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

Launched by AARHUS UNIVERSITY HOSPITAL · Jul 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Selective Internal Radiation Therapy (SIRT) using tiny radioactive beads (90Y resin microspheres) for patients with liver cancer caused by colorectal cancer that has not responded to previous treatments. The goal is to learn more about how this therapy works and its effects on the body by analyzing tissue and blood samples from participants.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with colorectal cancer that has spread primarily to the liver, with no other treatment options available. They should also have stopped certain cancer medications for specified periods before starting the trial. Participants can expect to undergo SIRT treatment, and their health will be monitored closely throughout the study. It's important to note that the trial is currently recruiting participants and aims to gather valuable information to help improve future treatments for similar conditions.

Gender

ALL

Eligibility criteria

• 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