Electrochemotherapy of Gynecological Cancers (GynECT)

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecological Cancers
• Intervention / Treatment: Combination product: Electrochemotherapy with bleomycin or cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gregor Serša, PhD; Phone Number: +386 1 5879 434; Email: gsersa@onko-i.si
• Study Contact Backup: Name: Maja Čemažar, PhD; Phone Number: +386 1 5879 544; Email: mcemazar@onko-i.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Institute of oncology Ljubljna
    • Contact: Gregor Sersa, PhD; Phone Number: +386-1-5879-544; Email: gsersa@onko-i.si
    • Contact: Maja Cemazar, PhD; Email: mcemazar@onko-i.si
    • Principal Investigator: Barbara Šegedin, MD, PhD
    • Sub-Investigator: Helena Barbara Zobec Logar, MD, MSc
    • Sub-Investigator: Gregor Sersa, PhD
    • Sub-Investigator: Maja Cemazar, PhD
    • Sub-Investigator: Maša Bošnjak, MPharm, PhD
    • Sub-Investigator: Tjaša Pečnik, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrochemotherapy of gynecological cancers	Combination product: Electrochemotherapy with bleomycin or cisplatin; Electrochemotherapy with cisplatin or bleomycin of gynecological cancers; Other Names: Combination of drug delivery platform (electroporation) and drug (bleomycin or cisplatin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cisplatin; Electrochemotherapy; Bleomycin
• Additional Relevant MeSH Terms: Antineoplastic Agents; Antibiotics, Antineoplastic; Cisplatin; Bleomycin
• Other Study ID Numbers: 0120-692/2017/4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No