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

Unresectable Pancreatic Cancer Clinical Trial

— CHEMOFIRE-2  

Official title:

Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer (CHEMOFIRE-2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04093141
• Other study ID #: N-20190013
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 2024

Study information

• Verified date: March 2021
• Source: Aalborg University Hospital
• Contact: Rasmus Virenfeldt Flak, MD
• Phone: +4597661181
• Email: rasmus.virenfeldt[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Unresectable Pancreatic Cancer

Intervention

Procedure:
• IRE
in situ irreversible electroporation

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year survival proportion from 1) diagnosis and 2) IRE		2 years after the last patient is enrolled
Secondary	Median overall survival from 1) diagnosis and 2) IRE		2 years after the last patient is enrolled
Secondary	Progression free survival after IRE		2 years after the last patient is enrolled
Secondary	Median time to local progression after IRE		2 years after the last patient is enrolled
Secondary	Median time to dissemination after IRE		2 years after the last patient is enrolled
Secondary	90-day complication rate and severity (Clavien-Dindo)		90 days after the last patient is enrolled
Secondary	Resection rate		2 years after the last patient is enrolled
Secondary	Quality of life (EORTC QLQ C-30)	Quality of life questionnaire - Core 30 is used to assess the quality of life in the included patients. Raw scores will be calculated according to the manual. Items will be grouped in: Global health status (range 0 - 100, high is good), Functional scales (range 0 - 100, high is good) and symptom scales (range 0 - 100 low is good). Differences in each scales during the course of the trial we be calculated seperately.	Every 3 months for 2 years after the intervention
Secondary	Perioperative pain perception (VAS)	Perioperative pain will be scores using the visual analogue pain scale (range 0 - 10, low score is less pain).	Every week for 1 month after the intervention
Secondary	Long term pain perception (m-BPI-SF)	Long term pain will be assessed using the modified Danish version of the Brief Pain Inventory - short form. The outcomes assessed will be an average score of pain severity items and interference items in accordance with the manual. The scales range from 0 to 10 (lower is less pain).	Every 3 months for 2 years after the intervention
Secondary	ECOG performance status	Physicians assessment of global functioning using the "Eastern Cooperative Oncology Group" perfomance status scale (range 0 - 5, low score is better)	Every 3 months for 2 years after the intervention
Secondary	Nutritional status assessment (PG-SGA-SF)	Nutritional status assessment using the Scored Patient-Generated Subjective Global Assessment (short form). The short form includes only patient reported measures and will be combined into a single score according to the manual (range 0 - 37,low score is better).	Every 3 months for 2 years after the intervention