Status:
RECRUITING
Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases
Lead Sponsor:
Aarhus University Hospital
Conditions:
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological sampl...
Detailed Description
In this study, the investigators seek to investigate biological aspects in patients with colorectal cancer liver metastasis undergoing treatment with Selective Internal Radiation Therapy, by translati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04491929
Start Date
November 1 2020
End Date
September 30 2028
Last Update
August 7 2024
Active Locations (1)
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1
Department of Oncology, Aarhus University Hospital
Aarhus N, Danmark, Denmark, 8200