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
- 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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie ECX (epirubicin, cisplatin, capecitabine) synergy in advanced gastric cancer?
How does ECX compare to CX in terms of overall survival and progression-free survival in NCT00743964?
Which biomarkers (e.g., HER2, microsatellite instability) predict response to ECX or CX in gastric cancer patients?
What are the key adverse events associated with epirubicin-based ECX versus CX in AGC trials?
Are there alternative triplet regimens to ECX for advanced gastric cancer with better safety profiles?
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center🇰🇷Seoul, Korea, Republic of