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Phase II study of 3-weeks cycle of S-1 as first-line for advanced pancreatic cancer (PACS-3)

Phase 2
Conditions
advanced pancreatic cancer
Registration Number
JPRN-UMIN000011179
Lead Sponsor
Gifu University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
70
Inclusion Criteria

Not provided

Exclusion Criteria

1) Pulmonary fibrosis or interstitial pneumonia. 2) Watery diarrhoea. 3) Active infections, excluding viral hepatitis. 4) Serious complications (e.g. heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes). 5) Moderate or severe ascites or pleural effusion requiring treatment. 6) Metastasis in the CNS. 7) Active double cancer. 8) Patients under treatment with flucytosine, phenytoin or warfarin potassium. 9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 10) Severe mental disorder. 11) Judged ineligible by physicians for participation in the study from a safety viewpoint.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall survival
Secondary Outcome Measures
NameTimeMethod
Progression free survival Response rate Safety
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