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Clinical Trial
. 2015 Oct 24:15:772.
doi: 10.1186/s12885-015-1736-5.

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

Hester J Scheffer  1 , Laurien G P H Vroomen  2 , Karin Nielsen  3 , Aukje A J M van Tilborg  4 , Emile F I Comans  5 , Cornelis van Kuijk  6 , Bram B van der Meijs  7 , Janneke van den Bergh  8 , Petrousjka M P van den Tol  9 , Martijn R Meijerink  10
Affiliations
Clinical Trial

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

Hester J Scheffer et al. BMC Cancer. .

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 (18)F-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 (18)F-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 (18)F-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 (18)F-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 number: NCT02082782.

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Figures

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Fig. 1
Flow diagram of study procedure
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References

    1. Rempp H, Boss A, Helmberger T, Pereira P. The current role of minimally invasive therapies in the management of liver tumors. Abdom Imaging. 2011;36:635–47. doi: 10.1007/s00261-011-9749-2. - DOI - PubMed
    1. Abdalla EK, Vauthey J-N, Ellis LM, Ellis V, Pollock R, Broglio KR, Hess K, Curley SA. Recurrence and outcomes following hepatic resection, radiofrequency ablation, and combined resection/ablation for colorectal liver metastases. Ann Surg Oncol. 2004;239:818–25. doi: 10.1097/01.sla.0000128305.90650.71. - DOI - PMC - PubMed
    1. Gleisner A, Choti MA, Assumpcao L, Nathan H, Schulick R, Pawlik T. Recurrence and survival following hepatic resection, radiofrequency ablation, and combined resection-radiofrequency ablation. Arch Surg. 2014;143:1204–1212. doi: 10.1001/archsurg.143.12.1204. - DOI - PubMed
    1. De Baere T, Elias D, Dromain C, Gamal El Din M, Kuoch V, Ducreux M, Boige V, Lassau N, Marteau V, Lasser P, Roche A. Hepatic Metastases with a Mean Follow-Up of More Than 1 Year. AJR Am J Roentgenol. 2000;175(December):1619–1625. doi: 10.2214/ajr.175.6.1751619. - DOI - PubMed
    1. Cannon R, Ellis S, Hayes D, Narayanan G, Martin RCG. Safety and early efficacy of irreversible electroporation for hepatic tumors in proximity to vital structures. J Surg Oncol. 2012;107(October):544–9. - PubMed

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