Inoperable liver metastases of colorectal cancer Cancer Malignant neoplasm of colon
Conditions
Interventions
The patients were randomised to either group A (XELIRI) or group B (FOLFIRI) (1:1 randomisation).
XELIRI regimen consisted of irinotecan (i.v.) 250 mg/m^2 given on Day 1 and capecitabine (oral) 1,00
Sponsors
Ministry of Higher Education, Science and Technology (Slovenia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the therapy, the following were assessed at baseline, 3 and 6 months, thereafter follow-up was every 3 months until progression of the disease (no limit on the maximum duration of follow-up): 1. Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) 2. Rate of radical surgical resection (R0 resection) | — |
Secondary
| Measure | Time frame |
|---|---|
| During the therapy, the following were assessed at baseline, 3 and 6 months, thereafter follow-up was every 3 months until progression of the disease (no limit on the maximum duration of follow-up): 1. Safety 2. Progression-free survival (PFS) 3. Overall survival (OS) | — |
Countries
Slovenia
Outcome results
None listed