Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer

NCT04093141 | Unknown FDA Device

• 1 other identifier: N-20190013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm clinical trial of irreversible electroporation (IRE) for the treatment of unresectable locally advanced pancreatic cancer (LAPC). The aim of the study is to evaluate the efficacy of IRE in this patient group. A statistical analysis of patient survival will be performed, comparing study participants to historical data from the Danish national database of pancreatic cancer patients.

Conditions

Unresectable Pancreatic Cancer

Keywords

locally advances pancreatic cancer; irreversible electroporation; nanoknife; phase II; efficacy

Outcome Measures

Primary Outcomes (1)

• 2-year survival proportion from 1) diagnosis and 2) IRE

  2 years after the last patient is enrolled

Secondary Outcomes (11)

• Median overall survival from 1) diagnosis and 2) IRE

  2 years after the last patient is enrolled

• Progression free survival after IRE

  2 years after the last patient is enrolled

• Median time to local progression after IRE

  2 years after the last patient is enrolled

• Median time to dissemination after IRE

  2 years after the last patient is enrolled

• 90-day complication rate and severity (Clavien-Dindo)

  90 days after the last patient is enrolled

Study Arms (1)

Intervention

EXPERIMENTAL

Procedure: IRE

Interventions

IRE PROCEDURE

in situ irreversible electroporation

Also known as: irreversible electroporation

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytologically proven adenocarcinoma/carcinoma of the pancreas.
• Largest tumor diameter ≤4 cm in any plane.
• \>18 years of age.
• Prior treatment with neoadjuvant chemotherapy for at least 2 months
• Tumor must be deemed as unresectable at the national pancreatic multidisciplinary team conference after neoadjuvant treatment.
• Non-progressive disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECiST 1.1) after neoadjuvant treatment.
• Patients must be able to give informed consent.

You may not qualify if:

• Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative ultrasound).
• ASA score \>3
• ECOG performance status \>2
• Pregnancy.
• Atrial fibrillation.
• Implanted electronic device e.g. cardiac pacemakers or other electrostimulators.
• Metal stents or other metallic objects near the ablation zone (unless the stent can be replaced with a plastic stent prior to IRE).
• Signs of severe disease of the bone marrow, kidney or liver during time of treatment. Treatment may be postponed if the disease state is reversible.
• Severe allergies to anesthetic agent, paralytic agent or any of the equipment used during treatment.
• Patient is referred from hospital outside of Denmark

Sponsors & Collaborators

• Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

MeSH Terms

Interventions

Electroporation

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Ole Thorlacius-Ussing, Professor, DMSc

  Department of gastrointestinal surgery, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasmus Virenfeldt Flak, MD

CONTACT

+4597661181; rasmus.virenfeldt@rn.dk

Mogens Tornby Stender, Consultant surgeon, PhD

CONTACT

+4597661761; mogens.stender@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of surgery, Consultant surgeon, DMSc

Model Details: Patients in the study will be compared to data from clinical registry.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: September 17, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2024
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)