Colorectal cancer liver metastases
Conditions
Interventions
Scout and therapeutic doses of 166Ho-microspheres will be administered in the
hepatic artery during two sequential procedures on the same day. In all
subjects, the use of the ARC and the standard en
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria: * WHO (World health organization) performance score > 2 * Inadequate bone marrow function (hemoglobin 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the T/N activity concentration ratio. The primary endpoint will be compared between the ARC and standard micocatheter infusions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include mean absorbed doses of radioactivity in tumorous and healthy liver tissue, infusion efficiency, the predictive value of 166Ho-scout dose and tumor response. These enpoints will be compared between the ARC and standard micocatheter infusions. A dose-response relationship, clinical toxicity and overall survival will be assessed for the entire cohort. | — |
Countries
Netherlands
Outcome results
None listed