Randomized phase II/III study of gemcitabine and nab-paclitaxel therapy versus S-1 and concurrent radiotherapy as neoadjuvant treatment for Borderline resectable pancreatic cancer
Phase 2
Recruiting
- Conditions
- Borderline Resectable Pancreatic Cancer
- Registration Number
- JPRN-UMIN000026858
- Lead Sponsor
- EPOC A1601/JASPAC07
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Not provided
Exclusion Criteria
1. History of gemcitabine, nab-paclitaxel and fluorouracil 2. poor control of diarrhea 3. Use of Coumadin, Phenytoin and Flucytosine 4. Allergic to gemcitabine and nab-paclitaxel 5. Computed tomography contrast media allergy 6. Intestinal pneumonia 7. Moderate amount of ascites or pleural effusion 8. Active infection 9. Poor control of diabetes mellitus 10. Ongoing active other malignancy 11. Active peptic ulcer 12. Serious comorbid conditions 13. Myocardial infarction within last 6 months 14. Systemic steroid therapy 15. Serious psychiatric diseases 16. Planning a baby or pregnancy 17. Planning a baby 18. Judged unable to guarantee safety
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PhaseII part: R0 resection rate PhaseIII part: Overall survival
- Secondary Outcome Measures
Name Time Method PhaseII part: Incidence of adverse events PhaseIII part: Progression free survival, R0 resection rate, 2 year survival rate, Radiological response rate, Histological response rate, Incidence of adverse events, Protocol compliance (completion rate of neoadjuvant therapy and overall therapy)