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

NCT00363584 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2013-08-26

No results posted yet for this study

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

Interventions

DRUG

capecitabine

OTHER

clinical observation

PROCEDURE

adjuvant therapy

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Clive Stubbs · Cancer Research Campaign Clinical Trials Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2013-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00363584 on ClinicalTrials.gov