Biliary tract cancer
Conditions
Interventions
S-1: 80 mg/m2 (Day 1-7) GEM: dose escalation (Day 1) CDDP: 30 mg/m2 (Day 1) Every 2 weeks
Sponsors
Tsukuba University Hospital, Division of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with pathologically proved biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer 2.No prior history of chemotherapy. Patient who has undergone adjuvant chemotherapy are eligible if at least 6 months has passed since the last administration. 3.Performance Status (ECOG): 0-2 4.Survival is expected over 3 months 5.Adequate organ function 6.Age >= 20 years 7.Provided written informed consent 8.Measurable or evaluable lesion
Exclusion criteria
Exclusion criteria: 1.With a history of severe drug allergy 2.Active infection 3.Sever complication 4.With uncontrollable diabetes mellitus (HbA1C >=8.0%) 5.With steroid 6.With interstitial pneumonia or pulmonary fibrosis 7.With severe pleural effusion or ascites 8.Active double cancer 9.Patients who are pregnant or lactating, or have an intention to get pregnant 10.Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity, maximum tolerated dose, toxicity, relative dose intensity, tumor response, progression-free survival, and overall survival | — |
Countries
Japan
Contacts
Public ContactToshikazu Moriwaki
Tsukuba University Hospital Divison of Gastroenterology
Outcome results
None listed