Irreversible Electroporation (IRE) for Treating Recurrent Pelvic Tumors (PELFIRE Study)

Amsterdam UMC, location VUmc27 enrolled

Overview

The goal of this single-center observational cohort study, based on a registry combining retrospectively and prospectively collected data, is to investigate the short- and long-term effects of irreversible electroporation (IRE) in men and women over the age of 18 who receive IRE for recurrence of pelvic tumors not suitable for other local treatment options such as surgery, thermal ablation, and radiotherapy. The main question it aims to answer is whether IRE is safe in this population, and secondarily, whether it is effective in controlling local tumor recurrence.

Retrospective data from December 2012 to April 2025, followed by prospective collection of new cases.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Carcinoma Renal Cancer Bladder Cancer Cervical Cancer Prostate Cancer Ovarian Cancer Lung Cancer (Including Metastatic Cancer)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Measurable disease described on pre-treatment imaging (CT/MRI/PET-CT) (max 6 weeks prior); * IRE of a recurrent pelvic tumor; * Unsuitable for other local therapies (surgery/stereotactic body radiation therapy) as described during the multidisciplinary tumor board; Exclusion Criteria: * If the treated tumor was biopsied directly prior to MWA and pathology proves the lesion to represent a benign entity; * Inadequate or insufficient data registered; * Inadequate or insufficient follow-up;

Outcomes

Primary Outcomes

Incidence and Severity of Adverse Events (CTCAE v5.0)

Safety of IRE, assessed by the rate and severity of adverse events per procedure and per patient, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame: Assessed up to 5 years.

Incidence and Classification of Nerve Injury (Seddon Classification)

Nerve injuries related to IRE, assessed per procedure and per patient, classified according to Seddon's classification as neurapraxia, axonotmesis, or neurotmesis.

Time frame: Assessed up to 5 years.

Secondary Outcomes

Overall survival (OS) per patient.

Overall survival is defined as the time from IRE procedure to the time of death due to any cause or to the last day of follow up (censored).

Time frame: Assessed up to 10 years

Progression-free survival (PFS; per patient analysis)

The time until the date of unequivocal disease progression (local site recurrence or metastatic disease) or death from any cause, whichever occurs first, assessed up to 10 years.

Time frame: Up to 10 years

Distant tumor progression-free survival (DPFS) per patient.

Distant tumor progression-free survival is defined as the time from randomization to the time of unequivocal distant tumor progression.

Time frame: 10 years

Local tumor progression-free survival (LTPFS) per patient and per tumor.

Local tumor progression-free survival is defined as the time from IRE procedure to the time of unequivocal local tumor progression.

Time frame: 10 years

Technical success

Proper placement and operation of the electrodes, the precise delivery of electrical pulses to the targeted tissue, and ensuring the parameters (such as voltage, pulse duration, and frequency) are correctly applied according to the protocol.

Time frame: IRE procedure duration (actual treatment phase): 30 minutes to 2 hours