Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT01867918
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01867918
Study Brief:
Protocol Section:
NCT01867918