A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer
Phase 2
N/A
75 Years
N/A
75 Years
Not Enrolling
Both
Advanced Gastric Cancer
Both
Advanced Gastric Cancer
Trial Information
A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Failure-free survival
Outcome Time Frame:
six months
Safety Issue:
No
Authority:
Korea: Food and Drug Administration
Study ID:
SMC IRB 2008-04-027
NCT ID:
NCT00743964
Start Date:
April 2008
Completion Date:
October 2009
Related Keywords:
- Advanced Gastric Cancer
- Stomach Neoplasms
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