Primary objective: to evaluate whether the addition of sunitinib prolongates the Progression-Free Survival (PFS) in patients with advanced pancreatic cancer receiving first-line gemcitabine chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Gemcitabine 1.000 mg/m2, d1,8q3weeks Sunitinib 50 mg/day (2weeks on/1weeks off)
1.000 mg/m2 d1,8,15q4weeks
Städtisches Klinikum Braunschweig
Braunschweig, Germany
Universitätsklinikum Essen
Essen, Germany
Krankenhaus
Frankfurt, Germany
Time to Progression
Time frame: once all patients completed treatment
Response Rate (RR)
Time frame: once all patients completed treatment
overall survival
Time frame: at study end
Safety
Time frame: at study end
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Klinikum der J. W. Goethe Universität; Zentrum der Inneren Medizin
Frankfurt, Germany
Internistisches Facharztzentrum
Frankfurt, Germany
Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät
Halle, Germany
Facharztpraxis
Heidelberg, Germany
Klinikum Lüdenscheid
Lüdenscheid, Germany
Klinikum Nürnberg Nord
Nuremberg, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Germany
...and 1 more locations