Biliary tract cancer Cholangio/gallblader carcinoma
Conditions
Interventions
Arm A Gemcitabine (1000 mg/m2 iv) + cisplatin (25 mg/m2 iv) every 3 weeks on
day 1 and 8 for 24 weeks followed by observation
Arm B capecitabine (1250mg/m2 oral) day1-14 every 3 weeks
Arm A&B followe
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Eligibility criteria for enrolment phase 1. Suspicion of or histologically/cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) scheduled for radical surgical therapy 2. Written informed consent 3. No prior chemotherapy for biliary tract cancer 4. No previous malignancy within 3 years or concomitant malignancy, except: nonmelanomatous skin cancer or adequately treated in situ cervical cancer 5. No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmia) 6. Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent 7. No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial 8. Fertile women (18 years 5. Adequate hematologic function: ANC >= 1.5 x 109/L, platelets >= 100 x109/L,hemoglobin >= 9 g/dl or >= 5.59 mmol/L 6. Adequate liver function as measured by serum transaminases (AST and ALT) = 60 mL/min (MDRD) 8. No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy 9. No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization 10. Negative serum pregnancy test within 7 days of starting study treatment in premenopausal women and women
Exclusion criteria
Exclusion criteria: n.a.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival (DFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Disease free survival rate at 24 months - Recurrence free survival - Overall survival (OS) - Safety and tolerability of adjuvant chemotherapy - Quality of life (QoL) - Function of biliodigestive anastomosis - Rate and severity of biliary tract infections - Patterns of disease recurrence - Locoregional control | — |
Countries
Netherlands
Outcome results
None listed