Biliary tract cancer
Conditions
Interventions
S-1 adjuvant chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily for 1 year. The 1 course of TS-1 therapy is consist of 28 days administration followed by 14 days rest accord
Sponsors
Keio University School of Medicin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer which histologically confirmed adenocarcinoma 2) patients with Stage IB~III biliary tract cancer which is curatively resected(R0 or R1) 3)with no distant metastasis, cancerous ascites 4)age: >=20 5)ECOG P.S. 0-1 6) no prior treatment for biliary tract cancer except operation 7) No postoperative complications and possible to start treatment within 10 weeks from operation 8) sufficient function of important organs WBC: >=3,000/mm3 and <=12,000/mm3 Neut:>=2000/mm3 Platelet: >=100,000/mm3 Hem: >=9.0g/dl Alb:>=3.0g/dL AST, ALT: <= 100IU/l((or 150U/L if biliary drainage were present) sT.bil: <=2.0mg/dl serum Cr: <=1.2mg/dL Ccr: >=60 ml/min/body 9) oral intake 10)no abnormal finding by cardiac electrogram within 28 days 11)written informed consent
Exclusion criteria
Exclusion criteria: 1) with history of TS-1 administration 2)with interstitial pneumonia or pulmonary fibrosis within 28 days before accrual 3)with diarrhea 4)with clinically important infection 5)blood infusion within 14 days before accrual 6)sever complication(Heart failure, renal failure, liver failure, Hemorrhagic peptic ulcer, Intestinal paralysis, Ileus, uncontrollable diabetes mellitus etc) 7)more than moderate degree of Ascitic fluid and Pleural effusion 8)has active carcinoma except carcinoma in situ 9)administered flucytosine, Phenytoin, Warfarin potassium 10) pregnant women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant 11) known sever drug allergies 12) sever mental disorder 13) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completed rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative dose intensity Adverse events Disease free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactOsamu Itano
Department of Surgery, Keio University School of Medicine Department of Surgery
Outcome results
None listed