Electrochemotherapy of Gynecological Cancers

Phase 2

Recruiting

• Conditions: Gynecological Cancers
• Interventions: Combination Product: Electrochemotherapy with bleomycin or cisplatin

• Registration Number: NCT04760327
• Lead Sponsor: Institute of Oncology Ljubljana

Brief Summary

To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and/or regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-05
• Study Start: 2020-07-01
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrochemotherapy of gynecological cancers	Electrochemotherapy with bleomycin or cisplatin	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of electrochemotherapy according to RECIST 1.1 criteria.	Changes from baseline regularly up to 24 months	Effectiveness of electrochemotherapy in the treatment of local or regional recurrences of gynecological tumors in which standard treatment options have been exhausted. Effectiveness will be evaluated according to RECIST 1.1 criteria.

Secondary Outcome Measures

Name	Time	Method
Safety of electrochemotherapy according to CTCAE v5.0 criteria.	during hospitalization and up to 24 months	To determine safety of electrochemotherapy in the treatment of local or regional recurrences of gynecological tumors in which standard treatment options have been exhausted. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 criteria will be determined.

Trial Locations

Locations (1)

Institute of oncology Ljubljna; 🇸🇮 Ljubljana, Slovenia