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Brief Title: Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
Official Title: Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma
Study ID: NCT00226473
Brief Summary: The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim, Mannheim, Baden-Württemberg, Germany
Dept. of Dermatology, University Hospital Tuebingen, Tuebingen, Baden-Württemberg, Germany
Dept. of Dermatology, University of Frankfurt, Frankfurt, Hessen, Germany
Dept. of Dermatology, Medical Center Buxtehude, Buxtehude, Niedersachsen, Germany
Dept. of Dermatology, Hildesheim, Hildesheim, Niedersachsen, Germany
Dept. of. Dermatology, University of Saarland, Homburg, Homburg, Saaland, Germany
Dept. of Dermatology, University Otto von Guericke, Magdeburg, Saxony-Anhalt, Germany
Dept. of Dermatology, University of Schleswig-Holstein, Kiel, Schleswig-Holstein, Germany
Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck, Lübeck, Schleswig-Holstein, Germany
Dept. of Dermatology, Helios Clinic Erfurt, Erfurt, Thuringia, Germany
Dept. of Dermatology, University of Jena, Jena, Thuringia, Germany
Dept. of Dermatology, Charité Berlin, Berlin, , Germany
Dept. of Dermatology, Vivantes Clinics, Berlin, , Germany
Name: Jens Ulrich, MD
Affiliation: Dept. of Dermatology, University Otto von Guericke, Leipziger Strasse 44, D-39120 Magdeburg, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Axel Hauschild, MD
Affiliation: Dept. of Dermatology, University of Kiel, Schittenhelmstrasse 5, D-24105 Kiel, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Peter Mohr, MD
Affiliation: Dept. of Dermatology, Medical Center Buxtehude, Krankenhausstrasse 1, D-21614 Buxtehude, Germany
Role: STUDY_DIRECTOR