Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in patients with gemcitabine-refractory advanced pancreatic cancer

Phase 2

Recruiting

• Conditions: advanced pancreatic cancer

• Registration Number: JPRN-UMIN000007173
• Lead Sponsor: Tokai University Hospital Kanagawa Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-01
• Study Completion: 2015-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

1)With moderate or more pleural effusion/ ascites 2)Interstitial pneumonia or fibroid lung 3)Cardiac insufficiency or myocardial infarction within six months 4)Active bacterial or fungous infection 5)Uncontrollable diabetes mellitus 6)Psychosis or severe mental disorder 7)Severe drug allergy 8)Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy 9) Previous chemotherapy or radiotherapy against any other malignancies within 3 years 10)Over 6 months after adjuvant gemcitabine chemotherapy 11)With CNS metastas 12)Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 13)Pregnant, lactating women or women of childbearing potential 14)Men who want to get partner pregnant 15)Inadequate physical condition, as diagnosed by primary physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival

Secondary Outcome Measures

Name	Time	Method
response rate, overall survival, adverse events