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| Sponsor: | Southampton General Hospital |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00363584 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer |
Drug: capecitabine Procedure: adjuvant therapy Procedure: observation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer |
| Estimated Enrollment: | 360 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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), type of resection (R0 vs R1), and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed biliary tract cancer (including intrahepatic or extrahepatic/hilar cholangiocarcinoma or muscle invasive gallbladder cancer)
Must have undergone a macroscopically complete resection with curative intent that included liver resection
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United Kingdom, England | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Contact Person 44-1223-245-151 | |
| Aintree University Hospital | Recruiting |
| Liverpool, England, United Kingdom, L9 7AL | |
| Contact: Contact Person 44-151-525-5980 | |
| Bristol Haematology and Oncology Centre | Recruiting |
| Bristol, England, United Kingdom, BS2 8ED | |
| Contact: Contact Person 44-117-928-3074 | |
| Calderdale Royal Hospital | Recruiting |
| Halifax, England, United Kingdom, HX3 0PW | |
| Contact: Contact Person 44-1422-357-171 | |
| Cancer Research Centre at Weston Park Hospital | Recruiting |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Contact: Contact Person 44-114-226-5000 | |
| Cancer Research UK Clinical Trials Unit - Birmingham | Recruiting |
| Birmingham, England, United Kingdom, B15 2TT | |
| Contact: Alice Miles 44-121-414-7671 | |
| Christie Hospital | Recruiting |
| Manchester, England, United Kingdom, M20 4BX | |
| Contact: Contact Person 44-845-226-3000 | |
| Clatterbridge Centre for Oncology | Recruiting |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Contact: Contact Person 44-151-334-1155 | |
| North Manchester General Hospital - Penine Actute Hospitals Trust | Recruiting |
| Manchester, England, United Kingdom, M8 6RB | |
| Contact: Contact Person 44-161-795-4567 | |
| Derriford Hospital | Recruiting |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Contact: Contact Person 44-175-277-7111 | |
| Hammersmith Hospital | Recruiting |
| London, England, United Kingdom, W12 OHS | |
| Contact: Contact Person 44-20-8383-1000 | |
| Helen Rollason Cancer Care Centre at North Middlesex Hospital | Recruiting |
| London, England, United Kingdom, N18 1QX | |
| Contact: Contact Person 44-20-8887-2000 | |
| Huddersfield Royal Infirmary | Recruiting |
| Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
| Contact: Contact Person 44-1484-342-000 | |
| Leicester General Hospital | Recruiting |
| Leicester, England, United Kingdom, LE5 4PW | |
| Contact: Contact Person 44-116-249-0490 | |
| Leicester Royal Infirmary | Recruiting |
| Leicester, England, United Kingdom, LE1 5WW | |
| Contact: Contact Person 44-116-254-1414 | |
| Maidstone Hospital | Recruiting |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Contact: Contact Person 44-1622-729-000 | |
| Cookridge Hospital | Recruiting |
| Leeds, England, United Kingdom, LS16 6QB | |
| Contact: Contact Person 44-113-267-3411 | |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting |
| Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
| Contact: Contact Person 44-191-219-4200 | |
| Nottingham City Hospital NHS Trust | Recruiting |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Contact: Contact Person 44-115-969-1169 | |
| Princess Alexandra Hospital | Recruiting |
| Essex, England, United Kingdom, CM20 1QX | |
| Contact: Contact Person 44-1279-444-455 | |
| Royal Bournemouth Hospital NHS Trust | Recruiting |
| Bournemouth, England, United Kingdom, BH7 7DW | |
| Contact: Contact Person 44-202-303-626 | |
| Royal Liverpool University Hospital | Recruiting |
| Liverpool, England, United Kingdom, L7 8XP | |
| Contact: Contact Person 44-151-706-2000 | |
| Salisbury District Hospital | Recruiting |
| Salisbury, England, United Kingdom, SP2 8BJ | |
| Contact: Contact Person 44-1722-336-262 | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: Contact Person 44-20-8642-6011 | |
| Saint Bartholomew's Hospital | Recruiting |
| London, England, United Kingdom, EC1A 7BE | |
| Contact: Contact Person 44-20-7601-8391 | |
| Royal Marsden - London | Recruiting |
| London, England, United Kingdom, SW3 6JJ | |
| Contact: Contact Person 44-20-7352-8171 | |
| Southampton General Hospital | Recruiting |
| Southampton, England, United Kingdom, SO16 6YD | |
| Contact: Contact Person 44-23-8079-8751 | |
| St. Luke's Cancer Centre at Royal Surrey County Hospital | Recruiting |
| Guildford, England, United Kingdom, GU2 7XX | |
| Contact: Contact Person 44-1483-571-122 | |
| St. Thomas' Hospital | Recruiting |
| London, England, United Kingdom, SE1 7EH | |
| Contact: Contact Person 44-171-922-8009 | |
| UCL Cancer Institute | Recruiting |
| London, England, United Kingdom, NW3 2QG | |
| Contact: Contact Person 44-207-476-100 | |
| University College of London Hospitals | Recruiting |
| London, England, United Kingdom, WIT 3AA | |
| Contact: Contact Person 44-20-7636-8333 | |
| Yeovil District Hospital | Recruiting |
| Yeovil, England, United Kingdom, BA21 4AT | |
| Contact: Contact Person 44-1935-475-122 | |
| United Kingdom, Scotland | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, Scotland, United Kingdom, G12 0YN | |
| Contact: Contact Person 44-141-211-2123 | |
| Edinburgh Cancer Centre at Western General Hospital | Recruiting |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Contact: Contact Person 44-131-537-1000 | |
| United Kingdom, Wales | |
| Velindre Cancer Center at Velindre Hospital | Recruiting |
| Cardiff, Wales, United Kingdom, CF14 2TL | |
| Contact: Contact Person 44-29-2031-6292 | |
| Investigator: | Clive Stubbs | Cancer Research Campaign Clinical Trials Centre |
More Information
| Study ID Numbers: | CDR0000492266, CRUK-HE3002, EU-20629, EUDRACT-2005-003318-13, ISRCTN72785446, CRUK-BILCAP, CRUK-BIBF1120 |
| Study First Received: | August 10, 2006 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00363584 History of Changes |
| Health Authority: | Unspecified |
|
localized resectable adult primary liver cancer cholangiocarcinoma of the extrahepatic bile duct cholangiocarcinoma of the gallbladder adenocarcinoma of the gallbladder adenocarcinoma with squamous metaplasia of the gallbladder |
anaplastic carcinoma of the gallbladder localized gallbladder cancer localized extrahepatic bile duct cancer squamous cell carcinoma of the gallbladder adult primary cholangiocellular carcinoma |
|
Antimetabolites Gallbladder Diseases Capecitabine Liver Diseases Antimetabolites, Antineoplastic Biliary Tract Neoplasms Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Adjuvants, Immunologic Pharmacologic Actions Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Bile Duct Diseases Therapeutic Uses Biliary Tract Diseases Gallbladder Neoplasms Bile Duct Neoplasms |