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%.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim
Mannheim, Baden-Wurttemberg, Germany
RECRUITINGDept. of Dermatology, University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGDept. of Dermatology, University of Frankfurt
Frankfurt am Main, Hesse, Germany
RECRUITINGDept. of Dermatology, Medical Center Buxtehude
Buxtehude, Lower Saxony, Germany
RECRUITINGDept. of Dermatology, Hildesheim
Hildesheim, Lower Saxony, Germany
RECRUITINGDept. of. Dermatology, University of Saarland, Homburg
Homburg, Saaland, Germany
RECRUITINGDept. of Dermatology, University Otto von Guericke
Magdeburg, Saxony-Anhalt, Germany
RECRUITINGDept. of Dermatology, University of Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
RECRUITINGDept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
RECRUITINGDept. of Dermatology, Charité Berlin
Berlin, State of Berlin, Germany
RECRUITING...and 3 more locations
Overall survival
Quality of life analysis
Objective tumor response rate in study arm B
Time to tumor progression
Cost analysis
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