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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Feasibility and translational analysis

Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis

Time frame
When 5 patients are included, the blood samples will be analysed for explorative analysis (expected after the first year). In all we expect to include 30 patients if positive results.

Secondary outcomes

1

Response Rate

According to RECIST 1.1

Time frame
6 months
2

Progression Free Survival

Time frame
3 years
3

Overall Survival

Time frame
3 years

Other outcomes

Sponsors and contacts

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