Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

Not Applicable

Terminated

• Conditions: Pancreatic Cancer

• Registration Number: NCT03225781
• Lead Sponsor: Universita di Verona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Status Verified: 2018-12
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	through study completion, 1 year	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Verona Hospital; 🇮🇹 Verona, Italy