Investigating the feasibility of a clinical trial to test using irreversible electroporation to treat locally advanced pancreatic cancer following initial chemotherapy

Not Applicable

• Conditions: Malignant neoplasm of pancreas, locally advanced pancreas cancer; Cancer

• Registration Number: ISRCTN14986389
• Lead Sponsor: Royal Free London NHS Foundation Trust

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35551086/ (added 16/05/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-09
• Last Update Posted: 22 January 2024
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Able to provide informed consent
2. Aged =18 years
3. Locally advanced pancreatic cancer anywhere in the pancreas
3. Tissue confirmation of pancreatic adenocarcinoma by biopsy or cytology/pathology
4. Cancer not amenable to surgical resection (following pancreas surgeon/multidisciplinary team review)
5. Completed systemic chemotherapy with FOLFIRINOX (standard or modified ). This must be the only regimen of chemotherapy the patient has had since diagnosis.
6. Considered amenable to irreversible electroporation (IRE) therapy by pancreas interventional radiologist
7. WHO Performance status 0 or 1
8. Maximum cancer diameter 3.5 cm at the time of IRE treatment
9. Considered fit for general anaesthetic following pre-assessment.

Exclusion Criteria

1. First line chemotherapy other than FOLFIRINOX
2. Concomitant malignancy (except skin and prostate cancers)
3. Metastatic disease including distant (i.e. non-local) nodal metastases
4. Borderline resectable disease
5. Occlusion or >180° involvement of the portal vein (superior mesenteric vein/portal vein)
6. Arterial involvement with <180° of the superior mesenteric artery, celiac axis, or common hepatic artery
7. Untreated gastric outlet or biliary obstruction
8. Co-morbidity precluding general anaesthesia
9. Indwelling electrical devices such as pacemakers and Left Ventricular Assist Devices (LVADs)
10. Chronic Kidney Disease stage 3, 4, or 5
11. History of epilepsy or other neurological diseases
12. Abdominal varices preventing safe access to pancreas cancer
13. Unable to tolerate general anaesthetic with neuromuscular blockade
14. Subjects who are actively bleeding, anticoagulation which cannot be discontinued, coagulopathy defined as an international normalized ratio (INR) of =1.5, or have any one of the following haematology results:
14.1. Haemoglobin <8 g/dl
14.2. Absolute neutrophil count <1500 cells/ml
14.3. Platelet count <50,000.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Ability to recruit patients measured using the following from participant records at screening, randomisation, IRE visit (if allocated), restaging visit, surgery visit, follow up visits, end of treatment, and end of the study:<br>1.1. Rate of recruitment <br>1.2. Number of screening failures<br>1.3. Number of patients that complete the study pathway as per protocol<br>1.4. Rate of withdrawal from trial, the reasons why, and at which stage