The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
oral administration
intravenous bolus
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Vienna, Austria
Overall Survival
Time frame: study period
Progression Free Survival
Time frame: every 6 weeks
Overall Response Rate according to RECIST criteria
Time frame: every 6 weeks
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)
Time frame: every 6 weeks
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