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

NCT00363584 | Completed Phase 3

• 7 other identifiers: CDR0000492266CRUK-HE3002EU-20629EUDRACT-2005-003318-13ISRCTN72785446CRUK-BILCAPCRUK-BIBF1120
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 46

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Survival at 2 years

Secondary Outcomes (5)

• Survival at 5 years

• Relapse-free survival

• Toxicity

• Quality of life

• Health economics

Interventions

capecitabine DRUG

clinical observation OTHER

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (46)

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Cancer Research UK Clinical Trials Unit - Birmingham

Birmingham, England, B15 2TT, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Princess Alexandra Hospital

Essex, England, CM20 1QX, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Calderdale Royal Hospital

Halifax, England, HX3 0PW, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Cancer Research UK Clinical Centre at St. James's University Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Leicester General Hospital

Leicester, England, LE5 4PW, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Helen Rollason Cancer Care Centre at North Middlesex Hospital

London, England, N18 1QX, United Kingdom

Location

UCL Cancer Institute

London, England, NW3 2QG, United Kingdom

Location

St. Thomas' Hospital

London, England, SE1 7EH, United Kingdom

Location

King's College Hospital

London, England, SE5 9RS, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Hammersmith Hospital

London, England, W12 OHS, United Kingdom

Location

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

North Manchester General Hospital - Penine Actute Hospitals Trust

Manchester, England, M8 6RB, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

St. Mary's Hospital

Newport, England, PO30 5TG, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, PO3 6AD, United Kingdom

Location

Alexandra Healthcare NHS

Redditch, Worcestershire, England, B98 7UB, United Kingdom

Location

Salisbury District Hospital

Salisbury, England, SP2 8BJ, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Yeovil District Hospital

Yeovil, England, BA21 4AT, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Perth Royal Infirmary

Perth, Scotland, PH1 1NX, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Related Publications (1)

• Keller HR, Fluke L, Forrester JA, Wolf RF. Identifying Indications for Neoadjuvant Therapy in Cholangiocarcinoma. Oncology (Williston Park). 2024 Apr 11;38(4):160-162. doi: 10.46883/2024.25921017.

  PMID: 38661512 DERIVED

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms; Liver Neoplasms

Interventions

Capecitabine; Watchful Waiting; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Clive Stubbs

  Cancer Research Campaign Clinical Trials Centre

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: March 1, 2006
• Primary Completion: August 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2011-10

Locations

GB (46)