The study protocol is being conducted to compare intermittent high-dose i.v. administation of interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis free survival (DMFI) as a primary endpoint.
Arm A: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v followed by 48 weeks of treatment with 3 x 10 MIU/m2 s.c Arm B: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v repeated 3 times with 12 treatment-free-weeks between the cycles Secondary endpoints: Improved overall survival rate, Assess side effects of therapy in both treatment arms, Assess time spent on sick leave, Assess number of treatment-related days in hospital, Assess overall performance status, Assess blood MX protein levels
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Universitätshautklinik ,St.Josef- Hospital
Bochum, Germany
RECRUITINGElbekliniken Buxtehude
Buxtehude, Germany
RECRUITINGdistant metastasis free survival/(DMFI )
overall survival
time to progression
toxicity
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Universitätshautklinik Köln
Cologne, Germany
RECRUITINGUniversitätshautklinik Essen
Essen, Germany
RECRUITINGUniversitätsklinik Eppendorf
Hamburg, Germany
RECRUITINGPraxis
Hanover, Germany
RECRUITINGUniversitätshautklinik Heidelberg
Heidelberg, Germany
RECRUITINGUniversitätsklinikum des Saarlandes, Hautklinik
Homburg/ Saar, Germany
RECRUITINGChristian- Albrechts- Universität ,Hautklinik
Kiel, Germany
RECRUITINGUniversitätshautklinik Mainz
Mainz, Germany
RECRUITING...and 3 more locations