Biliary Cancer
Conditions
Interventions
Adjuvant chemotherapy with 6 cycles of gemcitabine on days 1, 8, and 15 every 4 weeks
Sponsors
Department of Surgery Graduate School of Medicine Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically verified biliary cancer who had macroscopic complete resection (>=stage II) and no prior radiation or chemotherapy ECOG Performance Status 0-1 Adequate organ function (leukocytes>=4.0 X 109/L, neutrophils>=2.0 X 109/L, platelets>=100 X 109/L, hemoglobin>=9 g/dl, total bilirubin<=2 X upper limit of normal (ULN), AST, ALT<=4 X ULN, serum creatine<=ULN No fever with infection Adverse events other than blood/bone marrow<=grade 2 according to National Cancer Institute - Common Terminology Criteria for Adverse Events v3.0 Written informed consent No major postoperative complication Tolerable to chemotherapy within 12 weeks after surgery
Exclusion criteria
Exclusion criteria: Pulmonary fibrosis or interstitial pneumonia with radiological or clinical findings Uncontrollable pleural effusion Uncontrollable diabetes mellitus or liver dysfunction With distant metastasis except lymph node metastasis With uncured other malignancies Active infection Severe major postoperative complication such as peritonitis and massive bleeding With active peptic ulcer A history of myocardial infarction within 3 months Psychiatric disorder Pregnant or breast-feeding women, Women wishing for baby
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Safety Phase II: Feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Safety | — |
Countries
Japan
Contacts
Public ContactEtsuro Hatano
Graduate School of Medicine Department of Surgery
Outcome results
None listed