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

June 21, 2011 updated by: Gyeongsang National University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Standard chemotherapy regimen for biliary tract cancer(BTC) has not been established due to the difficulty associated with performing clinical trials in this field.

Gemcitabine or fluoropyrimidines, including 5-fluorouracil and S-1, are routinely used for BTC chemotherapy. The European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network guidelines published in 2009 recommend either gemcitabine-based or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeongsang Namdo
      • Jinju, Gyeongsang Namdo, Korea, Republic of, 660-702
        • Gyeongsang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age : older than 20
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
  • Histologically confirmed adenocarcinoma of the biliary tract
  • Metastatic or unresectable biliary cancer
  • No prior chemotherapy for biliary cancer
  • A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
  • Adequate bone marrow, liver, renal function

Exclusion Criteria:

  • A patient with no measurable disease
  • A patient who received previous palliative chemotherapy for biliary cancer
  • A patient who received adjuvant chemotherapy for biliary cancer within 1year
  • A patient with previous active or passive immunotherapy.
  • A pregnant or lactating patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gemcitabine/Cisplatin
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
Other Names:
  • Gemcitabine - Gemcitane
  • Cisplatin - Cispulan
Experimental: 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
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
Other Names:
  • S-1; TS-1
  • Cisplatin ; Cispulan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: From the assigned day to the disease progression or the last day of follow-up without progression. Clinically assessment would be done every cycle (month) and radiologically assessed every 6 weeks with CT scan
From the assigned day to the disease progression or the last day of follow-up without progression. Clinically assessment would be done every cycle (month) and radiologically assessed every 6 weeks with CT scan

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate Overall survival Safety profile
Time Frame: Overall survival is measured from the first day of assignment until death or the last day of the follow-up.Clinically assessment would be done every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan
Overall survival is measured from the first day of assignment until death or the last day of the follow-up.Clinically assessment would be done every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gyeongsang National University Hospital

Collaborators

Samsung Medical Center
Dong-A University
Chung-Ang University

Investigators

  • Principal Investigator: Hyuk-Chan Kwon, M.D., Dong-A University Hospital
  • Study Director: Jung Hun Kang, M.D., Gyeongsang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

March 31, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNUHIRB-2010-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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