RecruitingNCT04491929

Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases

Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study

Sponsor

Aarhus University Hospital

Enrollment

30 participants

Start Date

Nov 1, 2020

Study Type

OBSERVATIONAL

Conditions

Liver Metastasis Colon Cancer

Summary

Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

Diagnosis of metastatic colorectal adenocarcinoma with liver dominant disease
Diagnosis of liver metastasis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
The Liver metastasis are not eligible for resection, RFA or SBRT
All patients must be off all chemotherapeutic regimens for 14 days prior to SIRT treatment
All patients must be off vascular endothelial growth factor inhibitors for 6 weeks prior to SIRT treatment
Progressive disease, severe intolerance during or following all standard lines of chemo-therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Age 18 years or older
Able to understand written information
Consent to samples for translational research

Exclusion Criteria11

Pretherapeutic work-up procedure with Tc-99m macroaggregated albumin (MAA) scintigraphy showing extrahepatic foci in GI-tract
Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition
Previous radiation therapy to the lungs and/or to the upper abdomen overlapping with dose to the liver at interventionist´s decision
Lung shunt greater than 20% or \> 30 Gray radiation absorbed dose to the lungs, at estimated by Tc-99m-MAA
Pregnancy
Symptomatic lung disease precluding SIRT at interventionist´s decision
Active uncontrolled infection
Any pre-treatment laboratory findings within 30 days of treatment demonstrating: alanine aminotransferase level greater than 5 times upper normal limit and/or serum bilirubin greater than 2 mg/dl (\>34 umol/l)
Current or previously evidence of ascites on CT-scan or physical examination
Tumour volume greater than 50% of liver volume
Conditions precluding translational samples