Prospective phase IIb study to evaluate the efficacy of laparoscopic electrochemotherapy in the treatment of locally advanced pancreatic cancer - ECT-LAPC Laparoscopic
Key facts
- Where
- Bologna, Genoa, Messina és Naples, OlaszországSee the 5 sites
- Phase
- 2. fázis
Where in Olaszország
- A. O. U. Policlinico Sant'Orsola MalpighiBologna, OlaszországNo longer taking part
- IRCCS Ospedale Policlinico San MartinoGenoa, OlaszországNo longer taking part
- Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessina, OlaszországNo longer taking part
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, OlaszországNo longer taking part
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Trial code
- EU 2024-519067-17-00
- Record updated
- 2024. december 2.
- Original description
The aim of the study is to evaluate the efficacy of electrochemotherapy followed by conventional systemic treatment compared to the only systemic treatment in LAPC in terms of objective response. The use of ECT and IRE, in deep cancer e.g. liver and pancreas, currently requires a laparotomy surgical approach and limits its applicability due to the risks associated with open surgery. In our study a new generation of electrodes suitable to treat tumor nodules with ECT with a minimally invasive approach, i.e. laparoscopic surgery, will be used.Read full original descriptionShow less
The aim of the study is to evaluate the efficacy of electrochemotherapy followed by conventional systemic treatment compared to the only systemic treatment in LAPC in terms of objective response. The use of ECT and IRE, in deep cancer e.g. liver and pancreas, currently requires a laparotomy surgical approach and limits its applicability due to the risks associated with open surgery. In our study a new generation of electrodes suitable to treat tumor nodules with ECT with a minimally invasive approach, i.e. laparoscopic surgery, will be used.
Inclusion: Age≥ 18 years; Good mental health conditions; Ability to sign a specific informed consent in order to be enrolled to the study; Life expectancy in line with the follow-up indicated by the study; Diagnosis of exocrine pancreatic cancer with histological confirmation; Preoperative Staging of locally advanced pancreatic cancer disease: stage III; The subject is not eligible for the "gold-standard" treatment of surgical pancreatectomy and is eligible for a conventional systemic treatment (FOLFOXIRI).
Exclusion: Previous allergic reactions to bleomycin; Previous cumulative dose of 250 mg/m2 of bleomycin exceeded; Absolute contraindication to surgery; Presence of extrahepatic spread of the disease; Any serious and uncontrolled systemic illness; Acute lung infection; Non correctable severe coagulation disorders; Age less than 18 years; Contraindications at the assumption of bleomycin (Bleoprim); Pregnancy or lactation; Visceral, bone or diffuse metastases; Clinically significant ascites; Symptoms of poor lung function by clinical examination and Pulmonary function tests (PFT).