Phase II study of alternate-day administrations of S-1 as 2nd-line treatment in patients with metastatic and locally advanced pancreatic cancer
Phase 2
- Conditions
- Metastatic or locally advanced pancreatic cancer
- Registration Number
- JPRN-UMIN000003454
- Lead Sponsor
- Pancreatic Cancer Treatment Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1)Symptomatic pulmonary fibrosis or interstitial pneumonia 2)Severe diarrhea 3)Active infection 4)Severe complications, such as ileus, heart failure and renal failure 5)Marked pleural or peritoneal effusion 6)Metastasis in central nervous system 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)History of severe anaphylaxies 12)Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method Time to Treatment Failure, Disease Control Rate, Adverse Events, Administration Rate of S-1