Pancreatic Cancer
Conditions
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.
Interventions
Application of Reversible Electroporation (Electrochemotherapy) with Bleomycin
Sponsors
IGEA
Universita di Verona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | through study completion, 1 year | Number of procedures planned actually performed |
| Tumour response | 12 months | Analysis of effects of electrochemotherapy on tumor using RECIST criteria |
| Quality of life | 12 months | Analysis of quality of life using the Karnovsky performance index |
| Survival | 12 months | Survival analysis through the calculation of overall survival |
| Immunomonitoring | 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 |
Countries
Italy
Outcome results
None listed