Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oslo University Hospital
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
