Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03225781
• Other study ID #: SP-ECT
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 21, 2018

Study information

• Verified date: December 2018
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• Electrochemotherapy with Bleomycin
Application of Reversible Electroporation (Electrochemotherapy) with Bleomycin

Locations

Country	Name	City	State
Italy	University of Verona Hospital	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Universita di Verona	IGEA

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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-clini — View 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;1 — View Citation

Girelli R, Prejanò 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 2 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility	Number of procedures planned actually performed	through study completion, 1 year
Secondary	Tumour response	Analysis of effects of electrochemotherapy on tumor using RECIST criteria	12 months
Secondary	Quality of life	Analysis of quality of life using the Karnovsky performance index	12 months
Secondary	Quality of life	Analysis of quality of life using the pain numeric scale	12 months
Secondary	Survival	Survival analysis through the calculation of overall survival	12 months
Secondary	Survival	Survival analysis through the calculation of progression free survival survival	12 months
Secondary	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