Clinical trial NCT04093141: Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer
Official title: Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer (CHEMOFIRE-2)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unresectable Pancreatic Cancer
Keywords: locally advances pancreatic cancer
irreversible electroporation
nanoknife
phase II
efficacy
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients in the study will be compared to data from clinical registry.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: 2-year survival proportion from 1) diagnosis and 2) IRE
timeFrame: 2 years after the last patient is enrolled
Secondary outcomes:
measure: Median overall survival from 1) diagnosis and 2) IRE
timeFrame: 2 years after the last patient is enrolled
measure: Progression free survival after IRE
timeFrame: 2 years after the last patient is enrolled
measure: Median time to local progression after IRE
timeFrame: 2 years after the last patient is enrolled
measure: Median time to dissemination after IRE
timeFrame: 2 years after the last patient is enrolled
measure: 90-day complication rate and severity (Clavien-Dindo)
timeFrame: 90 days after the last patient is enrolled
measure: Resection rate
timeFrame: 2 years after the last patient is enrolled
measure: Quality of life (EORTC QLQ C-30)
timeFrame: Every 3 months for 2 years after the intervention
measure: Perioperative pain perception (VAS)
timeFrame: Every week for 1 month after the intervention
measure: Long term pain perception (m-BPI-SF)
timeFrame: Every 3 months for 2 years after the intervention
measure: ECOG performance status
timeFrame: Every 3 months for 2 years after the intervention
measure: Nutritional status assessment (PG-SGA-SF)
timeFrame: Every 3 months for 2 years after the intervention
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Department of gastrointestinal surgery, Aalborg University Hospital
name: Ole Thorlacius-Ussing, Professor, DMSc
role: PRINCIPAL_INVESTIGATOR
References: