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

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

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions3

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