Spots Global Cancer Trial Database for S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen
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Trial Identification
Brief Title: S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen
Official Title: A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen
Study ID: NCT00602745
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office, Vienna, , Austria
Sanofi-Aventis Administrative Office, Sao Paulo, , Brazil
Sanofi-Aventis Administrative Office, Laval, , Canada
Sanofi-Aventis Administrative Office, San José, , Costa Rica
Sanofi-Aventis Administrative Office, Horsholm, , Denmark
Sanofi-Aventis Administrative Office, Paris, , France
Sanofi-Aventis Administrative Office, Athens, , Greece
Sanofi-Aventis Administrative Office, Mixco, , Guatemala
Sanofi-Aventis Administrative Office, Budapest, , Hungary
Sanofi-Aventis Administrative Office, Netanya, , Israel
Sanofi-Aventis Administrative Office, Ocean Business Plaza, , Panama
Sanofi-Aventis Administrative Office, Lima, , Peru
Sanofi-Aventis Administrative Office, Bucuresti, , Romania
Sanofi-Aventis Administrative Office, Midrand, , South Africa
Sanofi-Aventis Administrative Office, Bromma, , Sweden
Sanofi-Aventis Administrative Office, Megrine, , Tunisia
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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