Prospective randomised clinical trial phase II: 5-fluorouracil/folinic acid (5-FU/FA) and irinotecan versus combination cepecitabin and irinotecan in patients with metastatic colorectal cancer as first line treatment
- Conditions
- Inoperable liver metastases of colorectal cancerCancerMalignant neoplasm of colon
- Registration Number
- ISRCTN19912492
- Lead Sponsor
- Ministry of Higher Education, Science and Technology (Slovenia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1. Both males and females, age between 18-75 years
2. World Health Organization (WHO) performance status 0-1
3. Inoperable liver metastases of colorectal adenocarcinoma
4. No prior chemotherapy for metastatic disease
5. >6 months since adjuvant treatment
6. At least one measurable lesion visible on spiral computerised tomography (CT)
7. Adequate haematological, hepatic and renal function
1. Metastases outside of the liver
2. Local recurrence of colorectal cancer
3. Bilirubin >2 x upper limit of normal (ULN), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 x ULN
4. Clinical signs of cardiac decompensation
5. Ischaemic heart disease
6. Inflammatory bowel disease
7. History of other cancer
8. Participation in other study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method