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Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03225781
Recruitment Status : Terminated (Logistic reasons)
First Posted : July 21, 2017
Last Update Posted : December 26, 2018
Sponsor:
Collaborator:
IGEA
Information provided by (Responsible Party):
Salvatore Paiella, MD, 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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: Electrochemotherapy with Bleomycin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial Using Electrochemotherapy With Bleomycin for the Treatment of Non-metastatic Unresectable Pancreatic Cancer
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 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 :
  1. Feasibility [ Time Frame: through study completion, 1 year ]
    Number of procedures planned actually performed

  2. Tumour response [ Time Frame: 12 months ]
    Analysis of effects of electrochemotherapy on tumor using RECIST criteria

  3. Quality of life [ Time Frame: 12 months ]
    Analysis of quality of life using the Karnovsky performance index

  4. Quality of life [ Time Frame: 12 months ]
    Analysis of quality of life using the pain numeric scale

  5. Survival [ Time Frame: 12 months ]
    Survival analysis through the calculation of overall survival

  6. Survival [ Time Frame: 12 months ]
    Survival analysis through the calculation of progression free survival survival

  7. Immunomonitoring [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225781


Locations
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Italy
University of Verona Hospital
Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona
IGEA
Publications of Results:
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Responsible Party: Salvatore Paiella, MD, MD, Universita di Verona
ClinicalTrials.gov Identifier: NCT03225781    
Other Study ID Numbers: SP-ECT
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: December 26, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents