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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT02208804
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Histopathologically confirmed diagnosis of adenocarcinoma of the colon or rectum
* Hepatic metastases with measurable morphological appearance (≥ 1 cm) on cross sectional imaging, located in the right and left hepatic arterial perfusion territory
* Unresectable, liver dominant disease
* Progressive disease after second line chemotherapy or no further chemotherapeutical treatment options due to severe side effects or unwillingness of the patient to undergo systemic chemotherapy
* Age ≥ 18 years
* Expected adequacy of follow-up
Exclusion Criteria:
* World health organization performance score \> 2
* Inadequate bone marrow function (hemoglobin \< 6.0 mmol/l, leukocyte count \< 3.0 x 109/l, platelet count \< 75x 109/l), inadequate liver function (bilirubin \> 35 µmol/l, aspartate aminotransferase / alanine aminotransferase (AST/ALT) \> 5 x upper limit of normal (ULN)) or inadequate renal function (creatinine \> 1.5 x ULN)
* Prior hemihepatectomy
* Compromised biliary system (biliary stent or hepaticojejunostomy)
* Child Pugh score B7 or worse
* Active hepatitis B or C
* Main portal vein thrombosis on CT (or previous portal vein embolization)
* Severe celiac axis stenosis on CT
* Unsuitable hepatic arterial anatomy on CT
* Treatment with systemic chemotherapy within 4 weeks prior to radioembolization
* Previous participation in a study classified as class III by a radiation safety committee
* Bleeding diathesis
* Pregnancy or breast feeding
* Life expectancy \< 3 months
* Patients who are declared incompetent
* Any condition that prevents from safe treatment with radioembolization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02208804
Study Brief:
Protocol Section:
NCT02208804