, Bad Berka, , Germany
Charité - Campus Benjamin Franklin, Berlin, , Germany
Helios Klinikum Emil von Behring, Berlin, , Germany
Evangelische Lungenklinik Berlin, Berlin, , Germany
Evang. Krankenhaus Bielefeld, Bielefeld, , Germany
Johanniter-Krankenhaus Bonn, Bonn, , Germany
Gemeinschaftspraxis, Celle, , Germany
Fachkrankenhaus Coswig, Coswig, , Germany
Fachklinik Diekholzen, Diekholzen, , Germany
Klinikum Donaustauf, Donaustauf, , Germany
Katholisches Klinikum Duisburg, Duisburg, , Germany
Marien Hospital Düsseldorf, Düsseldorf, , Germany
Universitätsklinik Essen, Essen, , Germany
Klinikum Essen-Mitte, Essen, , Germany
Krankenhaus Nordwest GmbH, Frankfurt/Main, , Germany
Asklepios Fachkliniken München-Gauting, Gauting, , Germany
Schwerpunktpraxis Onkologie, Goslar, , Germany
Universitätsklinikum der Ernst-Moritz Arndt Universität Greifswald, Greifswald, , Germany
Krankenhaus Großhansdorf, Großhansdorf, , Germany
Georg-August-Universität Göttingen, Göttingen, , Germany
Allgemeines Krankenhaus Harburg, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg, , Germany
Lungenklinik Hemer, Hemer, , Germany
Universitätsklinik des Saarlandes, Homburg/Saar, , Germany
Klinikum der Friedrich-Schiller-Universität, Jena, , Germany
Klinikum Kassel, Kassel, , Germany
Malteser Krankenhaus St. Hildegardis Köln, Köln, , Germany
Klinikum Leverkusen gGmbH, Leverkusen, , Germany
Klinik Löwenstein gGmbH, Loewenstein, , Germany
Universitätsklinikum Schleswig-Holstein, Lübeck, , Germany
Katholisches Klinikum Mainz, Mainz, , Germany
Klinikum der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Universitätsklinikum Mannheim gGmbH, Mannheim, , Germany
Zweckverband Kliniken im Mühlenkreis, Minden, , Germany
Medizinische Klinik - Innenstadt, München, , Germany
Ruppiner Kliniken GmbH, Neuruppin, , Germany
Johanniter-Krankenhaus im Fläming gGmbH, Treuenbrietzen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Name: Martin Reck, Dr.
Affiliation: LungenClinic Grosshansdorf
Role: PRINCIPAL_INVESTIGATOR