BILCAP: A research trial evaluating chemotherapy in patients following surgery for biliary tract cancer
| ISRCTN | ISRCTN72785446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72785446 |
| EudraCT/CTIS number | 2005-003318-13 |
| ClinicalTrials.gov number | NCT00363584 |
| Secondary identifying numbers | HE3002 |
- Submission date
- 13/09/2005
- Registration date
- 17/11/2005
- Last edited
- 13/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Prof John Primrose
Scientific
Scientific
University Surgical Unit
F Level, Centre Block
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised clinical trial evaluating adjuvant chemotherapy with capecitabine compared to expectant treatment alone (observation), following surgical resection of a biliary tract tumour |
| Study 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(s) | West Midlands Ethics Committee, 04/10/2005, ref: 05/MRE07/62 |
| Condition | Biliary tract cancer |
| Intervention | Current interventions as of 24/03/2017: This is a multicentre, prospective, randomised phase III trial of patients who have undergone a macroscopically complete surgical resection of a biliary tract cancer. Those patients who fulfil the inclusion criteria are stratified by surgical centre, tumour site (hilar/extrahepatic cholangiocarcinoma, intrahepatic cholangiocarcinoma, lower common bile duct cholangiocarcinoma and gall bladder carcinoma), and by the type of resection (RO/R1) and performance status (ECOG PS 0,1,2), and randomised to either: Treatment arm: Capecitabine 1250 mg/m2 given post-operatively twice a day on day 1 to 14 of a 3 weekly cycle for 24 weeks (8 cycles). Control arm: No scheduled post-operative chemotherapy. A total of 447 patients who have undergone a macroscopically complete surgical resection of a biliary tract cancer will be randomised equally into each arm of the study, and will be followed-up for 5 years. Previous interventions: 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Capecitabine |
| Primary outcome measure | 2-year survival |
| Secondary outcome measures | Current secondary outcome measures as of 24/03/2017: 1. 5-year survival 2. Relapse is measured by 3 monthly follow up visits for 1st year, 6 monthly follow up visits for 2nd year and annual visits for up to 5 years from randomisation. 6 monthly CT scans (chest/abdo/pelvis) for first two years and then annually for up to 5 years from randomisation 3. Toxicity is measured on Day 1 of every treatment cycle and at the end of treatment (within 4 weeks of last treatment administered). Long-term toxicities are measured during follow up visits 3 monthly follow up visits for 1st year, 6 monthly follow up visits for 2nd year and annual visits for up to 5 years from randomisation 4. Quality of life is assessed using EORTC QoL questionnaire (QLQ-C30 ) version 3 with the EORTC QLQ-LMC21 site-specific add-on and EuroQoL (5 questions). QOL is measured at baseline, 3 monthly for the 1st year and 6 monthly for the 2nd year 5. Healthcare economics to assess the relative cost effectiveness of the treatment regimes (chemotherapy or observation) for the duration of treatment and for the first two years of follow-up, using the same sub-set of QoL patients. The collection of the data for the economic evaluation is collected by adding the health problems questionnaire (5 questions) -to the QOL booklet to ascertain the resource use. Previous secondary outcome measures: 1. 5-year survival 2. Relapse 3. Toxicity 4. Quality of life 5. Healthcare economics |
| Overall study start date | 01/01/2005 |
| Overall study end date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 360 |
| Total final enrolment | 447 |
| 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 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 | 10/07/2006 |
| Recruitment end date | 04/12/2014 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Southampton General Hospital (Lead Centre)
University Surgical Unit
Tremona Road
Southampton
SO16 6YD
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Basildon & Thurrock University Hospital
Nethermayne
Essex
Basildon
SS16 5NL
United Kingdom
Essex
Basildon
SS16 5NL
United Kingdom
Basingstoke and North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Beatson West of Scotland Cancer Centre
1053 Gt. Western Road
Glasgow
G12 0YN
United Kingdom
Glasgow
G12 0YN
United Kingdom
Bristol Haematology And Oncology Centre
Horfield Road
Bristol
BS2 8ED
United Kingdom
Bristol
BS2 8ED
United Kingdom
Christie Hospital
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
Withington
Manchester
M20 4BX
United Kingdom
Clatterbridge Cancer Centre
Clatterbridge Road
Wirral
Bebington
CH63 4JY
United Kingdom
Wirral
Bebington
CH63 4JY
United Kingdom
Derriford Hospital
Derriford Road
Crownhill
Plymouth
PL6 8DH
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
London
W12 0HS
United Kingdom
Huddersfield Royal Infirmary
Lindley
Huddersfield
HD3 3EA
United Kingdom
Huddersfield
HD3 3EA
United Kingdom
James Paget Hospital
Lowestoft Road
Gorleston
Great Yarmouth
Norfolk
NR31 6LA
United Kingdom
Gorleston
Great Yarmouth
Norfolk
NR31 6LA
United Kingdom
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Leicester
LE5 4PW
United Kingdom
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
LE1 5WW
United Kingdom
Maidstone Hospital
Hermitage Lane
Kent
Maidstone
ME16 9QQ
United Kingdom
Kent
Maidstone
ME16 9QQ
United Kingdom
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
North Manchester General Hospital
Delaunays Road
Manchester
M8 5RB
United Kingdom
Manchester
M8 5RB
United Kingdom
North Middlesex Hospital
Sterling Way
London
N18 1QX
United Kingdom
London
N18 1QX
United Kingdom
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Nottingham
NG5 1PB
United Kingdom
Poole Hospital
Longfleet Road
Dorset
Poole
BH15 2JB
United Kingdom
Dorset
Poole
BH15 2JB
United Kingdom
Princess Alexandra Hospital
Hamstel Road
Harlow
CM20 1QX
United Kingdom
Harlow
CM20 1QX
United Kingdom
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Derby
DE22 3NE
United Kingdom
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
London
NW3 2QG
United Kingdom
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
Liverpool
L7 8XP
United Kingdom
Royal Marsden Hospital London
Fulham Road
London
SW3 6JJ
United Kingdom
London
SW3 6JJ
United Kingdom
Royal Marsden Hospital Sutton
Downs Road
Sutton
SM2 5PT
United Kingdom
Sutton
SM2 5PT
United Kingdom
Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom
Guildford
GU2 7XX
United Kingdom
Salisbury District Hospital
Salisbury
SP2 8BJ
United Kingdom
SP2 8BJ
United Kingdom
Southend University Hospital
Pritilewell Chase
Westcliff on Sea
SS0 0RY
United Kingdom
Westcliff on Sea
SS0 0RY
United Kingdom
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
London
EC1A 7BE
United Kingdom
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Leeds
LS9 7TF
United Kingdom
St Mary's Hospital
Parkhurst Road
Newport
PO30 5TG
United Kingdom
Newport
PO30 5TG
United Kingdom
St Thomas's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
London
SE1 9RT
United Kingdom
University College London Hospital
250 Euston Road
London
NW1 2PQ
United Kingdom
London
NW1 2PQ
United Kingdom
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom
Liverpool
L9 7AL
United Kingdom
University Hospital Coventry & Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DZ
United Kingdom
Coventry
CV2 2DZ
United Kingdom
Velindre Hospital
Velindre Road
Whitchurch
Cardiff
CF14 2TL
United Kingdom
Whitchurch
Cardiff
CF14 2TL
United Kingdom
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
EH4 2XU
United Kingdom
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
Sheffield
S10 2SJ
United Kingdom
Yeovil District Hospital
Somerset
BA21 4A
United Kingdom
BA21 4A
United Kingdom
Sponsor information
The University of Southampton
University/education
University/education
Legal Services
Building 37, Room 4033
The University of Southampton
Southampton
SO17 1BJ
England
United Kingdom
"ROR" |
https://ror.org/01ryk1543 |
|---|
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (Ref: C317/A4273)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | An abstract of the trial results has been submitted to ASCO 06/02/2017. A publication in a high-impact peer reviewed journal is planned for 2017. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from BILCAP@trials.bham.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | 08/08/2019 | No | Yes | ||
| Results article | 25/03/2019 | 13/04/2022 | Yes | No |
Editorial Notes
13/04/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
08/08/2019: A link to results was added to Results (plain English).
24/03/2017: Updated public title, ethics and outcome measures. Overall trial dates changed from 01/03/2006 - 01/03/2011 to 01/01/2005 - 31/12/2020. Recruitment dates changed from 01/03/2006 - 01/03/2011 to 10/07/2006 - 04/12/2014. Added trial participating sites.
20/03/2017: No publications found in PubMed, verifying study status with principal investigator.
