Biliary tract cancer
Conditions
Interventions
FOFIRINOX which is a combination chemotherapy of oxaliplatin, irinotecan, leucovorin, and fluorouracil will be given every 2 weeks.
Sponsors
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) unresectable or recurrent biliary tract cancer 2) histologically or cytologically confirmed adenocarcinoma 3) no prior chemotherapy or radiation therapy 4) age of 20-75 years 5) an Eastern Cooperative Oncology Group PS of 0 or 1 6) at least one measurable lesion 7) adequate hematological, liver, and renal function (white blood cell count=> 10 000/mm3, neutrophil count=>2000/mm3, hemoglobin=>9.0 g/dL, platelet count=>100 000/mm3, aspartate transaminase and alanine transaminase <=2.5x upper limit of normal, total bilirubin <=1.2x upper limit of normal, Creatinine clearance =>50 ml/min). 8) written informed consent
Exclusion criteria
Exclusion criteria: 1) synchronous or metachronous double cancer, excluding carcinoma in situ or intramucosal carcinoma cured by local treatment 2) allergy for contrast medium for CT and MRI 3) brain metastasis 4) blood transfusion, blood products, or hematopoietic growth factor preparations such as G-CSF within 7 days before enrollment 5) UGT genetic polymorphisms of homozygous UGT1A1*28 or UGT1A1*6 or heterozygous UGT1A1*6 and UGT1A1*28 6) apparent coelomic fluid (pleural effusion, ascites, or pericardial fluid) 7) serious concomitant diseases 8) abnormal findings in ECG 9) intestinal pneumonia 10) poorly controlled diabetes 11) diarrhea including watery stools within 3 days before enrollment 12) grade 2 or higher peripheral sensory neuropathy 13) active infection other than HBV or HCV 14) serious allergy 15) history of severe drug allergy 16) pregnant or lactating woman 17) disqualified for trial by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, disease control rate, overall survival, and safety | — |
Countries
Japan
Contacts
Public ContactNaminatsu Takahara
The University of Tokyo Department of Gastroenterology, Graduate School of Medicine,
Outcome results
None listed