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STUDY ON SAFETY AND FEASIBILITY OF ELECTROCHEMOTHERAPY USED IN OPERATORY ROOM FOR A PATIENT WITH CANCER PANCREAS NOT OPERABLE

Phase 1
Conditions
Patient suffering from exocrine or neuroendocrine, non-metastatic and inoperable pancreatic cancer, stage III
MedDRA version: 21.0Level: LLTClassification code 10033600Term: Pancreatic adenocarcinoma non-resectableSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Registration Number
EUCTR2015-002077-37-IT
Lead Sponsor
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
20
Inclusion Criteria

1. Female and Male, Ege =18 =80 anni. Women will' perform pregnacy test before surgery and during follow up visit.
2. Consent form signed
3. Patient that could done follow up (18 months)
4. Diagnosis of pancreatic cancer, confirmed by histological test.
5. Stage III
6. Patient colud not be trated with gold-standard” (surgery)
7. Stable Disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1. Age =18 =80
2. pregnant
3. Patient that not accepted to use contraceptive methods
4. Patient that coul not done surgery
5. Patient with disease not stable
6. Patient with liver , lung and /or peritoneal.
7. Patient that take phenytoin , fosphenytoin , live vaccines

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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