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

Completed

• Conditions: Advanced gastric cancer; Cancer; Malignant neoplasm of stomach

• Registration Number: ISRCTN72792659
• Lead Sponsor: Ministry of Higher Education, Science and Technology (Slovenia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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)
11. HIV positive
12. Other active infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified