The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer.
Phase 2
Recruiting
- Conditions
- Pancreatic ductal adenocarcinoma
- Registration Number
- JPRN-UMIN000030717
- Lead Sponsor
- Department of gastrointestinal Surgery, Hiroshima University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1.Severe allergy for protcol drugs 2.Histly of active malignant disease within 5 years 3. Active infectious disease 4. >Geade2 of neuropahty 5. Ileus 6. Active interstitional pneumonia 7. Uncontrolable ascites and pleural effusion 8.Uncontrolable diabetes 9.Uncontrolable heart diseases 10.Histry of sevese neurological sidease 11.Pregnancy or possibility of pregnancy 12.Others who were judged to be not appropriate for participation to this clinicalrial by attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Over all survival after initiation of protocol therapy and median survival time
- Secondary Outcome Measures
Name Time Method -Disease free survival after initiation of protocol therapy -Adverse events -postoperative complication with more than grade 3 -Response rate and normalization rate of tumormarkers after neoadjuvant chemotherapy -Histological responce (Evans grade) -Curative resection rate -Short time outcomes after surgical resection -Reoperation rate, readmission rate and mortality -Initiation and completion rate of adjuvant chemotherapy -Dose intensity