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Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

NCT ID: NCT03225781

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-12-21

Brief Summary

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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

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Electrochemotherapy with Bleomycin

Application of Reversible Electroporation (Electrochemotherapy) with Bleomycin

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IGEA

INDUSTRY

Sponsor Role collaborator

Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Salvatore Paiella, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Verona Hospital

Verona, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 25917204 (View on PubMed)

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.

Reference Type RESULT
PMID: 27069445 (View on PubMed)

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.

Reference Type RESULT
PMID: 18987914 (View on PubMed)

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.

Reference Type RESULT
PMID: 26029026 (View on PubMed)

Other Identifiers

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SP-ECT

Identifier Type: -

Identifier Source: org_study_id