A Randomized Phase II Study of Dose Schedule of TS-1 for Metastatic/Advanced Pancreatic Cancer
- Conditions
- Metastatic/Locally Advanced Pancreatic Cancer
- Registration Number
- JPRN-UMIN000008604
- Lead Sponsor
- Wakayama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 190
Not provided
(1) Interstitial pneumonia or pulmonary fibrosis. (2) Watery diarrhea. (3) Severe infections (without viral hepatitis) or being suspected (fever evaluation >=38 degrees). (4) Serious complication (heart failure, renal disorder, liver disorder, bleeding digestive ulcer, intestinal tract paralysis, and etc. ). (5) Moderate or greater pleural effusion, ascites fluid (requiring drainage). (6) Cerebral metastasis. (7) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 3 year) except carcinoma in situ or intramucosal cancer. (8) Patients who require administration of flucytosine, phenytoin, and warfarin. (9) Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period. (10) Serious mental disorder. (11) Drug hypersensitivity. (12) Patients who are judged by doctors inappropriate to perform the study safely.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method QOL(EQ-5D,EORTC-C30), progression-free survival, PFS, time to treatment failure, TTF,response rate, RR, Adverse Event