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Colorectal CarcinomaPELFIRENCT07782164

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

An observational study of Colorectal Carcinoma and Renal Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Carcinoma, Renal Cancer, Bladder Cancer
What is being tested?
Irreversible electroporation
Type of treatment
Surgery or procedure
How many people
27 participants
Where
1 siteNetherlands
Study dates
18 Apr 2025to Jul 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients treated with irreversible electroporation (IRE) for recurrent pelvic tumors at Amsterdam UMC starting from December 2012, identified from a dedicated institutional registry. Patients had recurrent pelvic disease not amenable to other local treatment options (surgery, stereotactic body radiotherapy, or thermal ablation), as determined by a multidisciplinary tumor board including medical oncology, radiation oncology, surgical oncology, diagnostic and interventional radiology, and pathology.

Who may be able to join

  • 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;

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sonia Triggiani, Radiologist contact

+393406763760 ext. +39

sonia.triggiani@policlinico.mi.it

Netherlands1 site, 1 recruiting

  • Amsterdam UMC

    Amsterdam, North Holland, 1118 HV

    Danielle Vos, MD, 020-4444444 ext. +31, interventieradiologie@amsterdamumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Irreversible Electroporation (IRE) of Recurrent Pelvic Tumors: the 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.

Read the detailed description

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

Being tested
Irreversible electroporation
Keywords
Irreversible electroporation (IRE), Colorectal Carcinoma, Local treatment, Tumor Ablation, Neoplasm Recurrence, Pelvic Tumor Recurrence
Medical subject headings
Colorectal Neoplasms, Kidney Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Prostatic Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irreversible electroporationProcedure or surgery

    Irreversible electroporation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessed up to 5 years.

  2. 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.

    Measured: Assessed up to 5 years.

Secondary outcomes (5)

  1. 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).

    Measured: Assessed up to 10 years

  2. 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.

    Measured: Up to 10 years

  3. 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.

    Measured: 10 years

  4. 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.

    Measured: 10 years

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2026
  2. Study start18 Apr 2025
  3. Primary completionJun 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
27 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07782164
Sponsor's protocol ID
2025.0233
Acronym
PELFIRE
Status last verified
Aug 2026
First submitted
8 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Luo X, Qin Z, Tao H, Shi J, Fang G, Li Z, Zhou X, Chen J, Xu K, Zeng J, Niu L. The Safety of Irreversible Electroporation on Nerves Adjacent to Treated Tumors. World Neurosurg. 2017 Dec;108:642-649. doi: 10.1016/j.wneu.2017.09.049. Epub 2017 Sep 18.

    PubMed 28927918

  • Schoellnast H, Monette S, Ezell PC, Maybody M, Erinjeri JP, Stubblefield MD, Single G, Solomon SB. The delayed effects of irreversible electroporation ablation on nerves. Eur Radiol. 2013 Feb;23(2):375-80. doi: 10.1007/s00330-012-2610-3. Epub 2012 Aug 16.

    PubMed 23011210

  • Narayanan G, Mahendra AM, Gentile NT, Schiro BJ, Gandhi RT, Pena CS, Dijkstra M. Safety and Effectiveness of Irreversible Electroporation in Lymph Node Metastases. Cardiovasc Intervent Radiol. 2024 Aug;47(8):1066-1073. doi: 10.1007/s00270-024-03795-w. Epub 2024 Jun 28.

    PubMed 38943032

  • Seddon HJ. A Classification of Nerve Injuries. Br Med J. 1942 Aug 29;2(4260):237-9. doi: 10.1136/bmj.2.4260.237. No abstract available.

    PubMed 20784403

  • van den Bos W, Scheffer HJ, Vogel JA, Wagstaff PG, de Bruin DM, de Jong MC, van Gemert MJ, de la Rosette JJ, Meijerink MR, Klaessens JH, Verdaasdonk RM. Thermal Energy during Irreversible Electroporation and the Influence of Different Ablation Parameters. J Vasc Interv Radiol. 2016 Mar;27(3):433-43. doi: 10.1016/j.jvir.2015.10.020. Epub 2015 Dec 17.

    PubMed 26703782

  • Scheffer HJ, Nielsen K, de Jong MC, van Tilborg AA, Vieveen JM, Bouwman AR, Meijer S, van Kuijk C, van den Tol PM, Meijerink MR. Irreversible electroporation for nonthermal tumor ablation in the clinical setting: a systematic review of safety and efficacy. J Vasc Interv Radiol. 2014 Jul;25(7):997-1011; quiz 1011. doi: 10.1016/j.jvir.2014.01.028. Epub 2014 Mar 18.

    PubMed 24656178

  • Vroomen LGPH, Scheffer HJ, Melenhorst MCAM, van Grieken N, van den Tol MP, Meijerink MR. Irreversible Electroporation to Treat Malignant Tumor Recurrences Within the Pelvic Cavity: A Case Series. Cardiovasc Intervent Radiol. 2017 Oct;40(10):1631-1640. doi: 10.1007/s00270-017-1657-6. Epub 2017 May 3.

    PubMed 28470395

  • Niessen C, Jung EM, Schreyer AG, Wohlgemuth WA, Trabold B, Hahn J, Rechenmacher M, Stroszczynski C, Wiggermann P. Palliative treatment of presacral recurrence of endometrial cancer using irreversible electroporation: a case report. J Med Case Rep. 2013 May 13;7:128. doi: 10.1186/1752-1947-7-128.

    PubMed 23668891

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Carcinoma and Renal Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sonia Triggiani, Radiologist (+393406763760 ext. +39, sonia.triggiani@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Adverse Events (CTCAE v5.0) (time frame: Assessed up to 5 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07782164, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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