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Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer

This study is currently recruiting participants.
Study NCT00363584.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer
Official Title  A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer
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 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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized
Primary Outcome Measure  Survival at 2 years [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Intervention  Drug: capecitabine
Procedure: adjuvant therapy
Procedure: observation
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  360
Start Date  March 2006
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United Kingdom
Administrative Information Fields
NCT ID  NCT00363584
Organization ID CDR0000492266
Secondary IDs †† CRUK-HE3002, EU-20629, EUDRACT-2005-003318-13, ISRCTN72785446, CRUK-BILCAP, CRUK-BIBF1120
Study Sponsor  Southampton General Hospital
Collaborators ††
Investigators 
Investigator:     Clive Stubbs     Cancer Research Campaign Clinical Trials Centre    
Information Provided By National Cancer Institute (NCI)
Verification Date March 2008
First Received Date  August 10, 2006
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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