Status:
COMPLETED
Capecitabine or Observation After Surgery in Treating Patients With Biliary Tract Cancer
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Conditions:
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 capecitabin...
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 undergon...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00363584
Start Date
March 1 2006
Last Update
August 26 2013
Active Locations (46)
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1
Basildon University Hospital
Basildon, England, United Kingdom, SS16 5NL
2
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
3
Cancer Research UK Clinical Trials Unit - Birmingham
Birmingham, England, United Kingdom, B15 2TT
4
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom, BH7 7DW