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

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
capecitabine
clinical observation
adjuvant therapy
Sponsored by
University Hospital Southampton NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Basildon University Hospital
  • Basingstoke and North Hampshire NHS Foundation Trust
  • Cancer Research UK Clinical Trials Unit - Birmingham
  • Royal Bournemouth Hospital
  • Bristol Haematology and Oncology Centre
  • Addenbrooke's Hospital
  • Walsgrave Hospital
  • Princess Alexandra Hospital
  • St. Luke's Cancer Centre at Royal Surrey County Hospital
  • Calderdale Royal Hospital
  • Huddersfield Royal Infirmary
  • Cancer Research UK Clinical Centre at St. James's University Hospital
  • Leicester Royal Infirmary
  • Leicester General Hospital
  • Royal Liverpool University Hospital
  • Aintree University Hospital
  • Saint Bartholomew's Hospital
  • Helen Rollason Cancer Care Centre at North Middlesex Hospital
  • UCL Cancer Institute
  • St. Thomas' Hospital
  • King's College Hospital
  • Royal Marsden - London
  • Hammersmith Hospital
  • University College of London Hospitals
  • Maidstone Hospital
  • Christie Hospital
  • North Manchester General Hospital - Penine Actute Hospitals Trust
  • Clatterbridge Centre for Oncology
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • Freeman Hospital
  • St. Mary's Hospital
  • Nottingham City Hospital
  • Derriford Hospital
  • Portsmouth Oncology Centre at Saint Mary's Hospital
  • Alexandra Healthcare NHS
  • Salisbury District Hospital
  • Cancer Research Centre at Weston Park Hospital
  • Southampton General Hospital
  • Royal Marsden - Surrey
  • Southend University Hospital NHS Foundation Trust
  • Yeovil District Hospital
  • Ninewells Hospital
  • Edinburgh Cancer Centre at Western General Hospital
  • Beatson West of Scotland Cancer Centre
  • Perth Royal Infirmary
  • Velindre Cancer Center at Velindre Hospital

Outcomes

Primary Outcome Measures

Survival at 2 years

Secondary Outcome Measures

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

Full Information

First Posted
August 10, 2006
Last Updated
August 23, 2013
Sponsor
University Hospital Southampton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00363584
Brief Title
Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer
Official Title
A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Southampton NHS Foundation Trust

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Other
Intervention Name(s)
clinical observation
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Survival at 2 years
Secondary Outcome Measure Information:
Title
Survival at 5 years
Title
Relapse-free survival
Title
Toxicity
Title
Quality of life
Title
Health economics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clive Stubbs
Organizational Affiliation
Cancer Research Campaign Clinical Trials Centre
Facility Information:
Facility Name
Basildon University Hospital
City
Basildon
State/Province
England
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Basingstoke and North Hampshire NHS Foundation Trust
City
Basingstoke
State/Province
England
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Cancer Research UK Clinical Trials Unit - Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
England
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Princess Alexandra Hospital
City
Essex
State/Province
England
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Calderdale Royal Hospital
City
Halifax
State/Province
England
ZIP/Postal Code
HX3 0PW
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Cancer Research UK Clinical Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
State/Province
England
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Helen Rollason Cancer Care Centre at North Middlesex Hospital
City
London
State/Province
England
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
UCL Cancer Institute
City
London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Royal Marsden - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
State/Province
England
ZIP/Postal Code
W12 OHS
Country
United Kingdom
Facility Name
University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
North Manchester General Hospital - Penine Actute Hospitals Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M8 6RB
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
Newport
State/Province
England
ZIP/Postal Code
PO30 5TG
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Portsmouth Oncology Centre at Saint Mary's Hospital
City
Portsmouth Hants
State/Province
England
ZIP/Postal Code
PO3 6AD
Country
United Kingdom
Facility Name
Alexandra Healthcare NHS
City
Redditch, Worcestershire
State/Province
England
ZIP/Postal Code
B98 7UB
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
State/Province
England
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
State/Province
England
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Perth Royal Infirmary
City
Perth
State/Province
Scotland
ZIP/Postal Code
PH1 1NX
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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