Advanced nonresectable pancreatic cancer
Conditions
Interventions
S-1 40mg/m2 is administered orally twice daily from day 1 to day 14 followed by a two-week rest. Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1 and 15. The cycle was
Sponsors
Faculty of Medicine, University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study is designed to enroll patients with nonresectable, pathologically proven, locally advanced or metastatic pancreatic cancer. Other eligibility criteria includes no prior therapy, performance status of 0-2, age between 20 and 79 years, life expectancy more than 3 months, and adequate organ function defined as white blood cell count >=3,000/mm3;, platelet count>=100,000/mm3;, hemoglobin>=10g/dl, total and direct bilirubin <=2 times the upper limit of normal, AST and ALT <=5 times the upper limit of nomal, and creatinine <=1.5 times the upper limit of normal, creatinine clearance>=50ml/ml. Written informed consent is required from all patients.
Exclusion criteria
Exclusion criteria: The exclusion criteria are as follows: active infection, digestive ulcer or bleeding, stomach or esophageal varices, pregnant or lactating women, women of childbearging age, active concomitant malignancy, severe drug hypersensitivity, and the patient inappropriate for entry onto this study in the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival Overall Survival Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Benefit Response Tumor Marker Adverse effects | — |
Countries
Japan
Contacts
Public ContactHiroyuki Isayama
Faculty of Medicine, University of Tokyo Department of Gastroenterology
Outcome results
None listed