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NCT Number: NCT07782164

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

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.

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Key information

Conditions

Colorectal Carcinoma Adnexal Diseases Anal Cancer Anus Diseases Anus Neoplasms Bladder Cancer Cervical Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Cancer (Including Metastatic Cancer) Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasm Recurrence, Local Neoplasms Neoplasms by Site Neoplastic Processes Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Recurrence Renal Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1118 HV, Netherlands

Location status: Recruiting

Location contact

Danielle Vos, MD

CONTACT

[email protected]

020-4444444 ext. +31

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

irreversible electroporation

Procedure

Irreversible electroporation

Primary outcomes

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

    Time frame: Assessed up to 5 years.

    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.

  2. Incidence and Classification of Nerve Injury (Seddon Classification)

    Time frame: Assessed up to 5 years.

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

Secondary outcomes

  1. Overall survival (OS) per patient.

    Time frame: Assessed up to 10 years

    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).

  2. Progression-free survival (PFS; per patient analysis)

    Time frame: Up to 10 years

    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.

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

    Time frame: 10 years

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

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

    Time frame: 10 years

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

  5. Technical success

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

    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.

Other outcomes

  1. Length of Post-procedural Hospital Stay

    Time frame: From end of procedure to hospital discharge, assessed up to 30 days.

    Length of hospital stay following the IRE procedure, in days. Collected to descriptively explore potential associations with lesion and patient characteristics (e.g., lesion type, tumor location).

  2. Tumor markers

    Time frame: Baseline to 10 years

    Correlation between serum tumor marker levels (e.g., CA19-9, CEA) and radiological tumor response following IRE. Tumor marker dynamics will be explored as potential biomarkers for early treatment efficacy and recurrence.

Study contacts

Contact information is provided by the study sponsor or research team.

Sonia Triggiani, Radiologist

CONTACT

[email protected]

+393406763760 ext. +39

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

Irreversible Electroporation (IRE) of Recurrent Pelvic Tumors: the PELFIRE Study.

Acronym: PELFIRE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 24, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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