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

Liver Cancer Clinical Trial

Official title:

A Randomised Clinical Trial Evaluating Adjuvant Chemotherapy With Capecitabine Compared to Expectant Treatment Alone (Observation) Following Surgery for Biliary Tract Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363584
• Other study ID #: CDR0000492266
• Secondary ID: CRUK-HE3002EU-20
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2006
• Last updated: August 23, 2013
• Start date: March 2006

Study information

• Verified date: October 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• capecitabine

Other:
• clinical observation

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United Kingdom	Basildon University Hospital	Basildon	England
United Kingdom	Basingstoke and North Hampshire NHS Foundation Trust	Basingstoke	England
United Kingdom	Cancer Research UK Clinical Trials Unit - Birmingham	Birmingham	England
United Kingdom	Royal Bournemouth Hospital	Bournemouth	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Princess Alexandra Hospital	Essex	England
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England
United Kingdom	Calderdale Royal Hospital	Halifax	England
United Kingdom	Huddersfield Royal Infirmary	Huddersfield, West Yorks	England
United Kingdom	Cancer Research UK Clinical Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester General Hospital	Leicester	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	Royal Liverpool University Hospital	Liverpool	England
United Kingdom	Hammersmith Hospital	London	England
United Kingdom	Helen Rollason Cancer Care Centre at North Middlesex Hospital	London	England
United Kingdom	King's College Hospital	London	England
United Kingdom	Royal Marsden - London	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. Thomas' Hospital	London	England
United Kingdom	UCL Cancer Institute	London	England
United Kingdom	University College of London Hospitals	London	England
United Kingdom	Maidstone Hospital	Maidstone	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	North Manchester General Hospital - Penine Actute Hospitals Trust	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	Freeman Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	St. Mary's Hospital	Newport	England
United Kingdom	Nottingham City Hospital	Nottingham	England
United Kingdom	Perth Royal Infirmary	Perth	Scotland
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Portsmouth Oncology Centre at Saint Mary's Hospital	Portsmouth Hants	England
United Kingdom	Alexandra Healthcare NHS	Redditch, Worcestershire	England
United Kingdom	Salisbury District Hospital	Salisbury	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden - Surrey	Sutton	England
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England
United Kingdom	Yeovil District Hospital	Yeovil	England

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at 2 years			No
Secondary	Survival at 5 years			No
Secondary	Relapse-free survival			No
Secondary	Toxicity			Yes
Secondary	Quality of life			No
Secondary	Health economics			No