Effects of calcium electroporation, electrochemotherapy, and irreversible electroporation (IRE-CaCl2, ECT and IRE) on quality of life and progression – free survival in patients with pancreatic cancer" (IREC).
Key facts
- Where
- Wroclaw, LengyelországSee the site
- Phase
- 3. fázis
Where in Lengyelország
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclaw, LengyelországNo 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
- Wroclaw Medical University
- Trial code
- EU 2024-512487-61-00
- Record updated
- 2024. augusztus 9.
- Original description
To evaluate efficacy and safety of irreversible electroporation (IRE), calcium (CaCl2) electroporation and electrochemotherapy (ECT) in patients with pancreatic cancer.Read full original descriptionShow less
To evaluate efficacy and safety of irreversible electroporation (IRE), calcium (CaCl2) electroporation and electrochemotherapy (ECT) in patients with pancreatic cancer.
Inclusion: Age over 18 years (male and female); Written informed consent; Histopathological confirmed adenocarcinoma of the pancreas (intraoperative examination possible); Lesion defined as unresectable (infiltration of mesenteric or portal vein exceeding 180 degrees or its thrombosis, infiltration of the hepatic artery, celiac artery or superior mesenteric artery) on abdominal CT/MRI not older than 60 days (stage III), or patients after resection with local recurrence of the neoplastic process; Tumor size not larger than 6 cm on a CT/MRI scan not older than 60 days; Patients undergoing chemotherapy or patients with a "de novo" diagnosis of pancreatic cancer; ECOG performance status: 0,1 or 2.
Exclusion: Body temperature >38°C or any infection requiring antibiotic therapy within 24 hours prior to study treatment. 12. Overuse or addiction to alcohol, drugs or any other substances (caffeine and nicotine excluded); Significant cardiac abnormality (rhythm other than sinus rhythm); Allergy to contrast media that would compromise the ability to perform imaging after surgery; Documented history of allergy to bleomycin; Documented history of pulmonary fibrosis; Patient with metastatic stage IV disease; INR > 1,5 without use of anticoagulants; Age under 18 years; Any circumstances, that in the Investigator's judgement may prevent the patient from participating in the study, undergoing the study assessments in accordance with the protocol or bear unjustified risk to the patient; Inability to give consent in writing; Pregnant or lactating women; Patients with pacemakers or any implanted stimulation device.