Back to resultsPhase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)
Primary Purpose
Advanced Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Epirubicin
Cisplatin, capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Aged 75 years or less
- Adenocarcinoma of stomach
- Advanced, metastatic, or recurrent
- No prio chemotherapy for advanced disease
- Adequate performance status
- Adequate major organ functions
Exclusion Criteria:
- Severe comorbid illness or active infections
- Pregnancy or lactating women
- GI obstruction or malabsorption syndrome
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ECX
CX
Arm Description
Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.
Cisplatin and capecitabine combination chemotherapy will be administered.
Outcomes
Primary Outcome Measures
Failure-free survival
Secondary Outcome Measures
progression-free survival
Full Information
NCT ID
NCT00743964
First Posted
August 27, 2008
Last Updated
January 13, 2010
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00743964
Brief Title
Phase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)
Official Title
A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (AGC). The objective of the study is to evaluate the safety and activity of ECX and CX combination chemotherapy given as first-line therapy for AGC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECX
Arm Type
Experimental
Arm Description
Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.
Arm Title
CX
Arm Type
Active Comparator
Arm Description
Cisplatin and capecitabine combination chemotherapy will be administered.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
Epirubicin 50 mg/m2 iv on day 1
Intervention Type
Drug
Intervention Name(s)
Cisplatin, capecitabine
Intervention Description
Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.
Primary Outcome Measure Information:
Title
Failure-free survival
Time Frame
six months
Secondary Outcome Measure Information:
Title
progression-free survival
Time Frame
six months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 75 years or less
Adenocarcinoma of stomach
Advanced, metastatic, or recurrent
No prio chemotherapy for advanced disease
Adequate performance status
Adequate major organ functions
Exclusion Criteria:
Severe comorbid illness or active infections
Pregnancy or lactating women
GI obstruction or malabsorption syndrome
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135 710
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
20060288
Citation
Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, Kang WK. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010 Mar;46(5):885-91. doi: 10.1016/j.ejca.2009.12.015. Epub 2010 Jan 7.
Results Reference
derived
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Phase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)
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