Partients who have undergone surgical resection of a biliary tract cancer (including intrahepatic and extrahepatic cholangiocarcinoma, cancer of the distal bile duct and muscle invasive gallbladder cancer).
Conditions
Interventions
Trade Name: xeloda (150 mg)
Product Name: Xeloda (Capecitabine)
Pharmaceutical Form: Film-coated tablet
Trade Name: Xeloda (500 mg)
Product Name: Xeloda (capecitabine)
Pharmaceutical Form: Film-coate
Sponsors
The University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with histologically confirmed biliary tract cancer who have undergone a macroscopically complete resection with curative intent -Radical surgical approach must have been employed (including liver resection) -ECOG performance status less than/equal to 2 - Adequate renal, haematological and liver function (details specified in protocol) - Age 18 years or over -No history of other malignant diseases (except non-melantotic skin cancer or in-situ carcimoma of cervix) -Women of childbearing potential must not be pregnant and must use adequate contraception during study and for 3 months after the study treatment -Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Pancreatic or Ampullary cancer -Mucosal gallbladder cancer -Incomplete recovery from previous surgery or unresolved biliary tree obstruction -Use of other investigational agents during the study or within 4 weeks of planned entry into the study. -History of second malignancy within 5 years of trial entry, except cervical carcinoma in-situ or non-melanotic skin cancer. -Any previous chemotherapy, radiotherapy, biological or hormone therapy given for biliary tract cancer. -A serious co-exisiting medical condition inlcuding a potential serious infection. -Evidence of significant clinical disorder or laboratory finding which makes it undesirable for the patient to participate in the trial. -Any other serious uncontrolled medical conditions -Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the survival at 2-years of patients treated with capecitabine, compared to those undergoing observation alone, following complete macroscopic surgical resection of biliary tract cancer. ;Secondary Objective: To compare capecitabine versus observation in terms of: 5-year survival Relapse free survival Toxicity Quality of Life Health Economics;Primary end point(s): Primary endpoint: 2-year survival Secondary endpoints: 5-year survival Relapse free survival Toxicity Quality of Life Health Economics | — |
Countries
United Kingdom
Outcome results
None listed