BILCAP: A research trial evaluating chemotherapy in patients following surgery for biliary tract cancer
- Conditions
- Biliary tract cancerCancerMalignant neoplasm of other and unspecified parts of biliary tract
- Registration Number
- ISRCTN72785446
- Lead Sponsor
- The University of Southampton
- Brief Summary
2019 Results article in https://doi.org/10.1016/S1470-2045(18)30915-X (added 13/04/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 447
Current information as of 09/02/2010 (update to trial made in December 2008)
1. Patients with histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic/hilar cholangiocarcinoma, muscle invasive gallbladder cancer or cancer of the distal bile duct) who have undergone a macroscopically complete resection with curative intent.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
3. Age > 18
4. Adequate renal function:
4.1. Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN)
4.2. Calculated glomerular filtration rate (GFR) using Cockcroft-Gault = 60 ml/min. If the calculated GFR is below 60 ml/min, isotope EDTA confirmation of adequate renal function (as detailed in the Summary of Product Characteristics [SPC] for capecitabine) is required
5. Adequate haematological function:
5.1. Haemoglobin = 10g/dl
5.2. WBC = 3.0 x 109/L
5.3. Absolute neutrophil count (ANC) = 1.5 x 109/L
5.4. Platelet count = 100,000/mm3
6. Adequate liver function:
6.1. Total bilirubin = 3 x ULN
6.2. Alanine transaminase (ALT) or aspartate transaminase (AST) = 5 x ULN
6.3. Adequate surgical biliary drainage with no evidence of infection
7. Not of childbearing potential OR must be using an approved method of contraception
8. Written informed consent
9. Able to start treatment within 12 weeks of surgery. If the treatment start date is >12 weeks, it will be necessary to contact the BILCAP Trial Office.
Current information as of 28/02/2008:
1. Age 18 or over
2. Histologically confirmed biliary tract cancer (including intrahepatic or extrahepatic cholagiocarcinoma or muscle-invasive gallbladder cancer) and undergone macroscopically complete resection with curative intent
3. No history of other malignant diseases (other than adequately treated non-melanotic skin cancer or in situ carcinoma of the uterine cervix)
4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
5. Adequate renal function (serum urea and serum creatinine less than 1.5 times upper limit of normal [ULN], glomerular filtration rate greater than/equal to 60 ml/min). If the calculated GFR is below 60 ml/min, isotope EDTA confirmation of adequate renal function (as detailed in the Summary of Product Characteristics [SPC] for capecitabine)
6. Adequate haematological function (haemoglobin =10 g/dl, white blood cells [WBC] =3.0 x 10^9/l, absolute neutrophil count [ANC] =1.5 x 10^9/l, platelet count =100,000/mm^3)
7. Adequate liver function (total bilirubin =3 x ULN, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] =5 times ULN, adequate surgical biliary drainage with no evidence of infection)
8. Not of childbearing potential OR must be using an approved method of contraception
9. Written informed consent
Information at time of registration:
1. Age 18 or over
2. Histologically confirmed biliary tract cancer (including intrahepatic or extrahepatic cholagiocarcinoma or muscle-invasive gallbladder cancer)
Current information as of 09/02/2010 (update to trial made in December 2008):
1. Pancreatic or ampullary cancer or mucosal gallbladder cancer
2. Incomplete recovery from previous surgery or unresolved biliary tree obstruction
3. Use of other investigational agents during the study treatment period, or within 4 weeks of planned entry to the study
4. History of other malignancy within 5 years of trial entry, except adequately treated cervical carcinoma-in-situ or non-melanotic skin cancer.
5. Any previous chemotherapy or radiotherapy, given for biliary tract cancer.
6. A serious co-existing medical condition likely to interfere with protocol treatment including a potential serious infection.
7. Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
Information at time of registration:
1. Pancreatic or periampullary cancer or mucosal gallbladder cancer
2. Resection of tumour that involved the pancreas
3. Incomplete recovery from previous surgery or unresolved biliary tree obstruction
4. Use of other investigational agents during the study or within 4 weeks of planned entry to the study
5. Previous chemotherapy, radiotherapy, biological or hormone therapy given for biliary tract cancer
6. History of second malignancy within 5 years of trial entry, except non-melanotic skin cancer or in situ cervical carcinoma
7. A serious co-existing medical condition including a potential serious infection
8. Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
9. Psychological, familial, sociological or geographical factors considered likely to prevent compliance with the protocol
10. Any other serious uncontrolled medical conditions
11. Pregnant or breastfeeding women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method