Birialy tract cancer
Conditions
Interventions
Gemcitabine is i.v. administered at a dose of 1000 mg/m2 for 30 min on days 1,8 of each 21-day cycle. Cisplatin is i.v. administered at a dose of 25 mg/m2 for 120 min on days 1,8 of each 21-day cycl
1.25 m2 80 mg/day 1.25-1.5 m2 100 mg/day >
=1.5 m2 120 mg/day
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 treatments, 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, Response rate, Disease control rate, one-year survival rate, Tumor marker | — |
Countries
Japan
Contacts
Public ContactTadashi Uwagawa
Jikei University school of Medicine Department of surgery, Division of hepatobiliary pancreatic surgery
Outcome results
None listed