A Randomised Phase II trial investigating the duration of adjuvant therapy(6 versus 12 months) with S-1 for patients after resection of pancreatic cancer
- Conditions
- Resected pancreatic cancer
- Registration Number
- JPRN-UMIN000012634
- Lead Sponsor
- Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 170
Not provided
1) Previously treated by chemotherapy for locally advanced pancreatic cancer 2) Prior history of S-1 therapy 3) History of serious drug hypersensitivity or a history of drug allergy 4) Patients with contraindication for the medication of S-1 5) Serious complications ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, intractable diabetes, intractable hypertension) 6) Recurrent disease before enrollment 7) Moderate or ascites or pleural effusion 8) Plumonary fibrosis or interstitial pneumonia diagnosed by chest X-ray. 9) Serious diarrhea 10) Myocardial infarction within six months 11) Active infection(fever up; over 38 degree) 12) Blood transfusion within 2 weeks before enrollment 13) Severe mental disorder 14) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free survival of 5 years or less). 15) Pregnant or lactating woman and man who hope for partner's pregnancy 16) Patients who need flucytosine, phenytoin or warfarin potassium. 17) Requiring continous steroid administration 18) Not appropriate for the study at the physician's assessment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year overall survival rate
- Secondary Outcome Measures
Name Time Method DFS, OS, Dose Intensity, Complete rate of each treatment point (3 and 6, 9, 12 months), Safety