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eoadjuvant S-1 therapy for resectable pancreatic cancer patients; A phase2 study

Phase 2
Conditions
pancreatic cancer
Registration Number
JPRN-UMIN000013031
Lead Sponsor
Hokkaido Pancreatic Cancer Study Group (HOPS)
Brief Summary

2year disease free survival ITT(N=49):40.8% 2year disease free survival Resection(N=43):46.5% 2year overall survival ITT(N=49):73.2% 2year overall survival Resection(N=43):76.7%

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
51
Inclusion Criteria

Not provided

Exclusion Criteria

1) Treatment history of S-1 2) Treatment history of a pancreatic cancer 3) Regular use of frucitocin, fenitoin or warfarin 4) Patients who can' t receive neither iodic drug because of drug allergy 5) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings 6) Massive pleural or abdominal effusion 7) Severe infection 8) Watery diarrhea 9) Uncontrolled diabetes 10) Simultaneous or metachronous (within 3 years) double cancers 11) Hemorrhagic peptic ulcer 12) Patients with severe disease 13) Patients requiring systemic steroids medication 14) Severe mental illness 15) Severe drug hypersensitivity 16)Pregnant females, possibly pregnant females, females wishing to become pregnant or Males that are currently attempting to produce a pregnancy 17)Patients seems inadequate for this study by investigators

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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