Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

NCT03225781 | Terminated

• 1 other identifier: SP-ECT
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Feasibility

  through study completion, 1 year

• Tumour response

  12 months

• Quality of life

  12 months

• Quality of life

  12 months

• Survival

  12 months

Interventions

Electrochemotherapy with Bleomycin DEVICE

Application of Reversible Electroporation (Electrochemotherapy) with Bleomycin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead
• IGEA: collaborator

Study Sites (1)

University of Verona Hospital

Verona, 37134, Italy

Location

Related Publications (4)

• 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.

  PMID: 25917204 RESULT

• 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.

  PMID: 27069445 RESULT

• 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.

  PMID: 18987914 RESULT

• 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.

  PMID: 26029026 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Electrochemotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2017
• Study Start: July 1, 2017
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)