E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
locally advanced pancreatic carcinoma |
carcinoma del pancreas localmente avanzato |
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E.1.1.1 | Medical condition in easily understood language |
carcinoma of the unresectable pancreas |
carcinoma del pancreas non resecabile |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Increase of the objective response rate of the lesion treated in the treatment arm compared to the control arm |
Incremento del tasso di risposta oggettiva della lesione trattata nel braccio di trattamento rispetto al braccio di controllo |
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E.2.2 | Secondary objectives of the trial |
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. |
a) Valutare l'effetto della ECT sul disease progression free time e survival. b) Valutare l'impatto della ECT sulla qualità di vita con particolare attenzione all'effetto sul dolore. c) Valutare la tossicità associata al trattamento di Elettrochemioterapia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
a) Età > 18 anni b) Condizioni di salute mentali buone c) Capacità di firmare un consenso informato specifico al fine di essere ammesso allo studio. d) Aspettativa di vita in linea con il follow-up indicato dallo studio e) Diagnosi di cancro pancreatico esocrino con conferma istologica f) Staging Pre-operativo della malattia di cancro pancreatico localmente avanzato: stage III g) Il soggetto non è eleggibile per il trattamento "gold-standard" di pancreasectomia chirurgica ed è candidabile a trattamento sistemico convenzionale (FOLFOXIRI)
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E.4 | Principal 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). |
a) Età inferiore ai 18 anni b) Controindicazione assoluta alla chirurgia c) Metastasi viscerali, ossee o diffuse d) Presenza di diffusione extraepatica della malattia e) Infezione e/o insufficienza cardiaca e/o insufficienza epatica e/o altre gravi patologie sistemiche f) Ascite clinicamente significativa g) Qualsiasi malattia sistemica grave e incontrollata h) Infezione polmonare acuta i) Sintomi di scarsa funzionalità polmonare j) Gravi disturbi della coagulazione non correggibili k) Precedenti reazioni allergiche alla bleomicina l) È stata superata la dose cumulativa di bleomicina di 250 mg/m2 m) Disfunzione renale cronica (creatinina>150 μmol/L deve essere considerata una dose somministrata più bassa di bleomicina) n) Gravidanza o allattamento**
**Lo stato di gravidanza è stato accertato prima dall’arruolamento mediante il dosaggio della Beta-HCG sulle urine (Test di gravidanza o beta-HCG urinaria) o sul sangue (beta-HCG plasmatica).
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of the objective response |
Valutazione della risposta oggettiva |
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E.5.1.1 | 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. |
La risposta oggettiva a 1, 3 e 6 mesi dalla ECT sarà basata sul responso TC/RM/PET-TC effettuato dal radiologo mediante criteri morfologici (RECIST 1.1), densitometrici (criteri mRECIST e CHOI) e mediante parametri funzionali estratti dal post processing dei dati di RM e dai criteri PERCIST della PET/TC. La risposta oggettiva a lungo termine del trattamento (9 e 12 mesi dalla procedura) sarà valutata con i criteri mRECIST, che prenderanno in considerazione la differenza di dimensione e densità, determinata dalle immagini ottenute dalla perfusione TC dei noduli tumorali trattati prima e dopo ECT. |
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E.5.2 | 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. |
1) Valutare l'effetto della ECT sul disease progression free time e survival. 2) Valutare l'impatto della ECT sulla qualità di vita con particolare attenzione all'effetto sul dolore. 3) Valutare la tossicità associata al trattamento di Elettrochemioterapia.
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E.5.2.1 | 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 |
Sarà effettuata la valutazione degli endpoint secondari alle visite di follow-up: 0, 3, 15, 30, 90, 180, 270 e 360 giorni dal trattamento |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
gruppo di controllo terapia sistema FOLFOXIRI |
45/5000 FOLFOXIRI system therapy control group |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Duration of the study: 72 months 2. Time for enlistment: 60 months 3. Minimum follow-up: 12 months |
Durata dello studio: 72 mesi 2. Tempo per l’arruolamento: 60 mesi 3. Follow-up minimo: 12 mesi
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |