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

Phase 3

Completed

• Conditions: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer

• Registration Number: NCT00363584
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Status Verified: 2011-10
• Primary Completion: 2013-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival at 2 years

Secondary Outcome Measures

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

Trial Locations

Locations (46)

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

Walsgrave Hospital; 🇬🇧 Coventry, England, United Kingdom

Princess Alexandra Hospital; 🇬🇧 Essex, England, United Kingdom

St. Luke's Cancer Centre at Royal Surrey County Hospital; 🇬🇧 Guildford, England, United Kingdom

Calderdale Royal Hospital; 🇬🇧 Halifax, England, United Kingdom

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