unresectable biliary tract cancer
Conditions
Interventions
GEM/CDDP/S-1 (intervention)
GEM/CDDP (control)
Sponsors
Kansai Hepatobiliary Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with cytologically or histologically proved biliary tract cancer 2. age >=20 years 3. PS 0-2 4. No prior history of chemotherapy or radiotherapy. 5. Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count >=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L), and renal function (creatinine clearance >=45 mL/min) 6.Adequate oral intake 7.Provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with interstitial pneumonia or pulmonary fibrosis 2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe active infection 4. Patients with moderate or marked pleural effusion or ascites necessitating drainage 5. Patients with a history of severe drug allergy 6. Patients with other serious comorbid disease 7. Patients who are pregnant or lactating, or have an intention to get pregnant 8. Patients with mental disease 9. Patients who are judged inappropriate for the entry into the study by the principle doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Countries
Japan
Contacts
Public ContactMASASHI KANAI
Kyoto University Hospital Department of Clinical Oncology and Pharmacogenomics
Outcome results
None listed