2024-512487-61-00Active, not recruitingPhase 3
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).
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Aug 2024
Brief summary (registry, in English)
To evaluate efficacy and safety of irreversible electroporation (IRE), calcium (CaCl2) electroporation and electrochemotherapy (ECT) in patients with pancreatic cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 73 (estimated)
- First submitted
- 2 Jul 2024
- Start date
- 10 Feb 2022
- Lead sponsor
- Wroclaw Medical University
- Diseases
- Pancreatic cancer
- EU CT number
- 2024-512487-61-00
- EudraCT number
- 2021-004987-91
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 73
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Lab values
- INR > 1,5 without use of anticoagulants
Age
- Age under 18 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Poland | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.