Borderline resectable pancreatic cancer
Conditions
Interventions
Administration of neoadjuvant GEM+nab-PTX
Sponsors
Kyorin University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as pancreatic cancer by imaging and histologically proven adenocarcinoma 2) No distant metastasis 3) Borderline resectable pancreatic cancer by NCCN Guidelines Version 2.2015 4) Without ascites/pleural effusion 5) Measurable disease not mandatory 6) Eastern Cooperative Oncology Group performance status 0-1 7) Peripheral neuropathy (Grade0 or 1) 8) No prior therapy for malignancy 9) Adequate organ function 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) With pulmonary fibrosis or interstitial pneumonia 2) With active double cancers 3) With severe complications such as heart failure, bowel obstruction and uncontrollable diabetes millitus 4) With active infection 5) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 6) Psychosis or severe mental disorder 7) Recieving systemic steroid therapy 8) With severe drug allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility for 2 cycles of GEM+nab-PTX therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate, Response rate, Histological effect, Adverse events, Severe adverse events, Treatment-related death | — |
Countries
Japan
Contacts
Public ContactNaohiro Okano
Kyorin University, School of Medicine Department of Medical Oncology
Outcome results
None listed