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

NCT ID: NCT04093141

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2024-05-31

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.

Detailed Description

Patients with unresectable LAPC can be included in the study. Prior to inclusion, initial treatment with chemotherapy with or without radiation therapy (RT) is administered to all patients accord to the referring institutions protocol. Some patients will have undergone an attempted resection prior to inclusion. It is expected, that a substantial number of patients are participants in the LAPC-03 protocol (FOLFIRINOX followed by local therapy (resection, RT and/or IRE) in patients with LAPC).

After completion of initial therapy, potential study participants are restaged with a PET-CT scan and serum tumor markers. Patients found on restaging to be free of metastatic disease and without significant primary tumor progression will be candidates for IRE therapy. IRE therapy will be administered not earlier than 2 weeks after completion of initial therapy.

IRE will be done under general anesthesia as an in-patient procedure. Patients will attend study specific visits with PET-CT scan 3, 6, 9, 12, 18 and 24 months post-IRE. Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 15, 18, 21 and 24 months. During this we will monitor pain, quality of life, global functioning and nutritional status.

In patients who, at any time during the study, are assessed as candidates for resection, a more detailed re-evaluation of resectability is performed according to local preferences (e.g. EUS and/or LAP/LUS and/or CT and/or MR).

Conditions

Unresectable Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

IRE

Intervention Type: PROCEDURE

in situ irreversible electroporation

Interventions

IRE

in situ irreversible electroporation

Intervention Type: PROCEDURE

Other Intervention Names

irreversible electroporation

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery

OTHER

Sponsor Role: lead

Responsible Party

Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery

Professor of surgery, Consultant surgeon, DMSc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ole Thorlacius-Ussing, Professor, DMSc

Role: PRINCIPAL_INVESTIGATOR

Department of gastrointestinal surgery, Aalborg University Hospital

Locations

Aalborg University Hospital

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Rasmus Virenfeldt Flak, MD

Role: CONTACT

rasmus.virenfeldt@rn.dk

+4597661181

Mogens Tornby Stender, Consultant surgeon, PhD

Role: CONTACT

mogens.stender@rn.dk

+4597661761

Facility Contacts

Rasmus Virenfeldt Flak, MD

Role: primary

rasmus.virenfeldt@rn.dk

+4597661181

Mogens Tornby Stender, Consultant Surgeon, PhD

Role: backup

mogens.stender@rn.dk

+4597661761

Other Identifiers

N-20190013

Identifier Type: -

Identifier Source: org_study_id