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

Study acronym: COLDFIRE-III
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary completion date: Feb 2029 to Sep 1, 2029
    • Start date changed from estimate of Mar 2024 to Aug 20, 2024
    • Enrollment target: 96 to 78
    • Study sites: 0 to 1
    • Study completion date: Feb 2031 to Sep 1, 2031
    • Study description expanded, about 28 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06185556
Lead Sponsor Amsterdam UMC, location VUmc
Collaborators: Angiodynamics, Inc.
Conditions
(from sponsor)		 Colorectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer, Unresectable Solid Tumor
Related terms Colorectal Neoplasms
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov