Condition category
Cancer
Date applied
13/09/2005
Date assigned
17/11/2005
Last edited
10/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof John Primrose

ORCID ID

Contact details

University Surgical Unit
F Level
Centre Block
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

2005-003318-13

ClinicalTrials.gov number

NCT00363584

Protocol/serial number

HE3002

Study information

Scientific title

Acronym

BILCAP

Study hypothesis

To evaluate adjuvant chemotherapy with capecitabine in patients who have undergone complete macroscopic resection of a biliary tract cancer. The primary objective is to determine 2-year survival in patients treated with capecitabine compared to those undergoing observation. The secondary objectives are to compare 5-year survival, relapse-free interval, toxicity, quality of life and healthcare economics.

On 09/02/10 the inclusion and exclusion criteria for this trial were updated. Please see the relevant field for more details. Please also note that the anticipated end date of this trial was extended from 01/10/2008 to 01/03/2011.

Ethics approval

West Midlands Ethics Committee, 04/10/2005. All subsequent amendments have also been approved.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Biliary tract cancer

Intervention

A randomised phase III study of adjuvant chemotherapy with capecitabine compared to expectant treatment alone (observation) in patients following surgical resection of a biliary tract tumour.

Intervention type

Drug

Phase

Phase III

Drug names

Capecitabine

Primary outcome measures

2-year survival

Secondary outcome measures

1. 5-year survival
2. Relapse-free interval
3. Toxicity
4. Quality of life
5. Healthcare economics

Overall trial start date

01/03/2006

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

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) 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)
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 less than 50 µmol/l, 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

360

Participant exclusion criteria

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

Recruitment start date

01/03/2006

Recruitment end date

01/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Surgical Unit
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

The University of Southampton (UK)

Sponsor details

Legal Services
Building 37
Room 4033
The University of Southampton
Southampton
SO17 1BJ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (Ref: C317/A4273)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes