Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.
Phase 2
- Conditions
- Invasive ductal adenocarcinoma
- Registration Number
- JPRN-UMIN000028101
- Lead Sponsor
- Division of Hepato-biliary-pancreatic Surgery Department of Surgery, Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1. History of gemcitabine, nab-paclitaxel 2. Ongoing active other malignancy 3. Allergic to gemcitabine and nab- 4. Computed tomography contrast media allergy 5. poor control of diarrhea 6. Intestinal pneumonia 7. Moderate amount of ascites or pleural effusion 8. Active infection 9. Poor control of diabetes mellitus 10. Serious comorbid conditions 11.Myocardial infarction within last 6 months 12. Systemic steroid therapy 13. Serious psychiatric diseases 14. Planning a baby or pregnancy 15. Planning a baby 16. Judged unable to guarantee safety
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2 year progression-free survival rate (the initial date in reckoning is set at the date of registration)
- Secondary Outcome Measures
Name Time Method Overall survival from registration Radiological response rate R0 resection rate Histological response rate Protocol compliance Relative dose intensity Incidence of adverse events