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Trial record 1 of 1 for:    BILCAP
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Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00363584
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE August 10, 2006
First Posted Date  ICMJE August 15, 2006
Last Update Posted Date August 26, 2013
Study Start Date  ICMJE March 2006
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Survival at 2 years
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
  • Survival at 5 years
  • Relapse-free survival
  • Toxicity
  • Quality of life
  • Health economics
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
Intervention  ICMJE
  • Drug: capecitabine
  • Other: clinical observation
  • Procedure: adjuvant therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 13, 2007)
360
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed biliary tract cancer (including intrahepatic or extrahepatic/hilar cholangiocarcinoma or muscle invasive gallbladder cancer or cancer of the distal bile duct)

    • Must have undergone a radical surgical approach which includes liver resection, pancreatic resection, or less commonly both
    • 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 12 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 (if < 60 mL/min, adequate renal function for capecitabine must be confirmed by isotope EDTA)
  • 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 at least 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 likely to interfere with protocol treatment, including a potential serious infection
  • 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 within 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries Australia
 
Administrative Information
NCT Number  ICMJE NCT00363584
Other Study ID Numbers  ICMJE CDR0000492266
CRUK-HE3002
EU-20629
EUDRACT-2005-003318-13
ISRCTN72785446
CRUK-BILCAP
CRUK-BIBF1120
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital Southampton NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Clive Stubbs Cancer Research Campaign Clinical Trials Centre
PRS Account National Cancer Institute (NCI)
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP