Unresectable advanced pancreatic cancer
Conditions
Interventions
Gemcitabine is i.v. administered at a fixed dose of 1000 mg/m2 for 30 min on days 1 and 8, every 3 weeks. CDDP is i.v. administered at a fixed dose of 25 mg/m2 on days 1 and 8, every 3 weeks. S-1 i
Sponsors
Jikei University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patients with inoperable advanced biliary tract cancer including intrahepatic cholangiocarcinoma and ampullary carcinoma diagnosed by pathologically methods or graphically visualizes examination Patients with post-operative recurrent is excluded) 2) Patients of age =>20 and 80> 3) Patientswith Eastern Chemotherapy Oncology Group (ECOG) performance status of 0,1 4) Life expectancy more than 3 months 5) Hemoglobin >=9.0g/dl, WBC>=3,000/mm3,12,000/mm3, neutrophils >=1,500/mm3, platelets >=100,000/mm3, AST/ALT </=100, 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 other treatment, such as radiation or chemotherapy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival, PFS, Disease control rate, one-year survival rate | — |
Countries
Japan
Contacts
Public ContactTadashi Uwagawa
Jikei University School of Medicine Department of surgery, Division of hepatobiliary pancreatic surgery
Outcome results
None listed