A randomised clinical trial evaluating adjuvant chemotherapy with capecitabine compared to expectant treatment alone following surgery for biliary tract cancer. - BILCAP
- Conditions
- 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).
- Registration Number
- EUCTR2005-003318-13-GB
- Lead Sponsor
- The University of Southampton
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 360
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>5-year survival<br>Relapse free survival<br>Toxicity<br>Quality of Life<br>Health Economics;Primary end point(s): Primary endpoint: 2-year survival<br><br>Secondary endpoints:<br>5-year survival<br>Relapse free survival<br>Toxicity<br>Quality of Life<br>Health Economics
- Secondary Outcome Measures
Name Time Method