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

Primary Purpose

Metastatic Biliary Tract Cancer, Locally Advanced Biliary Tract Cancer

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemcitabine, Cisplatin
S-1, Cisplatin
Sponsored by
Gyeongsang National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Biliary Tract Cancer focused on measuring Gemcitabine, Cisplatin, S-1, bile duct cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gyeongsang University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gemcitabine/Cisplatin

S-1/Cisplatin

Arm Description

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

Outcomes

Primary Outcome Measures

Time to progression

Secondary Outcome Measures

Response rate Overall survival Safety profile

Full Information

First Posted
March 30, 2010
Last Updated
June 21, 2011
Sponsor
Gyeongsang National University Hospital
Collaborators
Samsung Medical Center, Dong-A University, Chung-Ang University
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1. Study Identification

Unique Protocol Identification Number
NCT01096745
Brief Title
Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer
Official Title
Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
Planning for randomized phase III trial for this issue.
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Gyeongsang National University Hospital
Collaborators
Samsung Medical Center, Dong-A University, Chung-Ang University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Biliary Tract Cancer, Locally Advanced Biliary Tract Cancer
Keywords
Gemcitabine, Cisplatin, S-1, bile duct cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine/Cisplatin
Arm Type
Experimental
Arm Title
S-1/Cisplatin
Arm Type
Experimental
Arm Description
D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Cisplatin
Other Intervention Name(s)
Gemcitabine - Gemcitane, Cisplatin - Cispulan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
S-1, Cisplatin
Other Intervention Name(s)
S-1; TS-1, Cisplatin ; Cispulan
Intervention Description
D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyuk-Chan Kwon, M.D.
Organizational Affiliation
Dong-A University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jung Hun Kang, M.D.
Organizational Affiliation
Gyeongsang University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Gyeongsang University Hospital
City
Jinju
State/Province
Gyeongsang Namdo
ZIP/Postal Code
660-702
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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