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Open Access 01-12-2015 | Study protocol

Colorectal liver metastatic disease: efficacy of irreversible electroporation—a single-arm phase II clinical trial (COLDFIRE-2 trial)

Authors: Hester J. Scheffer, Laurien G P H Vroomen, Karin Nielsen, Aukje A J M van Tilborg, Emile F I Comans, Cornelis van Kuijk, Bram B. van der Meijs, Janneke van den Bergh, Petrousjka M P van den Tol, Martijn R. Meijerink

Published in: BMC Cancer | Issue 1/2015

Abstract

Background

Irreversible electroporation (IRE) is a novel image-guided tumor ablation technique that has shown promise for the ablation of lesions in proximity to vital structures such as blood vessels and bile ducts. The primary aim of the COLDFIRE-2 trial is to investigate the efficacy of IRE for unresectable, centrally located colorectal liver metastases (CRLM). Secondary outcomes are safety, technical success, and the accuracy of contrast-enhanced (ce)CT and ¹⁸F-FDG PET-CT in the detection of local tumor progression (LTP).

Methods/design

In this single-arm, multicenter phase II clinical trial, twenty-nine patients with ¹⁸F-FDG PET-avid CRLM ≤ 3,5 cm will be prospectively included to undergo IRE of the respective lesion. All lesions must be unresectable and unsuitable for thermal ablation due to vicinity of vital structures. Technical success is based on ceMRI one day post-IRE. All complications related to the IRE procedure are registered. Follow-up consists of ¹⁸F-FDG PET-CT and 4-phase liver CT at 3-monthly intervals during the first year of follow-up. Treatment efficacy is defined as the percentage of tumors successfully eradicated 12 months after the initial IRE procedure based on clinical follow-up using both imaging modalities, tumor marker and (if available) histopathology. To determine the accuracy of ¹⁸F-FDG PET-CT and ceCT, both imaging modalities will be individually scored by two reviewers that are blinded for the final oncologic outcome.

Discussion

To date, patients with a central CRLM unsuitable for resection or thermal ablation have no curative treatment option and are given palliative chemotherapy. For these patients, IRE may prove a life-saving treatment option. The results of the proposed trial may represent an important step towards the implementation of IRE for central liver tumors in the clinical setting.

Trial registration

Trial registration number: NCT02082782.

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Title: Colorectal liver metastatic disease: efficacy of irreversible electroporation—a single-arm phase II clinical trial (COLDFIRE-2 trial)
Authors: Hester J. Scheffer
Laurien G P H Vroomen
Karin Nielsen
Aukje A J M van Tilborg
Emile F I Comans
Cornelis van Kuijk
Bram B. van der Meijs
Janneke van den Bergh
Petrousjka M P van den Tol
Martijn R. Meijerink
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: BMC Cancer / Issue 1/2015
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-015-1736-5

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Abstract

Background

Methods/design

Discussion

Trial registration

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