Advanced nonresectable pancreatic cancer
Conditions
Interventions
Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1, 8 and 15. The cycle was repeated every four weeks until evidence of disease progression, patient refusal or unaccepta
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study is designed to enroll patients with nonresectable, histologically or cytologically proven, locally advanced or metastatic pancreatic adenocarcinoma. Other eligibility criteria includes no prior therapy, Karnofsky Performance Status >= 50%, age between 20 and 80 years, life expectancy more than 2 months, and adequate organ function defined as WBC >=3,000/mm3, neutrophils >=1,500/mm3, platelets >=100,000/mm3, hemoglobin>=9.0g/dl, total bilirubin <=2.0mg/dl (or <=3.0mg/dl if biliary drainage were present), AST and ALT <=2 times the upper limit of normal (or <=5 times the upper limit of normal if liver metastasis were present), and creatinine <= the upper limit of normal. Written informed consent is required from all patients.
Exclusion criteria
Exclusion criteria: The exclusion criteria are as follows: active infection, intestinal pneumoniae or lung fibrosis, severe complication such as liver cirrhosis and heart disease, active concomitant malignancy, pregnant or lactating females, females of childbearing age, sever drug hypersensitivity, and the patient inappropriate for entry onto this study in the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compliance rate of protocol regimen (The rate is the proportion of patients without grade 3 to 4 hematological toxicity or grade 2 to 4 non-hematological toxicity defined by Common Terminology Criteria for Adverse Events (CTCAE) ver3.0, within eight weeks after initiation of chemotherapy. ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose intensity 1 year survival rate Median survival time Response Rate Time to progression Time to treatment failure Karnofsky - perfomance status Adverse effects | — |
Countries
Japan
Outcome results
None listed