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11 February 2012
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| [ Print-friendly version ] |
| A randomised clinical trial evaluating adjuvant chemotherapy with capecitabine compared to expectant treatment alone (observation), following surgical resection of a biliary tract tumour |
| ISRCTN | ISRCTN72785446 |
| ClinicalTrials.gov identifier | NCT00363584 |
| Public title | A randomised clinical trial evaluating adjuvant chemotherapy with capecitabine compared to expectant treatment alone (observation), following surgical resection of a biliary tract tumour |
| Scientific title | |
| Acronym | BILCAP |
| Serial number at source | HE3002 |
| 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.
Please note that as of 09/02/10 the inclusion and exclusion criteria for this trial have been updated. Please see the relevant field for more details. Please also note that anticipated end date of this trial has been extended from 01/10/08 to 01/03/2011. |
| Lay summary | http://www.cancerhelp.org.uk/trials/a-trial-looking-at-capecitabine-after-surgery-for-cancer-of-the-bile-duct-or-gallbladder |
| Ethics approval | West Midlands Ethics Committee on 04/10/2005. All subsequent ammendments have also been approved. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Biliary tract cancer |
| Participants - inclusion criteria |
Current information as of 09/02/10 (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 years 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 or 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 years 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 or contraception 9. Written informed consent Information at time of registration: 1. Age 18 years 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 or contraception 9. Written informed consent |
| Participants - exclusion criteria |
Current information as of 09/02/10 (update to trialmade 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 |
| Anticipated start date | 01/03/2006 |
| Anticipated end date | 01/03/2011 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 360 |
| 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. |
| Primary outcome measure(s) | 2-year survival |
| Secondary outcome measure(s) |
1. 5-year survival
2. Relapse-free interval 3. Toxicity 4. Quality of life 5. Healthcare economics |
| Sources of funding | Cancer Research UK (CRUK) (UK) (Ref: C317/A4273) |
| Trial website | http://www.bilcap.bham.ac.uk |
| Publications | |
| Contact name | Prof John Primrose |
| Address |
University Surgical Unit
F Level, Centre Block Southampton General Hospital |
| City/town | Southampton |
| Zip/Postcode | SO16 6YD |
| Country | United Kingdom |
| Sponsor | The University of Southampton (UK) |
| Address |
Legal Services
Building 37, Room 4033 The University of Southampton |
| City/town | Southampton |
| Zip/Postcode | SO17 1BJ |
| Country | United Kingdom |
| Date applied | 13/09/2005 |
| Last edited | 02/08/2011 |
| Date ISRCTN assigned | 17/11/2005 |
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