Resectable Biliary Tract Cancers
Conditions
Interventions
3 cycles of neoadjuvant chemothrapy with biweekly gemcitabine, cisplatin, and S-1.
6 cycles of neoadjuvant chemothrapy with biweekly gemcitabine, cisplatin, and S-1.
Sponsors
KHBO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Resectable biliary tract cancer (BTC) 2) Age >= 20 y/o 3) PS 0 or 1 4) No prior treatment for BTC except for drainage 5) Proper organ function (1) Neutrophil >= 1500/uL (2) Platelet >= 100,000/uL (3) Hb >= 9.0 g/dL (4) AST and ALT <= 150 U/L (5) Bilirubin <= 1.5 mg/dL (6) Creatinin <= 1.2 mg/dL (7) Creatinin clearance >= 60 6) Oral intake 7) Appropriate for neoadjuvant chemotherapy in each hospital 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Distant metastasis 2) Double cancer 3) Interstitial pneumonia 4) Waterly diarrhea 5) Active infection except for hepatitis and cholangitis 6) Several organ dysfunction (Heat failure, Renal failure, Liver failure, GI bleeding, Ileus, Uncontrolled DM) 7) Pregnancy 8) Psychic disorder 9) Allergy 10) Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Resection rate, Recurrence-free survival, Overall survival, Anti-tumor effect, Completion rate, Dose intensity, Adverse effect, Rate of LN metastasis | — |
Countries
Japan
Contacts
Public ContactTatsuya Ioka
KHBO Osaka International Cancer Institute
Outcome results
None listed