Using radiation therapy to treat liver metastases from colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.