NCT00602745

S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Neoplasm
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	S-1	oral administration
DRUG	5-Fluorouracil	intravenous bolus

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-01-28
• Last updated: 2016-05-26

Locations

17 sites across 17 countries: United States, Austria, Brazil, Canada, Costa Rica, Denmark, France, Greece, Guatemala, Hungary, Israel, Panama, Peru, Romania, South Africa, Sweden, Tunisia