A Randomized Study With Palliative Chemotherapy With or Without Local Treatment of Liver Metastases in Patients With Colo-rectal Cancer
Inclusion Criteria:
- Histologically verified adenocarcinoma of colon or rectum
- Ambulatory with an ECOG performance status 0-2
- At least 18 years of age
- Non-resectable liver metastases
- Progressive disease on or within 4 months after 1.line chemotherapy for KRAS mutant
or after 2.line chemotherapy in KRAS wild type patients
- 1-4 liver metastases with largest diameter of up to 6 cm on CT-scan
- Up to 20 lesions in liver with no more than 4 lesions larger than 4 cm
- The patients will start 2./3. line chemotherapy (KRAS mutant/KRAS wt)
- Laboratory values as the following:
- ANC ³ 1.5 x 109/L
- Platelets ³ 100 x 109/L
- Hb ³ 9g/dL
- Creatinine £ 2x upper limit of normal
- Bilirubin < 2.0x the upper limit of normal
- ASAT and ALAT £ 5x the upper limit of normal
- Albumin levels > 30 g/L
- INR<1.3
- Signed informed consent and expected cooperation of the patients for the
treatment and follow up must be obtained and documented according to ICH GCP, and
national/local regulations
Exclusion Criteria:
- Previous treatment with 2. or 3. line chemotherapy (KRAS mutant/KRAS wt)
- History of prior metastatic disease the last 3 years
- History of CNS or bone metastases
- Significant cardiac or other medical illness that would limit activity or survival,
such as severe congestive heart failure, unstable angina, or serious cardiac
arrhythmia
- Largest liver mets >6 cm, more than 4 liver lesions >4 cm
- Pulmonary mets>3 cm
- Lymph node mets >2.5 cm
- Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start
of treatment
- Any reason why, in the opinion of the investigator, the patient should not
participate.