Patients with resectable intra- or extrahepatic biliary tract carcinomas. MedDRA version: 17.0 Level: LLT Classification code 10025734 Term: Malignant neoplasm of biliary tract, part unspecified System Organ Class: 100000004864 MedDRA version: 17.0 Level: LLT Classification code 10028982 Term: Neoplasm biliary tract System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Cisplatin ”Accord”
Product Name: Cisplatin "Accord"
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cisplatin
Other descriptive name: CISPLATIN
Concentratio
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Biliary tract carcinoma - cytologically or histologically verified or clinical/radiologically - BTC which is considered to be resectable by the treating surgeon i.e. T1-3N0-1M0. The patient must be evaluated at the local HBP-MDT conference - The patient is operable (i.e. no co-morbidity which can preclude anaesthesia or sur-gery) - WHO performance status 0-1 - Age = 18 years - Adequate haematological, renal, and hepatic function: WBC > 3.0 x 109/l, platelets > 100 x 109/l, creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - No sign of M1 disease - No prior radiotherapy to abdominal cavity - No pregnancy or breast-feeding. Fertile patients must use adequate contraceptives - No sign of other severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months) - No prior chemotherapy for BTC - No prior chemotherapy or other oncologic therapy within 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall and long term objectives are to improve outcome for patients with BTC – carcinomas of the gallbladder, intrahepatic, perihilar, or distal bile ducts. ;Secondary Objective: Not applicable;Primary end point(s): Primary objective is 2 year survival for all patients starting chemotherapy;Timepoint(s) of evaluation of this end point: 5-7 years after last treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Surgical morbidity and mortality - Number of patients with progression during chemotherapy - Number of patients with R0 resection - Acute and late toxicity - Search for predictive factors (tumour-markers);Timepoint(s) of evaluation of this end point: 10-15 years after last treatment | — |
Countries
Denmark, Sweden
Contacts
Public ContactResearch Dept. of Clinical Oncology
Odense University Hospital
Outcome results
None listed