Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Electrochemotherapy is a type of electroporation that allows the delivery of drugs to the cells through the local creation of pores in the cell membrane. The electric pulses can be applied directly to the neoplastic cells, allowing for the local concentration of a possible chemotherapeutic agent administered through the bloodstream. This technique does not use heat nor other thermal energies and it is performed using special needles/electrodes linked to a generator (porator). In this study this technique will be applied on unresectable pancreatic cancer, already submitted to neoadjuvant treatment and still unresectable, through laparotomy. Bleomycin will be the chemotherapeutic agent.

Official Title
-----------------
A Clinical Trial Using Electrochemotherapy With Bleomycin for the Treatment of Non-metastatic Unresectable Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Device: Electrochemotherapy with Bleomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiologic confirmation of locally advanced pancreatic cancer by at least contrast enhanced CT of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol), performed maximum 4 weeks prior to the procedure Cytohistological diagnosis of pancreatic cancer Age > 18 and < 80 Stable disease after chemotherapy (no tumor progression, no oncomarkers (Carbohydrate Antigen 19-9 [CA 19-9] or Carcinoembryonic antigen [CEA]) increase Performance Status 0 sec. ECOG (Eastern Cooperative Oncology Group) Written informed consent Exclusion Criteria: Resectable pancreatic cancer as assessed by multidisciplinary meeting Stage IV disease Patients receiving fenitoin, phosphofenitoin or living vaccines Pregnancy Progressive disease (either dimensional and not only by stage) < 18 years old and > 80

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Electrochemotherapy with Bleomycin|Application of Reversible Electroporation (Electrochemotherapy) with Bleomycin|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of adverse events related with electrochemotherapy (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications are distinct in early (during hospitalization) and late (bile duct stenosis) that may appear during follow-up | through study completion, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Number of procedures planned actually performed | through study completion, 1 year | 
| Tumour response | Analysis of effects of electrochemotherapy on tumor using RECIST criteria | 12 months | 
| Quality of life | Analysis of quality of life using the Karnovsky performance index | 12 months | 
| Quality of life | Analysis of quality of life using the pain numeric scale | 12 months | 
| Survival | Survival analysis through the calculation of overall survival | 12 months | 
| Survival | Survival analysis through the calculation of progression free survival survival | 12 months | 
| Immunomonitoring | Study of adaptive immunity through the sampling of Interleukin6 and Heat shock protein 70 levels at baseline and post-procedure | From baseline to the first month |