Treatment of gynecological cancers using electrochemotherapy

Electrochemotherapy of Gynecological Cancers

This study is testing if electrochemotherapy can help adults with recurring gynecological cancers feel better after other treatments have not worked.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 105 Years
• Sex: Female
• Sponsor: Institute of Oncology Ljubljana (Academic / other)
• Locations: 1 site (Ljubljana)
• Trial ID: NCT04760327 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness, feasibility, and safety of electrochemotherapy for patients with local or regional recurrences of gynecological cancers after standard treatment options have been exhausted. The intervention involves administering electrochemotherapy using either bleomycin or cisplatin. Patients will be monitored for their response to treatment and any adverse effects that may arise. The study is designed for individuals over 18 years old with a Karnofsky performance status of 70 or higher.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with local or regional relapses of gynecological tumors who have exhausted standard treatment options.

Not a fit: Patients with visceral, bone, or diffuse metastases, or those with severe systemic pathologies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with limited alternatives for managing their gynecological cancers.

How similar studies have performed: Other studies have shown promise with electrochemotherapy in various cancer types, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted.
2. Age more than 18.
3. Life expectancy more than 3 month.
4. Performance status Karnofsky ≥ 70 or WHO \< or 2.
5. Treatment free interval minimum 2 weeks.
6. Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment.
7. Patient must give informed consent.
8. Patient must be discussed at the multidisciplinary team before entering the trial.
9. Patient should be suitable for anesthesia.

Exclusion Criteria:

1. Visceral, bone or diffuse metastases.
2. Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
3. Significant reduction in respiratory function.
4. Age less than 18 years.
5. Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).
6. Cumulative dose of ≥ 400 mg/m2 bleomycin received.
7. Impaired kidney function (creatinin \> 150 µmol/l).
8. Patients with epilepsy.
9. Pregnancy.
10. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.

Where this trial is running

Ljubljana

• Institute of oncology Ljubljna — Ljubljana, Slovenia (Recruiting)

Study contacts

• Study coordinator: Gregor Serša, PhD

Conditions Gynecological Cancers; Electrochemotherapy; Cisplatin; Bleomycin