JPRN-UMIN000011806
Completed
Phase 2
Randomized phase II study of Gemcitabine and S-1 combination therapy versus S-1 in patients with Gemcitabine-refractory unresectable advanced Pancreatic Cancer - Randomized phase II study of GS vs. S-1 in patients with Gem-refractory unresectable advanced Pancreatic Cancer
Osaka Pancreas Forum0 sites49 target enrollmentSeptember 19, 2013
Conditionsunresectable advanced Pancreatic Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- unresectable advanced Pancreatic Cancer
- Sponsor
- Osaka Pancreas Forum
- Enrollment
- 49
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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