locally advanced pancreatic carcinoma
Conditions
Interventions
Trade Name: Bleoprim
Product Name: Bleoprim - Bleomicina
Pharmaceutical Form: Powder and solution for solution for injection
Trade Name: Fluorouracile Teva
Product Name: Fluorouracile
Pharmaceutical
Sponsors
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Age> 18 years b) Good mental health conditions c) Ability to sign a specific informed consent in order to be admitted to the study. d) Life expectancy in line with the follow-up indicated by the study e) Diagnosis of exocrine pancreatic cancer with histological confirmation f) Preoperative Staging of locally advanced pancreatic cancer disease: stage III g) The subject is not eligible for the "gold-standard" treatment of surgical pancreasectomy and is eligible for a conventional systemic treatment (FOLFOXIRI) 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 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: a) Age less than 18 years b) Absolute contraindication to surgery c) Visceral, bone or diffuse metastases d) Presence of extrahepatic spread of the disease e) Infection and / or heart failure and / or hepatic failure and / or other serious systemic diseases f) Clinically significant ascites g) Any serious and uncontrolled systemic illness h) Acute pulmonary infection i) Symptoms of poor lung function j) Severe coagulation disorders that can not be corrected k) Previous allergic reactions to bleomycin l) The cumulative dose of bleomycin of 250 mg / m2 was exceeded m) Chronic renal dysfunction (creatinine> 150 µmol / L should be considered a lower administered dose of bleomycin) n) Pregnancy or breastfeeding ** ** Pregnancy has been established prior to enrollment by beta-HCG assay on urine (pregnancy test or urinary beta-HCG) or blood (plasma beta-HCG).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Increase of the objective response rate of the lesion treated in the treatment arm compared to the control arm;Secondary Objective: a) Evaluate the effect of ECT on disease progression free time and survival. b) Evaluate the impact of ECT on quality of life with particular attention to the effect on pain. c) Evaluating the toxicity associated with the treatment of Electrochemotherapy.;Primary end point(s): Evaluation of the objective response;Timepoint(s) of evaluation of this end point: The objective response at 1, 3 and 6 months from ECT will be based on the CT / MR / PET-CT response performed by the radiologist using morphological criteria (RECIST 1.1), densitometrics (mRECIST and CHOI criteria) and functional parameters extracted from the post processing of MRI data and the PERCIST criteria of PET / CT. The long-term objective response of the treatment (9 and 12 months from the procedure) will be evaluated with the mRECIST criteria, which will take into account the difference in size and density, determined by the images obtained by CT perforation of the tumor nodules treated before and after ECT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Evaluate the effect of ECT on disease progression free time and survival. 2) Evaluate the impact of ECT on quality of life with particular attention to the effect on pain. 3) To evaluate the toxicity associated with the treatment of Electrochemotherapy.;Timepoint(s) of evaluation of this end point: 137/5000 Evaluation of secondary endpoints will be performed at follow-up visits: 0, 3, 15, 30, 90, 180, 270 and 360 days from treatment | — |
Countries
Italy
Contacts
Public ContactSC Chi Oncologica Epato-Biliare
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Outcome results
None listed