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

Liver Metastasis Colon Cancer Clinical Trial

— SIRT  

Official title:

Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04491929
• Other study ID #: 1-10-72-111-20
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: September 30, 2028

Study information

• Verified date: July 2023
• Source: Aarhus University Hospital
• Contact: Louise B Callesen, MD
• Phone: +4578462535
• Email: louicall[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 translational analysis of biological samples.

SIRT will be conducted as per standard procedure at Aarhus University Hospital. Translational blood samples will be drawn pre-treatment and during follow up.

The total cell free DNA level will be quantified in all samples. The samples will be analysed for tumour specific mutations such as the KRAS, BRAF and NRAS oncogenes.

The investigators expect to include up to 30 patients.

This is a purely observational translational study. Results will be analysed in relation to outcome data.

The study is conducted in collaboration with:

Department of Gastroenterology and Hepatology, Aarhus University Hospital Department of Radiology, Aarhus University Hospital Department of Nuclear Medicine, Aarhus University Hospital

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2028
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Liver Metastasis Colon Cancer
• Liver Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aarhus University Hospital	Aarhus N	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and translational analysis	Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis	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	Response Rate	According to RECIST 1.1	6 months
Secondary	Progression Free Survival		3 years
Secondary	Overall Survival		3 years