About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of patients with metastatic colorectal cancer with chemorefractory liver dominant disease. Patients are found not eligible for surgical resection, RFA or SBRT by a multidisciplinary tumour board (MDT), and considered candidates for SIRT treatment in order to obtain disease control or resectability.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Feasibility and translational analysis
Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis
Secondary outcomes
Response Rate
According to RECIST 1.1
Progression Free Survival
Overall Survival
Sponsors and contacts
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