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

August 23, 2013 updated by: University Hospital Southampton NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

360

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- England
  - Basildon, England, United Kingdom, SS16 5NL
    - Basildon University Hospital
  - Basingstoke, England, United Kingdom, RG24 9NA
    - Basingstoke and North Hampshire NHS Foundation Trust
  - Birmingham, England, United Kingdom, B15 2TT
    - Cancer Research UK Clinical Trials Unit - Birmingham
  - Bournemouth, England, United Kingdom, BH7 7DW
    - Royal Bournemouth Hospital
  - Bristol, England, United Kingdom, BS2 8ED
    - Bristol Haematology and Oncology Centre
  - Cambridge, England, United Kingdom, CB2 2QQ
    - Addenbrooke's Hospital
  - Coventry, England, United Kingdom, CV2 2DX
    - Walsgrave Hospital
  - Essex, England, United Kingdom, CM20 1QX
    - Princess Alexandra Hospital
  - Guildford, England, United Kingdom, GU2 7XX
    - St. Luke's Cancer Centre at Royal Surrey County Hospital
  - Halifax, England, United Kingdom, HX3 0PW
    - Calderdale Royal Hospital
  - Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
    - Huddersfield Royal Infirmary
  - Leeds, England, United Kingdom, LS16 6QB
    - Cancer Research UK Clinical Centre at St. James's University Hospital
  - Leicester, England, United Kingdom, LE1 5WW
    - Leicester Royal Infirmary
  - Leicester, England, United Kingdom, LE5 4PW
    - Leicester General Hospital
  - Liverpool, England, United Kingdom, L9 7AL
    - Aintree University Hospital
  - Liverpool, England, United Kingdom, L7 8XP
    - Royal Liverpool University Hospital
  - London, England, United Kingdom, EC1A 7BE
    - Saint Bartholomew's Hospital
  - London, England, United Kingdom, SW3 6JJ
    - Royal Marsden - London
  - London, England, United Kingdom, W12 OHS
    - Hammersmith Hospital
  - London, England, United Kingdom, WIT 3AA
    - University College of London Hospitals
  - London, England, United Kingdom, SE5 9RS
    - King's College Hospital
  - London, England, United Kingdom, NW3 2QG
    - UCL Cancer Institute
  - London, England, United Kingdom, SE1 7EH
    - St. Thomas' Hospital
  - London, England, United Kingdom, N18 1QX
    - Helen Rollason Cancer Care Centre at North Middlesex Hospital
  - Maidstone, England, United Kingdom, ME16 9QQ
    - Maidstone Hospital
  - Manchester, England, United Kingdom, M20 4BX
    - Christie Hospital
  - Manchester, England, United Kingdom, M8 6RB
    - North Manchester General Hospital - Penine Actute Hospitals Trust
  - Merseyside, England, United Kingdom, CH63 4JY
    - Clatterbridge Centre for Oncology
  - Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
    - Freeman Hospital
  - Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
    - Northern Centre for Cancer Treatment at Newcastle General Hospital
  - Newport, England, United Kingdom, PO30 5TG
    - St. Mary's Hospital
  - Nottingham, England, United Kingdom, NG5 1PB
    - Nottingham City Hospital
  - Plymouth, England, United Kingdom, PL6 8DH
    - Derriford Hospital
  - Portsmouth Hants, England, United Kingdom, PO3 6AD
    - Portsmouth Oncology Centre at Saint Mary's Hospital
  - Redditch, Worcestershire, England, United Kingdom, B98 7UB
    - Alexandra Healthcare NHS
  - Salisbury, England, United Kingdom, SP2 8BJ
    - Salisbury District Hospital
  - Sheffield, England, United Kingdom, S1O 2SJ
    - Cancer Research Centre at Weston Park Hospital
  - Southampton, England, United Kingdom, SO16 6YD
    - Southampton General Hospital
  - Sutton, England, United Kingdom, SM2 5PT
    - Royal Marsden - Surrey
  - Westcliff-On-Sea, England, United Kingdom, SS0 0RY
    - Southend University Hospital NHS Foundation Trust
  - Yeovil, England, United Kingdom, BA21 4AT
    - Yeovil District Hospital
- Scotland
  - Dundee, Scotland, United Kingdom, DD1 9SY
    - Ninewells Hospital
  - Edinburgh, Scotland, United Kingdom, EH4 2XU
    - Edinburgh Cancer Centre at Western General Hospital
  - Glasgow, Scotland, United Kingdom, G12 0YN
    - Beatson West of Scotland Cancer Centre
  - Perth, Scotland, United Kingdom, PH1 1NX
    - Perth Royal Infirmary
- Wales
  - Cardiff, Wales, United Kingdom, CF14 2TL
    - Velindre Cancer Center at Velindre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival at 2 years

Secondary Outcome Measures

Outcome Measure
Toxicity
Quality of life
Relapse-free survival
Health economics
Survival at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Investigators

Clive Stubbs, Cancer Research Campaign Clinical Trials Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria

August 10, 2006

First Posted (ESTIMATE)

August 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000492266
CRUK-HE3002
EU-20629
EUDRACT-2005-003318-13
ISRCTN72785446
CRUK-BILCAP
CRUK-BIBF1120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.