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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT01486251
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed diagnosis of CRC
* Measurable metastatic disease to the liver in proven disease progression (according to RECIST criteria) at baseline (within 4 weeks prior to study entry), with at least one lesion \> 2cm considered appropriate for DCE-US examination
* Previously exposed to at least, irinotecan, oxaliplatin and a fluoropyrimidine, all 3 administered at optimal doses, over one or two chemotherapy (CT) lines for metastatic disease with a clear resistance to these drugs. Previous exposure to bevacizumab and/or anti-EGFR monoclonal antibody is allowed.
* Age ≥18 years; Performance Status (PS) 0-2 and life expectancy \> 3 months.
* Adequate biological functions: Neutrophils ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Hemoglobin \> 9 g/dl; Creatinine clearance \> 30 ml/min (cockcroft \& Gault formula). Serum bilirubin \< 1,5 x the upper normal limit (UNL) and AST/ALT \< 5 x UNL.
* Signed written informed consent
* Female patients with childbearing potential (\<2 years after last menstruation) and male must use effective means of contraception during the study treatment and at least 6 months after the last study drug administration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01486251
Study Brief:
Protocol Section:
NCT01486251