Metastatic pancreatic cancer
Conditions
Interventions
Gemcitabine+S-1
Sponsors
National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proven pancreatic adenocarcinoma or adeno-squamous cell carcinoma, 2)At least one measurable metastatic lesion, 3)Naïve to chemotherapy or radiotherapy (except for IORT), 4)Eastern Cooperative Oncology Group performance status of 0-1, 5)Age between 20 and 74 years, 6)Adequate organ function defined as white blood cell count of >=4,000/mm3 and =2,000/mm3, platelet count of >=100,000/mm3, hemoglobin >=9.0 g/dL, total bilirubin <=2.0 mg/dL (<=3.0 mg/dL if biliary drainage were present), and AST and ALT levels <=150 U/L, serum creatinine <=1.5 mg/dL, 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Pulmonary fibrosis or interstitial pneumonia, 2)Watery diarrhea, 3)Active infection (except for chronic viral hepatitis), 4)Severe complications, such as heart disease, renal failure, hepatic failure, and active gastric ulcer, 5)Marked pleural effusion or ascites, 6)Metastasis to the central nervous system, 7)Active concomitant malignancy, 8)Severe mental disorder, 9) Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event Progression free survival Survival | — |
Countries
Japan
Contacts
Public ContactHideki Ueno, MD, PhD
GS Therapy Coordination Office National Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
Outcome results
None listed