Clinical Trial

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

Study acronym: COLDFIRE-III
Recruiting Phase 2/3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-12-14.
Status change: Not Yet Recruiting → Recruiting 2024-08-21
Trial Details
NCT Number NCT06185556
Lead Sponsor Amsterdam UMC, location VUmc
Collaborators: Angiodynamics, Inc.
Conditions Colorectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer, Unresectable Solid Tumor
Enrollment 78 participants
Start Date 2024-08-20
Primary Completion 2029-09-01 (estimated)
Study Completion 2031-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-23