Patient suffering from exocrine or neuroendocrine, non-metastatic and inoperable pancreatic cancer, stage III MedDRA version: 21.0 Level: LLT Classification code 10033600 Term: Pancreatic adenocarcinoma non-resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: BLEOPRIM - 15 MG POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: BLEOMICINA SOLFATO
CAS Number: 11056-06-7
Current Spons
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety assessment of the impact of ECT associated with bleomycin ;Secondary Objective: 1. feasibility assessment of the applied technique 2. ECT quality life assessment 3. ECT treatment response evaluation 4. Overall Survival assessment at 18 months ;Primary end point(s): 1) monitoring adverse events according to CTCAE criteria during the 18 months of follow up 2) monitoring clinical paramenters (T° C, blood pressure, heart rate), laboratory parameters (specific tumor markers CEA and Ca19.9 and inflammation index PCR) and instrumental parameters (eventually normal clinical practice exams) during the 18 months of follow up;Timepoint(s) of evaluation of this end point: 18 months of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 18 mesi di follow up;Secondary end point(s): 1) feasibility assessment of the applied technique understood as perfectly successful operation (bleomycin injection and proper and possible insertion of electrodes in the time and manner prescribed by the protocol) 2) for the Quality Life assessment it will use the Karnofsky Performance Index 13.12 each follow-up visit (to 1.3.6.9.12.15.18 months after ECT) and VAS to the different time points (to 1.3.6.9.12.15.18 months after ECT) 3) for ECT treatment response evaluation it will used RECIST criteria to 1.3.6.9.12 months after ECT 4) Overall Survival measurement at 12th month after ECT, measured as time from ECT to death because of all causes5) adaptive and innate immune response will be evaluated by the variation in levels of IL6 and HSP70 between the pre-ECT, 2 days and 30 days after surgery. | — |
Countries
Italy
Contacts
Public Contactsupporto no profit
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Outcome results
None listed