Unresectable or recurrent bilary tract cancer
Conditions
Interventions
A: Chemotherapy with gemcitabine (1,000 mg/m2/day, day 1,8) and cisplatin (25 mg/m2/day, day 1,8) repeated every 3 weeks
B: Chemotherapy with gemcitabine (1,000 mg/m2/day, day 1,8) and S-1 (60 mg-100m
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as biliary tract cancer (carcinoma of the intrahepatic bile duct (IHBD), extrahepatic bile duct (EHBD), gallbladder (GB), and ampulla of Vater (AV)) 2) Histologically proven adenocarcinoma or adenosquamous carcinoma for patients with EHBD, GB, or AV carcinomas, or adenocarcinoma for IHBD carcinomas 3) Unresectable or recurrent cancer 4) Aged 20 to 79 years old 5) ECOG performance status of 0 or 1 6) Measurable region is not required 7) No previous treatment except surgery and biliary drinage for biliary tract cancer. 8) No previous chemotherapy or radiotherapy for other malignancies. 9) Absence of central nervous system metastasis 10) Absence of moderate or severe ascites and/or pleural effusion 11) Oral intake is possible 12) Absense of watery diarrehea 13) Grade1or less of peripheral sensory neuropathy, peripheral motor neuropathy and tinnitus 14) Adequate organ functions 15) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Pregnant or lactating women or women of childbearing potential, Male expecting partner's pregnancy 4) Psychiatric disease 5) Patients requiring systemic steroids medication 6) Interstitial pneumonia, pulmonary fibrosis 7) Serious co-existing illness 8) Unstable angina pectoris within 3 weeks, or with a history of myocardial infarction within 6 months 9) Patients requiring flucytosine, phenytoin or warfarin 10) Impossible to use both iodine and gadolinium due to being allergic to contrast agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Adverse events, Serious adverse events, Clinically-significant adverse events, Response rate, %Planned dose | — |
Countries
Japan
Contacts
Public ContactChigusa Morizane
JCOG1113 Coordinating Office National Cancer Center, Tokyo Hepatobiliary and Pancreatic Medical Oncology
Outcome results
None listed