Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer (YCOG001)
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-UMIN000003658
- Lead Sponsor
- kanagawa cancer center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 66
Not provided
1.With moderate or more ascites/pleural effusion 2.Plumonary fibrosis or interstitial pneumonia 3.Cardiac insufficiency or myocardial infarction within six months 4.Active bacterial or fungous infection 5.Uncontrollable diabetes mellitus 6.Psychosis or severe mental disorder 7.Severe drug allergy 8.Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy 9.Previous chemotherapy or radiotherapy against any other malignancies within 3 years 10.Gemcitabine chemotherapy but with the permission over 6 months after adjuvant chemotherapy 11.Previous therapy against pancreatic cancer 12.With CNS metastasis 13.Pregnant, lactating women or women of childbearing potential 14.Men who want to get partner pregnant 15.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 (1-year survival)
- Secondary Outcome Measures
Name Time Method progression-free survival, response rate, adverse events, severe, QOL evaluation, body weight, performance status.