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:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT00172159
Eligibility Criteria:
Inclusion Criteria:
* 1\. colorectal cancer with primarily non-resectable hepatic metastasis, defined as (one of the following): (1) liver metastases \> five; (2) liver metastases are anatomically or functionally non-resectable (e.g. insufficient functional liver tissue, liver venous infiltration, liver arterial infiltration, …..) 2. No extra-hepatic disease 3. No prior chemotherapy, except adjuvant chemotherapy 4. Primary tumor resection \>1 month 5. Signed written informed consent 6. Male or female 18 - 75 years of age 7. Histologically confirmed adenocarcinoma of the colon or rectum 8. No extra-hepatic disease 9. Presence of at least one bi-dimensional indicator lesion measurable by CT scan or MRI not in an irradiated area 10. Life expectancy of \>= 3 months 11. Karnofsky performance status \>= 70% 12. Neutrophils \>= 1.5 x 109/L, platelets \>= 100 x 109/L, and hemoglobin \>= 9 g/dL 13. Bilirubin level \< 1.5 x ULN 14. ASAT and ALAT £ 2.5 x ULN (\<= 5 x ULN if liver metastasis are present) 15 Serum creatinine \< 1.5 x ULN 16. Effective contraception for both male and female patients if the risk of conception exists
Exclusion Criteria:
* 1\. Brain metastasis (known or suspected) 2. Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol 3. Any investigational agent(s) within 4 weeks prior to entry 4. Previous exposure to monoclonal antibodies, signal transduction inhibitors or other EGFR-targeting therapy 5. Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months 6. Acute or subacute intestinal occlusion or history of inflammatory bowel disease Known grade 3 or 4 allergic reaction to any of the components of the treatment 7. Known drug abuse/ alcohol abuse 8. Legal incapacity or limited legal capacity 9. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent 10. Women who are pregnant or breastfeeding 11. Clinically relevant peripheral neuropathy 12. Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for \>= 5 years will be allowed to enter the trial)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00172159
Study Brief:
Protocol Section:
NCT00172159