Status:
UNKNOWN
Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer
Lead Sponsor:
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Conditions:
Unresectable Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ef...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04093141
Start Date
May 1 2019
End Date
May 1 2024
Last Update
April 1 2021
Active Locations (1)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000