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Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Electrochemotherapy with Bleomycin
Sponsored by
Universita di Verona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Verona Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Feasibility
Number of procedures planned actually performed
Tumour response
Analysis of effects of electrochemotherapy on tumor using RECIST criteria
Quality of life
Analysis of quality of life using the Karnovsky performance index
Quality of life
Analysis of quality of life using the pain numeric scale
Survival
Survival analysis through the calculation of overall survival
Survival
Survival analysis through the calculation of progression free survival survival
Immunomonitoring
Study of adaptive immunity through the sampling of Interleukin6 and Heat shock protein 70 levels at baseline and post-procedure

Full Information

First Posted
July 17, 2017
Last Updated
December 21, 2018
Sponsor
Universita di Verona
Collaborators
IGEA
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1. Study Identification

Unique Protocol Identification Number
NCT03225781
Brief Title
Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer
Official Title
A Clinical Trial Using Electrochemotherapy With Bleomycin for the Treatment of Non-metastatic Unresectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Logistic reasons
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
Collaborators
IGEA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Electrochemotherapy with Bleomycin
Intervention Description
Application of Reversible Electroporation (Electrochemotherapy) with Bleomycin
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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
Time Frame
through study completion, 1 year
Secondary Outcome Measure Information:
Title
Feasibility
Description
Number of procedures planned actually performed
Time Frame
through study completion, 1 year
Title
Tumour response
Description
Analysis of effects of electrochemotherapy on tumor using RECIST criteria
Time Frame
12 months
Title
Quality of life
Description
Analysis of quality of life using the Karnovsky performance index
Time Frame
12 months
Title
Quality of life
Description
Analysis of quality of life using the pain numeric scale
Time Frame
12 months
Title
Survival
Description
Survival analysis through the calculation of overall survival
Time Frame
12 months
Title
Survival
Description
Survival analysis through the calculation of progression free survival survival
Time Frame
12 months
Title
Immunomonitoring
Description
Study of adaptive immunity through the sampling of Interleukin6 and Heat shock protein 70 levels at baseline and post-procedure
Time Frame
From baseline to the first month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Verona Hospital
City
Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25917204
Citation
Granata V, Fusco R, Piccirillo M, Palaia R, Petrillo A, Lastoria S, Izzo F. Electrochemotherapy in locally advanced pancreatic cancer: Preliminary results. Int J Surg. 2015 Jun;18:230-6. doi: 10.1016/j.ijsu.2015.04.055. Epub 2015 Apr 24.
Results Reference
result
PubMed Identifier
27069445
Citation
Bimonte S, Leongito M, Granata V, Barbieri A, Del Vecchio V, Falco M, Nasto A, Albino V, Piccirillo M, Palaia R, Amore A, Giacomo Rd, Lastoria S, Setola SV, Fusco R, Petrillo A, Izzo F. Electrochemotherapy in pancreatic adenocarcinoma treatment: pre-clinical and clinical studies. Radiol Oncol. 2016 Feb 16;50(1):14-20. doi: 10.1515/raon-2016-0003. eCollection 2016 Mar 1.
Results Reference
result
PubMed Identifier
18987914
Citation
Campana LG, Mocellin S, Basso M, Puccetti O, De Salvo GL, Chiarion-Sileni V, Vecchiato A, Corti L, Rossi CR, Nitti D. Bleomycin-based electrochemotherapy: clinical outcome from a single institution's experience with 52 patients. Ann Surg Oncol. 2009 Jan;16(1):191-9. doi: 10.1245/s10434-008-0204-8. Epub 2008 Nov 6.
Results Reference
result
PubMed Identifier
26029026
Citation
Girelli R, Prejano S, Cataldo I, Corbo V, Martini L, Scarpa A, Claudio B. Feasibility and safety of electrochemotherapy (ECT) in the pancreas: a pre-clinical investigation. Radiol Oncol. 2015 Mar 25;49(2):147-54. doi: 10.1515/raon-2015-0013. eCollection 2015 Jun.
Results Reference
result

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Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

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