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Clinical Trials/ISRCTN72792659
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.

Registry
who.int
Start Date
November 13, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ministry of Higher Education, Science and Technology (Slovenia)

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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