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Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008
First Received: August 10, 2006   Last Updated: February 6, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival at 2 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival at 5 years [ Designated as safety issue: No ]
  • Relapse-free interval [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Health economics [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: March 2006
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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 interval, 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), 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.

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
Criteria

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

      • No prior resection that involved the pancreas
    • Patients with pathological evidence of microscopic involvement of the margins of the excised specimen are eligible as long as resection is macroscopically complete
  • Must be able to start treatment within 8 weeks of surgery
  • No pancreatic or periampullary cancer
  • No mucosal gallbladder cancer

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Urea < 1.5 times upper limit of normal (ULN)
  • Creatinine < 1.5 times ULN
  • Glomerular filtration rate ≥ 60 mL/min
  • Hemoglobin ≥ 10 g/dL
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin < 3 times ULN
  • ALT and AST ≤ 5 times ULN
  • Adequate surgical biliary drainage with no evidence of infection
  • Not pregnant or nursing
  • Negative pregnancy test for women of childbearing age and childbearing potential
  • Fertile patients must use effective contraception during study treatment and for 3 months after study treatment has ended
  • Must provide written informed consent
  • No history of other malignant diseases within the past 5 years other than adequately treated nonmelanoma skin cancer or in situ carcinoma of the uterine cervix
  • No serious co-existing medical condition, including a potential serious infection that would interfere with study treatment
  • No evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
  • No psychological, familial, sociological, or geographical factors considered likely to preclude study compliance
  • No other serious uncontrolled medical conditions
  • No unresolved biliary tree obstruction

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Completely recovered from prior surgery
  • No use of other investigational agents for 28 days prior to and during study treatment
  • No prior chemotherapy or radiotherapy for biliary tract cancer
  • No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363584

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        
Sponsors and Collaborators
Southampton General Hospital
Investigators
Investigator: Clive Stubbs Cancer Research Campaign Clinical Trials Centre
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009