NCT00743964
Completed
Phase 2
A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer
ConditionsAdvanced Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- Epirubicin
- Conditions
- Advanced Gastric Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Failure-free survival
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
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
Arms & Interventions
ECX
Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.
Intervention: Epirubicin
ECX
Epirubicin, cisplatin and capecitabine combination chemotherapy will be administered.
Intervention: Cisplatin, capecitabine
CX
Cisplatin and capecitabine combination chemotherapy will be administered.
Intervention: Cisplatin, capecitabine
Outcomes
Primary Outcomes
Failure-free survival
Time Frame: six months
Secondary Outcomes
- progression-free survival(six months)
Study Sites (1)
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