AzTrials
AzTrials

Locally Advanced Pancreatic Carcinoma (LAPC)Phase 1/2PANFIRENCT01939665

PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma

A Phase 1/2 study testing NanoKnife "Irreversible electroporation (IRE)" in people with Locally Advanced Pancreatic Carcinoma (LAPC) and Non-metastasized Unresectable Pancreatic Carcinoma, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NanoKnife "Irreversible electroporation (IRE)"
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteNetherlands
Study dates
Sep 2013to Oct 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

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

Who may be able to join

  • Screening must be performed no longer than 2 weeks prior to study inclusion.
  • Radiologic confirmation of LAPC by at least ceCT of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol), performed maximum 2 weeks prior to the procedure;
  • Maximum tumor diameter ≤ 5 cm;
  • Histological or cytological confirmation of pancreatic adenocarcinoma;
  • Age ≥ 18 years;
  • ASA-classification 0 - 3
Show all 17Show fewer
  • Life expectancy of at least 12 weeks;
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion;
  • Hemoglobin ≥ 5.6 mmol/L;
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3;
  • Platelet count ≥ 100*109/l;
  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
  • ALT and AST ≤ 2.5 x ULN;
  • Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 ml/min;
  • Prothrombin time or INR < 1.5 x ULN;
  • Activated partial thromboplastin time < 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician);
  • Written informed consent;

Who cannot join

  • Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team;
  • Extrapancreatic metastases;
  • Successful down staging after (radio)chemotherapy from previous unresectable/borderline tumor to resectable tumor;
  • Stage IV pancreatic carcinoma;
  • History of epilepsy;
  • History of cardiac disease:
Show all 22Show fewer
  • Congestive heart failure >NYHA class 2;
  • Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening);
  • Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted);
  • Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
  • Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites);
  • Uncontrolled infections (> grade 2 NCI-CTC version 3.0);
  • Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment;
  • Immunotherapy ≤ 6 weeks prior to the procedure;
  • Chemotherapy ≤ 6 weeks prior to the procedure;
  • Radiotherapy ≤ 6 weeks prior to the procedure;
  • Concomitant use of anti-convulsive and anti-arrhythmic drugs (other than beta blockers used for antihypertensive);
  • Allergy to contrast media;
  • Any implanted stimulation device;
  • Any implanted metal stent/device within the area of ablation that cannot be removed;
  • Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study;
  • Of note, patients with contra-indications for MRI will not be excluded from participation: in this case radiologic follow-up will consist of CT-scanning according to protocol.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • VU University Medical Center

    Amsterdam, North Holland, 1081 HV

Other trials in Netherlands

About this study

Official title: PANFIRE - Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma - a Phase I Clinical Trial

Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.

The purpose of this study is to investigate the safety of percutaneous IRE in the treatment of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are feasibility and efficacy of IRE based upon symptomatic response and tumor response.

Read more

Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma (<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and ultrasound guidance. After IRE, patients will be carefully monitored and any (serious) adverse events are registered. Follow-up will consist of frequent CT scanning, as well as serum CA19.9 tumor marker.

We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor control, without causing severe complications.

Being tested
NanoKnife "Irreversible electroporation (IRE)"
Keywords
Locally advanced pancreatic carcinoma, LAPC, Irreversible electroporation, NanoKnife, IRE, Safety, Efficacy, Non-thermal ablation, Percutaneous ablation, Low Energy Direct Current
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • NanoKnife "Irreversible electroporation (IRE)"Device

    Also called IRE, NanoKnife

    Tumor ablation with irreversible electroporation with the NanoKnife

Study groups in NCT01939665
Study groupRoleWhat they receive
Irreversible electroporationExperimentalSingle arm study: Percutaneous irreversible electroporation of locally advanced pancreatic carcinoma
Receives: Device: NanoKnife "Irreversible electroporation (IRE)"

What is being measured

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

  1. Safety (number of adverse events)

    Number of adverse events of IRE-treatment (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications related to IRE are early complications during hospital admission (e.g. bile leak, bowel leak, infection, pancreatitis), or late complications of IRE such as bile duct stenosis that become apparent during follow-up in the year after treatment.

    Measured: early: 90 days; late: 12 months

Secondary outcomes (1)

  1. Tumor response

    • Ablation success: the ability to deliver the planned therapy and at 3 months to have no evidence of residual tumor;
    • Local recurrence rate (LRR): defined as the reappearance of viable tumor after a period of time during which viable tumor could not be detected;
    • Overall survival and (local and distant) progression-free survival.

    Measured: 12 months

Timeline

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

  1. First posted11 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01939665
Sponsor's protocol ID
NL42888.029.13
Other IDs
2013/155
Acronym
PANFIRE
Status last verified
Dec 2022
First submitted
3 Sep 2013
Last updated
20 Dec 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Ruarus AH, Vroomen LGPH, Geboers B, van Veldhuisen E, Puijk RS, Nieuwenhuizen S, Besselink MG, Zonderhuis BM, Kazemier G, de Gruijl TD, van Lienden KP, de Vries JJJ, Scheffer HJ, Meijerink MR. Percutaneous Irreversible Electroporation in Locally Advanced and Recurrent Pancreatic Cancer (PANFIRE-2): A Multicenter, Prospective, Single-Arm, Phase II Study. Radiology. 2020 Jan;294(1):212-220. doi: 10.1148/radiol.2019191109. Epub 2019 Nov 5.

    PubMed 31687922

  • Witvliet-van Nierop JE, Lochtenberg-Potjes CM, Wierdsma NJ, Scheffer HJ, Kazemier G, Ottens-Oussoren K, Meijerink MR, de van der Schueren MAE. Assessment of Nutritional Status, Digestion and Absorption, and Quality of Life in Patients with Locally Advanced Pancreatic Cancer. Gastroenterol Res Pract. 2017;2017:6193765. doi: 10.1155/2017/6193765. Epub 2017 Aug 20.

    PubMed 28912804

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NanoKnife "Irreversible electroporation (IRE)" in people with Locally Advanced Pancreatic Carcinoma (LAPC) and Non-metastasized Unresectable Pancreatic Carcinoma, 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 17 inclusion and 22 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: finished, as of the sponsor's last update on 20 Dec 2022. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (number of adverse events) (time frame: early: 90 days; late: 12 months). 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 NCT01939665, which also lists 2 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 20 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in