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Extrahepatic Bile Duct CancerPhase 3NCT00363584

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

A Phase 3 study testing capecitabine, clinical observation and adjuvant therapy in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by University Hospital Southampton NHS Foundation Trust at 46 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
capecitabine, clinical observation and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
360 participants
Where
46 sitesUnited Kingdom
Study dates
Mar 2006to Aug 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

United Kingdom46 sites

  • Basildon University Hospital

    Basildon, England, SS16 5NL

  • Basingstoke and North Hampshire NHS Foundation Trust

    Basingstoke, England, RG24 9NA

  • Cancer Research UK Clinical Trials Unit - Birmingham

    Birmingham, England, B15 2TT

  • Royal Bournemouth Hospital

    Bournemouth, England, BH7 7DW

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Princess Alexandra Hospital

    Essex, England, CM20 1QX

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN

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

    Guildford, England, GU2 7XX

  • Calderdale Royal Hospital

    Halifax, England, HX3 0PW

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorks, England, HD3 3EA

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

    Leeds, England, LS16 6QB

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Leicester General Hospital

    Leicester, England, LE5 4PW

  • Royal Liverpool University Hospital

    Liverpool, England, L7 8XP

  • Aintree University Hospital

    Liverpool, England, L9 7AL

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Helen Rollason Cancer Care Centre at North Middlesex Hospital

    London, England, N18 1QX

  • UCL Cancer Institute

    London, England, NW3 2QG

  • St. Thomas' Hospital

    London, England, SE1 7EH

  • King's College Hospital

    London, England, SE5 9RS

  • Royal Marsden - London

    London, England, SW3 6JJ

  • Hammersmith Hospital

    London, England, W12 OHS

  • University College of London Hospitals

    London, England, WIT 3AA

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital

    Manchester, England, M20 4BX

  • North Manchester General Hospital - Penine Actute Hospitals Trust

    Manchester, England, M8 6RB

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Freeman Hospital

    Newcastle upon Tyne, England, NE7 7DN

  • St. Mary's Hospital

    Newport, England, PO30 5TG

  • Nottingham City Hospital

    Nottingham, England, NG5 1PB

  • Perth Royal Infirmary

    Perth, Scotland, PH1 1NX

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Portsmouth Oncology Centre at Saint Mary's Hospital

    Portsmouth Hants, England, PO3 6AD

  • Alexandra Healthcare NHS

    Redditch, Worcestershire, England, B98 7UB

  • Salisbury District Hospital

    Salisbury, England, SP2 8BJ

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, England, SS0 0RY

  • Yeovil District Hospital

    Yeovil, England, BA21 4AT

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
capecitabine, clinical observation, adjuvant therapy
Keywords
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
Medical subject headings
Bile Duct Neoplasms, Gallbladder Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival at 2 years

Secondary outcomes (5)

  1. Survival at 5 years

  2. Relapse-free survival

  3. Toxicity

  4. Quality of life

  5. Health economics

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00363584
Sponsor's protocol ID
CDR0000492266
Other IDs
CRUK-HE3002, EU-20629, EUDRACT-2005-003318-13, ISRCTN72785446, CRUK-BILCAP, CRUK-BIBF1120
Status last verified
Oct 2011
First submitted
10 Aug 2006
Last updated
26 Aug 2013
Results posted
No

Publications

  • Keller HR, Fluke L, Forrester JA, Wolf RF. Identifying Indications for Neoadjuvant Therapy in Cholangiocarcinoma. Oncology (Williston Park). 2024 Apr 11;38(4):160-162. doi: 10.46883/2024.25921017.

    PubMed 38661512

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capecitabine, clinical observation and adjuvant therapy in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by University Hospital Southampton NHS Foundation Trust at 46 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival at 2 years. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00363584, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.

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