Phase II clinical trial of Gemcitabine and Nab-Pacritaxel combined therapy for pancreatic cancer with the difficulty of curative resectio
Phase 2
Recruiting
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-UMIN000021305
- Lead Sponsor
- Department of Surgery, Tohoku University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
(1) not diagnosed as pancreatic duct adenocarcinoma (2) recurrence (3) obvious distant metastasis (4) with prior anticancer therapy for pancreatic cancer (5) with other active cancer (6) with uncontrollable infection (7) with hypersensitivity for pacritaxel or albmin (8) pregnancy, postpartum within 28 days or lactating (9) expected survival within 6 months (10) difficult for out patient chemotherapy (11) age < 20 (12) without judgement (13) determined to be inappropriate as a subject
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival at 2-year after registration
- Secondary Outcome Measures
Name Time Method All the registration cases -The rate of adverse events -The rate of resolution of curative resection difficulty -The rate of intention for curative resection -The rate of primary tumor resection -Overall survival -Chantes in tumor marker -Tumor shrinkage All the resection cases -The rate of R0 resection -The rate of Lymph node metastasis -Histological response -Relapse free survival -The type of recurrence