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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00363584
First received: August 10, 2006
Last updated: August 23, 2013
Last verified: October 2011

August 10, 2006
August 23, 2013
March 2006
August 2013   (final data collection date for primary outcome measure)
Survival at 2 years [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00363584 on ClinicalTrials.gov Archive Site
  • Survival at 5 years [ Designated as safety issue: No ]
  • Relapse-free survival [ 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 ]
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Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer
A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • Drug: capecitabine
  • Other: clinical observation
  • Procedure: adjuvant therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
Not Provided
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00363584
CDR0000492266, CRUK-HE3002, EU-20629, EUDRACT-2005-003318-13, ISRCTN72785446, CRUK-BILCAP, CRUK-BIBF1120
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University Hospital Southampton NHS Foundation Trust.
Not Provided
Investigator: Clive Stubbs Cancer Research Campaign Clinical Trials Centre
National Cancer Institute (NCI)
October 2011

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