Advanced bile duct cancer
Conditions
Interventions
Group A:Gemcitabine 1,000mg/m2 is administered with 30-min intravenous infusion on day 1, 8, and 15 every 4 weeks.
Group B:TS-1 80mg/m2/day is administered orally for 4 consecutive weeks every 6 week
Sponsors
Osaka International Cancer Institute Department of Hepatobiliary and pancreatic Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with non-resectable bile duct cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer) or recurrent bile duct cancer 2.Histologically or cytologically confirmed adenocarcinoma,squamous cell carcinoma or adeosquamous carcinoma of the bile duct cancer(extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer). Histologically or cytologically confirmed adenocarcinoma of the intrahepatic bile duct cancer. 3.Patients without the prior treatment except surgery and biliary drainage 4.Patients who received adjuvant chemotherapy 6 months or more ago can be registered. 5.Performance Status:0-1(ECOG) 6.Oral intake is possible. 7.Patients of age =>20 and 80> 8.Sufficient organ functions (1)hemoglobin>=10.0g/dl (2)WBC >=3,000/mm3 (3)neutrophils>=1,500/mm3 (4)platelets>=100,000/mm3 (5)AST(GOT)<=100IU (or <=150IU if biliary drainage were present) (6)ALT(GPT)<=100IU (or <=150IU if biliary drainage were present) (7)total bilirubin <=2.0mg/dl,(or <=3.0mg/dl if biliary drainage were present) (8)serum creatinine <= 1.2mg/dl (9)creatinine clearance>=60ml/min 9.Written informed consent
Exclusion criteria
Exclusion criteria: 1.lung fibrosis or intestinal pneumonia 2.Watery diarrhea 3.Severe infection 4.Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) 5.Medical history of serious allergy reactions to any drug 6.Massive pleural or abdominal effusion 7.Metastasis to central nervous system 8.Active synchronous or metachronous malignancy other than carcinoma in situ 9.Regular use of frucitocin, fenitoin or warfarin 10.Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 11.Severe mental illness 12.Patients who are judged inappropriate for the entry into the study by the investigater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival(OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival(PFS) Adverse events QOL Response rate | — |
Countries
Japan
Contacts
Public ContactTatsuya Ioka
Osaka International Cancer Institute Department of Hepatobiliary and pancreatic Oncology
Outcome results
None listed