Randomiszd phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 in patients with resected pancreatic cancer
- Conditions
- Resected pancreatic cancer
- Registration Number
- JPRN-UMIN000000655
- Lead Sponsor
- Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 360
Not provided
Exclusion criteria are as folllows: 1) Prior history of gemcitabine therapy or S-1 therapy 2) Recurrent disease on enrollment 3) Massive ascites or pleural effusion 4) Plumonary fibrosis or interstitial pneumonia 5) Severe diarrhea 6) NYHA III or IV cardiac function 7) Myocardial infarction within six months 8) Severe infection 9) Severe diabetes 10) Blood transfusion within two weeks 11) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc 12) Severe mental disorder 13) Severe drug allergy 14) Other active malignancy 15) Pregnancy, breast feeding, or women who desire to preserve fecundity 16) Men who desire to have children 17) Regular use of frucitocin, fenitoin or warfarin 18) 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 Incidence of adverse events Relapse-free survival Health-related quality of life