Actively Recruiting
Electrochemotherapy of Gynecological Cancers
Led by Institute of Oncology Ljubljana · Updated on 2024-10-17
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, feasibility, and safety of electrochemotherapy for treating local and regional recurrences of gynecological cancers in patients who have exhausted standard treatment options. This phase 2 interventional study focuses on patients with gynecological tumors that have relapsed locally or regionally where no other treatments remain viable. The study involves electrochemotherapy using bleomycin or cisplatin. Treatment is delivered under anesthesia, and patients must be suitable candidates for this procedure. The trial includes regular follow-up to assess tumor response and safety outcomes over a period of up to 24 months. Participants will undergo evaluations of tumor changes based on RECIST 1.1 criteria and safety monitoring according to CTCAE v5.0 criteria during hospitalization and throughout the 24-month follow-up. Patients will be assessed for life expectancy, performance status, and other health factors before enrollment. The study aims to monitor responses and adverse reactions related to electrochemotherapy treatment in this patient group.
CONDITIONS
Brief Title
Electrochemotherapy of Gynecological Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Local or regional relapse of gynecological tumors where standard treatment options have been exhausted
- Age over 18 years
- Life expectancy greater than 3 months
- Karnofsky performance status of 70 or higher or WHO status less than 2
- Minimum treatment-free interval of 2 weeks
- Mentally capable of understanding treatment information and potential adverse reactions
- Able to give informed consent
- Discussed at a multidisciplinary team before enrollment
- Suitable for anesthesia
You will not qualify if you...
- Presence of visceral, bone, or diffuse metastases
- Life-threatening infection, heart failure, liver failure, or other severe systemic diseases
- Significant reduction in respiratory function
- Age under 18 years
- Coagulation disorders unresponsive to standard treatment
- Cumulative bleomycin dose of 400 mg/m2 or more
- Impaired kidney function (creatinine over 150 �b5mol/l)
- History of epilepsy
- Pregnancy
- Inability to understand the study purpose or refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During hospitalization
Participants receive electrochemotherapy with bleomycin or cisplatin for gynecological cancers.
1 hospitalization visit
Duration - Up to 24 months
Participants are monitored for effectiveness and safety of electrochemotherapy regularly after treatment.
Regular visits for up to 24 months
Trial Site Locations
Total: 1 location
1
Institute of oncology Ljubljna
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
G
Gregor Serša, PhD
M
Maja Čemažar, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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