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Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer

NCT01096745 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2011-06-23

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.

Conditions

  • Metastatic Biliary Tract Cancer
  • Locally Advanced Biliary Tract Cancer

Interventions

DRUG

Gemcitabine, Cisplatin

D1,D8 Gemcitabine 1000mg/m2 + N/S 150cc miv over 30mins D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins repeated every 3weeks

DRUG

S-1, Cisplatin

D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks

Sponsors & Collaborators

  • Samsung Medical Center

    collaborator OTHER

  • Dong-A University

    collaborator OTHER

  • Chung-Ang University

    collaborator OTHER

  • Gyeongsang National University Hospital

    lead OTHER

Principal Investigators

  • Hyuk-Chan Kwon, M.D. · Dong-A University Hospital

  • Jung Hun Kang, M.D. · Gyeongsang University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-03-31
Completion
2013-09-30

Countries

  • South Korea

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 NCT01096745 on ClinicalTrials.gov