Phase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)
NCT ID: NCT00743964
Last Updated: 2010-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2008-04-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ECX
Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.
Epirubicin
Epirubicin 50 mg/m2 iv on day 1
Cisplatin, capecitabine
Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.
CX
Cisplatin and capecitabine combination chemotherapy will be administered.
Cisplatin, capecitabine
Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.
Interventions
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Epirubicin
Epirubicin 50 mg/m2 iv on day 1
Cisplatin, capecitabine
Cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Capecitabine 2000 mg/m2 on days 1 to 14.
Eligibility Criteria
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Inclusion Criteria
* Adenocarcinoma of stomach
* Advanced, metastatic, or recurrent
* No prio chemotherapy for advanced disease
* Adequate performance status
* Adequate major organ functions
Exclusion Criteria
* Pregnancy or lactating women
* GI obstruction or malabsorption syndrome
75 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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01-9-0804027
Identifier Type: -
Identifier Source: secondary_id
SMC IRB 2008-04-027
Identifier Type: -
Identifier Source: org_study_id
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