RecruitingPhase 2Phase 3NCT06185556

COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases

COLDFIRE-III Trial: Perivascular and Peribiliary Colorectal Liver Metastases (0-5cm): Irreversible Electroporation Versus Stereotactic Body Radiotherapy


Sponsor

Amsterdam UMC, location VUmc

Enrollment

78 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this phase IIb/III, prospective, randomized clinical trial is to compare the efficacy of irreversible electroporation (IRE) with stereotactic body radiotherapy (SBRT) in patients with perivascular or peribiliary colorectal liver metastases (CRLM), that are not amenable for surgical resection or thermal ablation. Efficacy is assessed in terms of local control at 2 years.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (COLDFIRE-III) tests a combination of two treatments — irreversible electroporation (a non-heat-based tumor destruction technique) and stereotactic body radiotherapy (highly targeted radiation) — for people with colorectal cancer that has spread to the liver in locations that are too close to blood vessels or bile ducts for standard surgery or heat-based ablation. **You may be eligible if...** - You have been diagnosed with colorectal cancer that has spread to your liver (1–3 spots, each up to 5 cm) - Your liver spots cannot be removed surgically or treated with heat ablation because of their location near blood vessels or bile ducts - You have had prior treatment for colorectal cancer - You may have a limited number of additional liver spots that are treatable separately **You may NOT be eligible if...** - You have more than 10 liver spots total - Your cancer has spread widely beyond the liver and is uncontrolled - You have serious heart or clotting disorders - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIrreversible electroporation

Percutaneous (CT-guided) irreversible electroporation of 1-3 perivascular and peribiliary colorectal liver metastasis.

RADIATIONStereotactic body radiotherapy

Stereotactic body radiotherapy (CT- or MRI-guided) of 1-3 perivascular and peribiliary colorectal liver metastases.


Locations(1)

Amsterdam UMC - location VUmc

Amsterdam, North Holland, Netherlands

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NCT06185556


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