Electrochemotherapy of Posterior Resection Surface for Lowering Disease

Status Terminated

Clinical Trial Summary

The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy (ECT) with bleomycin in pancreatic cancer in clinical study phase I and II. After surgical resection of pancreatic cancer, the posterior resection surface will be treated with ECT with the intention to lower disease recurrence rate. The study will include 20 patients in phase I clinical study and additional 20 patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria. Treatment effectiveness will be evaluated by US or CT imaging, to detect early local recurrence of the disease. Long term effectiveness of the treatment will be evaluated by frequent and precise patient follow-up. During follow-up clinical examination, laboratory tests, tumor markers (Ca 19-9 and CEA) and US/CT imaging will be performed. The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.

Clinical Trial Description

The study will be conducted on patients with resectable pancreatic cancer. 20 patients will be included in phase I clinical study and additional 20 patients in phase II clinical study (or in the extension of the clinical study). After surgical resection of pancreatic cancer, the posterior resection surface will be treated with purpose to lower disease recurrence rate. Plate electrodes will be used for ECT treatment, the electrodes will be placed between choledochal cut-end, truncus celiacus, remaining of the pancreas and aortal lymph nodes. ECT will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2). Triggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart. All patients will be treated after the procedure has been thoroughly described to them and have signed informed consent. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04281290
Study type	Interventional
Source	University Medical Centre Ljubljana
Contact
Status	Terminated
Phase	Phase 1
Start date	July 13, 2020
Completion date	March 9, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study) — PanECT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms