ISRCTN72792659
Completed
Not Applicable
Prospective randomised phase II clinical trial of epirubicin, cisplatin, continuous infusional 5-fluorouracil (ECF) versus epirubicin, cisplatin and capecitabin (ECX) in patients with advanced gastric cancer
Ministry of Higher Education, Science and Technology (Slovenia)0 sites80 target enrollmentNovember 13, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ministry of Higher Education, Science and Technology (Slovenia)
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Both males and females, age 18 years or older
- •2\. Histologically confirmed advanced gastric cancer
- •3\. Performance status of 0\-2
- •4\. Adequate bone marrow function
- •5\. Adequate renal, hepatic function
- •7\. Normal cardiac function
- •8\. Estimated life expectancy more than 3 months
Exclusion Criteria
- •1\. Performance status more than 2
- •2\. Patients not recovered from operation
- •3\. Patients with unresolved intestinal obstruction
- •4\. Malabsorption syndrome
- •5\. Pregnancy
- •6\. Breastfeeding or childbearing potential without using adequate contraception
- •7\. Cardiovascular diseases (New York Heart Association \[NYHA] III\-IV)
- •8\. Impaired renal function
- •9\. Liver diseases
- •10\. Active hepatitis (hepatitis B, hepatitis C)
Outcomes
Primary Outcomes
Not specified
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