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Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma

NCT01375972 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2011-12-06

No results posted yet for this study

Summary

To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.

Conditions

  • Metastatic Biliary Cancer

Interventions

DRUG

S-1 plus cisplatin

S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks

DRUG

Gemcitabine plus Cisplatin

Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • MJ Kang, MD, MSc · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-07-31
Completion
2011-08-31

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 NCT01375972 on ClinicalTrials.gov