pancreatic cancer or biliary tract cancer
Conditions
Interventions
S-1 adjuvant chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily every monday, wednesday,friday and sunday for 1 year.
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: <pancreatic cancer> 1)pancreatic cancer which is curatively resected(R0 or R1) 2)patients without Stage IVb pancreatic cancer <biliary tract cancer> 1)intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer which is curatively resected(R0 or R1) 2)patients without Stage Ia nor Stage IVb biliary tract cancer <pancreatic cancer and biliary tract cancer> 3)with no distant metastasis, cancerous ascites 4)age: >=20 5)No postoperative complications and possible to start treatment within 12 weeks from operation 6)sufficient function of important organs WBC: >=2,000/mm3 and <=12,000/mm3 Neut:>=1,500/mm3 Platelet: >=75,000/mm3 Hem: >=8.0g/dl sT.bil: <=3.0mg/dl AST, ALT: <= 150IU/L Ccr: >=30 ml/min/body 7) oral intake 8)written informed consent *ECOG P.S.:anything is OK
Exclusion criteria
Exclusion criteria: 1) administration contraindication of TS-1 2)with recurrence before the entry of this study 3)with clinically important infection 4)with sever heart failure 5)with interstitial pneumonia or pulmonary fibrosis 6)with sever complication(Intestinal paralysis, Ileus, uncontrollable diabetes mellitus, Renal failure, Liver failure etc) 7)massive ascites fluid or pleural effusion 8)repetitive blood infusion for gastrointestinal hemorrhage or blood infusion within 14 days before accrual 9)with mental disorder receving treatment or needing treatment 10)has active carcinoma except carcinoma in situ 11) administered Flucytosine, Phenytoin, Warfarin potassium 12)pregnant women or lactating women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant 13) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completed rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Relapse-free survival Adverse events Time to treatment failure | — |
Countries
Japan
Contacts
Public ContactMinoru Kitago
Department of Surgery, Keio University School of Medicine Department of Surgery
Outcome results
None listed