Phase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)

Phase 2

Completed

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: Epirubicin; Drug: Cisplatin, capecitabine

• Registration Number: NCT00743964
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECX	Epirubicin	Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.
ECX	Cisplatin, capecitabine	Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.
CX	Cisplatin, capecitabine	Cisplatin and capecitabine combination chemotherapy will be administered.

Primary Outcome Measures

Name	Time	Method
Failure-free survival	six months

Secondary Outcome Measures

Name	Time	Method
progression-free survival	six months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of