Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer
- Conditions
- Extrahepatic Bile Duct CancerGallbladder CancerLiver Cancer
- Registration Number
- NCT00363584
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether capecitabine is more effective than observation in treating biliary tract cancer.
PURPOSE: This randomized phase III trial is studying capecitabine to see how well it works compared with observation in treating patients with biliary tract cancer.
- Detailed Description
OBJECTIVES:
Primary
* To determine whether adjuvant chemotherapy with capecitabine has any effect on 2-year survival compared to expectant treatment alone (observation) in patients who have undergone a macroscopically complete surgical resection of a biliary tract cancer.
Secondary
* To compare capecitabine versus observation in terms of 5-year survival, relapse-free survival, toxicity, quality of life, and health economics.
OUTLINE: This is a multicenter, prospective, randomized study. Patients are stratified according to surgical center, disease site (hilar/extrahepatic cholangiocarcinoma vs intrahepatic cholangiocarcinoma vs gallbladder vs intrapancreatic/common bile duct), type of resection (R0 vs R1), and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral capecitabine twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients undergo expectant treatment (observation). Quality of life is assessed at baseline, every 3 months for 1 year, and then every 6 months for 1 year.
All patients are followed for up to 5 years post-randomization.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival at 2 years
- Secondary Outcome Measures
Name Time Method Toxicity Quality of life Health economics Survival at 5 years Relapse-free survival
Trial Locations
- Locations (46)
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorks, England, United Kingdom
St. Thomas' Hospital
🇬🇧London, England, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Basildon University Hospital
🇬🇧Basildon, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, England, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
🇬🇧London, England, United Kingdom
Cancer Research UK Clinical Trials Unit - Birmingham
🇬🇧Birmingham, England, United Kingdom
Princess Alexandra Hospital
🇬🇧Essex, England, United Kingdom
Hammersmith Hospital
🇬🇧London, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
North Manchester General Hospital - Penine Actute Hospitals Trust
🇬🇧Manchester, England, United Kingdom
King's College Hospital
🇬🇧London, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Freeman Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
University College of London Hospitals
🇬🇧London, England, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Royal Marsden - London
🇬🇧London, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
UCL Cancer Institute
🇬🇧London, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Calderdale Royal Hospital
🇬🇧Halifax, England, United Kingdom
Cancer Research UK Clinical Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Leicester General Hospital
🇬🇧Leicester, England, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
St. Mary's Hospital
🇬🇧Newport, England, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
🇬🇧Portsmouth Hants, England, United Kingdom
Alexandra Healthcare NHS
🇬🇧Redditch, Worcestershire, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Perth Royal Infirmary
🇬🇧Perth, Scotland, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, England, United Kingdom