Biliary tract cancer
Conditions
Interventions
GEM+CDDP neoadjuvant chemotherapy is conducted. GEM 1000mg/m2/day and CDDP 25mg/m2/day are intravenously administered on day 1, 8, 22, and 29. S-1 adjuvant chemotherapy is conducted. S-1 80mg/m2/day
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. presence of histological or cytological confirmed (adenocarcinoma or adenosquamous carcinoma), or clinically suspected biliary (intrahepatic, hilar/perihilar, or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary cancer) 2. Stage II, III, or IVa biliary tract cancer in the seventh edition of UICC/AJCC staging system 3. with no prior chemotherapy or radiation to biliary tract cancer 4. evaluable lesion was confirmed with imaging studies within 28 day before registration 5. age>=20 years 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 7. adequate oral intake 8. adequate bone marrow function White blood cells (WBC)>=3,500/mm3 Neutrophils>=2,000/mm3 Platelet>=100,000/mm3 Hemoglobin>=9.0g/dL AST<=100IU/L (or 150IU/L under biliary drainage) ALT<=100IU/L (or 150IU/L under biliary drainage) serum total bilirubin<=2.0mg/dL (or <=3.0mg/dL under biliary drainage) serum creatinine<=upper limit of normal range Alb>=3.0g/dL 9. no abnormal findings by cardiac electrogram within 28 days before registration 10. written informed consent
Exclusion criteria
Exclusion criteria: 1. presence of active double cancer, excluding carcinoma in situ and mucosal carcinoma 2. presence of active infection requiring systemic therapy, excluding viral hepatitis presence of other cancer except carcinoma in situ 3. accumulated pleural effusion or ascites confirmed in chest CT 4. presence of fever more than 38 degrees Celcius at registration 5. women who are pregnant or during the nursing, women who may be pregnant or are willing to get pregnant, or men who are willing to make thier partner pregnant 6. severe mental disorder 7. uncontrollable diabetes mellitus 8. uncontrollable hypertention 9. history of new-onset unstable angina within 3 weeks, progressive angina, or new-onset myocardial infarction within 6 months before registration 10. presence of severe organ dysfunction including postoperative complication (such as heart failure, renal failure, liver failure, and intestinal paralysis) 11. history of severe drug allegy 12. administered flucytosine, phenytoin, or warfarin potassium 13. uncontrollable diarrhea 14. unsuitable candidate to this study judged by a doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completed rate | — |
Countries
Japan
Contacts
Public ContactOsamu Itano
Department of Surgery, Keio University School of Medicine Department of Surgery
Outcome results
None listed