Electrochemotherapy of Gynecological Cancers

Gynecological Cancers Clinical Trial

— GynECT  

Official title:

Electrochemotherapy of Gynecological Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04760327
• Other study ID #: 0120-692/2017/4
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2021
• Source: Institute of Oncology Ljubljana
• Contact: Gregor Serša, PhD
• Phone: +386 1 5879 434
• Email: gsersa[@]onko-i.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 105 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gynecological Cancers

Intervention

Combination Product:
• Electrochemotherapy with bleomycin or cisplatin
Electrochemotherapy with cisplatin or bleomycin of gynecological cancers

Locations

Country	Name	City	State
Slovenia	Institute of oncology Ljubljna	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Oncology Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of electrochemotherapy according to RECIST 1.1 criteria.	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.	Changes from baseline regularly up to 24 months
Secondary	Safety of electrochemotherapy according to CTCAE v5.0 criteria.	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.	during hospitalization and up to 24 months