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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00602745

Acronym

S-1 Pancreas

Enrollment

Registered

2008-01-28

Start date

2008-02-29

Completion date

2010-03-31

Last updated

2016-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm Metastasis, Pancreatic Neoplasm

Keywords

pancreatic cancer

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.

Interventions

DRUGS-1

oral administration

DRUG5-Fluorouracil

intravenous bolus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas * Metastatic disease previously treated with a gemcitabine-based regimen

Exclusion criteria

* Locally advanced disease * More than one prior chemotherapy-line for advanced pancreatic disease * Prior treatment with fluoropyrimidines for advanced pancreatic cancer * Eastern Cooperative Oncology Group (ECOG) performance status \>or= 2 * Poor kidney, liver or bone marrow functions * Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study * Unable to swallow capsules * Hypersensitivity history to any of the constituents of the study medications or fluoropyrimidines * Concurrent participation in another clinical trial or treatment with any other anticancer therapy The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Design outcomes

Primary

Measure	Time frame
Overall Survival	study period

Secondary

Measure	Time frame
Progression Free Survival	every 6 weeks
Overall Response Rate according to RECIST criteria	every 6 weeks
Clinical Benefit assessed by Time to Symptoms Worsening (TTSW)	every 6 weeks

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026