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Gemcitabine Plus High-Dose 5-Fu/Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract

NCT00201305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-04-01

No results posted yet for this study

Summary

This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FU/leucovorin infusion (HDFL) for patients with advanced or metastatic carcinoma of the biliary tract. The primary endpoint is patients' response and the secondary endpoints are chemotherapy-related toxicity, time to disease progression and overall survival. .

Conditions

  • Biliary Tract Disease

Interventions

DRUG

Gemcitabine+5FU+Leucovorin

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Changhua Christian Hospital

    collaborator OTHER

  • China Medical University Hospital

    collaborator OTHER

  • Mackay Memorial Hospital

    collaborator OTHER

  • Chi Mei Medical Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • National Taiwan University Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Ann-Li Cheng, PHD · National Taiwan University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Completion
2012-08-31

Countries

  • Taiwan

Study Locations

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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 NCT00201305 on ClinicalTrials.gov