Randomized phase III study of adjuvant chemotherapy with combination therapy of gemcitabine and S-1 vs. gemcitabine alone in patients with resected pancreatic cancer (JSAP-04)
- Conditions
- Resected pancreatic cancer
- Registration Number
- JPRN-UMIN000004410
- Lead Sponsor
- Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer (JSAP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 300
Not provided
1) History of serious complications related to surgery 2) Patients under treatment with phenytoin, warfarin potassium or flucytosine. 3) Uncontrolled watery diarrhea 4) Sever mental disorder 5) Active infection 6) Serious complications 7) Pulmonary fibrosis or interstitial pneumonia 8) Clinically significant pleural effusions or ascites 9) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 2 years or less) 10) History of chemotherapy or radiotherapy for other malignant disease within one year 11) Unable to receive contrast enhanced CT nor MRI due to allergic reaction to contrast medium 12) Pregnant females, possibly pregnant females, females wishing to become pregnant, and males that are currently attempting to produce a pregnancy 13) 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 Relapse-free survival Incidence of adverse events