Using radiation therapy to treat liver metastases from colorectal cancer
Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study
This study is testing how well Selective Internal Radiation Therapy works for patients with liver cancer that started from colorectal cancer by looking at changes in their blood before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Aarhus N, Danmark) |
| Trial ID | NCT04491929 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the biological aspects of patients with liver metastases from colorectal cancer who are undergoing Selective Internal Radiation Therapy (SIRT). The study involves collecting and analyzing blood samples before and after treatment to quantify cell-free DNA and identify tumor-specific mutations. The aim is to understand the relationship between these biological markers and patient outcomes. Up to 30 patients will be included in this feasibility study conducted at Aarhus University Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with metastatic colorectal adenocarcinoma and liver-dominant disease that is not amenable to surgical resection or other local therapies.
Not a fit: Patients with detectable extrahepatic disease or those who have not met the pre-treatment criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the biological behavior of liver metastases and improve treatment strategies for colorectal cancer patients.
How similar studies have performed: While this approach is observational and focuses on biological analysis, similar studies using SIRT have shown promise in treating liver metastases, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus N, Danmark
- Department of Oncology, Aarhus University Hospital — Aarhus N, Danmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Louise B Callesen — Experimental Clinical Oncology
- Study coordinator: Louise B Callesen, MD
- Email: louicall@rm.dk
- Phone: +4578462535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.