Adenocarcinoma of pancreas after curative resection
Conditions
Interventions
Gemcitabine was i.v. administered at a fixed dose of 1000 mg/m2 for 30 min on days 1, 8 and 15, every 4 weeks for six cycles. Nafamostat mesilate is administered via a port-catheter system for 24 h
Sponsors
Jikei University school of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients of age =>20 and 80> 2)Patients with gross complete (R0 or R1) resection of adenocarcinoma of pancreas 3)Tolerable to chemotherapy within 8 weeks after surgery 4)Karnofsky performance status =>70% 5)Hemoglobin >=9.0g/dl, WBC>=3,000/mm3,12,000/mm3, Neutrophils >=1,500/mm3, Platelets >=100,000/mm3, AST/ALT </=2.5 x ULN, Total bilirubin </=2.0 x ULN, Serum creatinine </=1.0 x ULN, BUN </=1.0 x ULN, PaO2 >= 70 torr Creatinine clearance>=60 ml/min 6)No replaced common hepatic artery, gastroduodenal artery and celiac artery 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Pulmonary fibrosis or interstitial pneumonia detectable on chest X-ray 2)Active infection 3)Uncontrollable heart disease and myocardial infarction within 6 months 4)Uncontrollable DM 5)Pregnant or lactation women, or women with known or suspected pregnancy 6)History of severe drug allergy 7)Active synchronous or metachronous malignancy 8)Severe complications after operation 9)No chemotherapy or radiotherapy for pancreatic cancer in the past 10)Patients who are judged inappropriate for the entry into the study by the investigater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Free survival one-year and three-year survival rate incidence rate of adverse events | — |
Countries
Japan
Contacts
Public ContactTadashi Uwagawa
Jikei University school of Medicine Department of surgery, Division of hepatobiliary pancreas surgery
Outcome results
None listed