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

Phase 3
18 Years
Open (Enrolling)
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

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Trial Information

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



- 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.


- 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

- 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.

Inclusion Criteria


- 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

- Must be able to start treatment within 12 weeks of surgery

- No pancreatic or periampullary cancer

- No mucosal gallbladder cancer


- 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


- See Disease Characteristics

- Completely recovered from prior surgery

- No use of other investigational agents within 28 days prior to and during study

- No prior chemotherapy or radiotherapy for biliary tract cancer

- No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Survival at 2 years

Safety Issue:


Principal Investigator

Clive Stubbs

Investigator Affiliation:

Cancer Research Campaign Clinical Trials Centre



Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • 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
  • Liver Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Biliary Tract Neoplasms