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NCT00363584

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

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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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

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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.

Conditions

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Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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capecitabine

Intervention Type DRUG

clinical observation

Intervention Type OTHER

adjuvant therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Clive Stubbs

Role:

Cancer Research Campaign Clinical Trials Centre

Locations

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Basildon University Hospital

Basildon, England, United Kingdom

Site Status

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, United Kingdom

Site Status

Cancer Research UK Clinical Trials Unit - Birmingham

Birmingham, England, United Kingdom

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Royal Bournemouth Hospital

Bournemouth, England, United Kingdom

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Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

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Addenbrooke's Hospital

Cambridge, England, United Kingdom

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Walsgrave Hospital

Coventry, England, United Kingdom

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Princess Alexandra Hospital

Essex, England, United Kingdom

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St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, United Kingdom

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Calderdale Royal Hospital

Halifax, England, United Kingdom

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Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

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Cancer Research UK Clinical Centre at St. James's University Hospital

Leeds, England, United Kingdom

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Leicester Royal Infirmary

Leicester, England, United Kingdom

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Leicester General Hospital

Leicester, England, United Kingdom

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Royal Liverpool University Hospital

Liverpool, England, United Kingdom

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