Randomized phase II study of Gemcitabine and S-1 combination therapy versus S-1 in patients with Gemcitabine-refractory unresectable advanced Pancreatic Cancer
- Conditions
- unresectable advanced Pancreatic Cancer
- Registration Number
- JPRN-UMIN000011806
- Lead Sponsor
- Osaka Pancreas Forum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 49
Not provided
1)Patients who have previously administered 5-FU including S-1 2)Severe complications 3)Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 4)Severe Gem hypersensitivity 5)Patients who have not undergone radiotherapy 6)Active infections 7)Patients with HBs antigen-positive or with HCV antibody-positive 8)Patients who have previous history of radiotherapy to the chest 9)Uncontrollable watery diarrhea 10)Presence of metastasis in central nervous system 11)Severe mental disorders 12)Pregnant or lactating women, or women with known or suspected pregnancy and men who want let to pregnancy 13)Required to continue to take flucytosine, phenytoin, and warfarin 14)Patients seems inadequate for this study by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Overall survival, Disease Control Rate, Response Rate, Relative Dose Intensity, Adverse Events, Time to Treatment failure