histologically verified biliary tract cancer (BTCs) with macroscopic complete resection
Conditions
Interventions
Sponsors
Shinshu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically verified BTC who had macroscopic complete resection and no prior chemotherapy or radiotherapy (patients who had undergone adjuvant radiotherapy were not excluded if at least 4 weeks had passed since the last administration) were eligible for this study. Other eligibility criteria included as follows: 20 years <= age < 80 years; Eastern Cooperative Oncology Group performance status of 0-2; adequate bone marrow function (leucocyte count >= 4,000/mm3, neutrophil count >= 2,000/mm3, hemoglobin >= 10g/dl, and platelet count >=100,000/mm3), liver function (serum albumin >= 3.0g/dl, total bilirubin <= 2 times the upper limit of normal (ULN) and aspartate aminotransferase [AST]/alanine aminotransferase [ALT] <= 3 times ULN) and renal function (creatinine <= 1.0 mg/dL); life expectancy >= 3 months. All patients provided written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria included contracting active infection, syncronous cancer, pregnancy or lactation, a history of severe drug allergy and other severe comorbid diseases including hemopericardium or symptomatic brain metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival (DFS) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival (OS) rate, tolerability, and the frequency of grade 3 or 4 toxicity. | — |
Countries
Japan
Contacts
Public ContactAkira Kobayashi
Shinshu University Gastroenterological Surgery
Outcome results
None listed