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NCT Number: NCT04760327

Electrochemotherapy of Gynecological Cancers

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.

Recruiting

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Key information

Age range

18 year–105 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Institute of oncology Ljubljna

Ljubljana, 1000, Slovenia

Location status: Recruiting

Location contact

Barbara Šegedin, MD, PhD

PRINCIPAL_INVESTIGATOR

Gregor Sersa, PhD

CONTACT

[email protected]

+386-1-5879-544

Gregor Serša, PhD

SUB_INVESTIGATOR

Helena Barbara Zobec Logar, MD, MSc

SUB_INVESTIGATOR

Maja Cemazar, PhD

CONTACT

[email protected]

Maja Čemažar, PhD

SUB_INVESTIGATOR

Manja Šešek, MD

SUB_INVESTIGATOR

Maša Bošnjak, MPharm, PhD

SUB_INVESTIGATOR

Tjaša Pečnik, BSc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Electrochemotherapy with bleomycin or cisplatin

Combination Product

Electrochemotherapy with cisplatin or bleomycin of gynecological cancers

Other names: Combination of drug delivery platform (electroporation) and drug (bleomycin or cisplatin)

Primary outcomes

  1. Effectiveness of electrochemotherapy according to RECIST 1.1 criteria.

    Time frame: 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 outcomes

  1. Safety of electrochemotherapy according to CTCAE v5.0 criteria.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregor Serša, PhD

CONTACT

[email protected]

+386 1 5879 434

Maja Čemažar, PhD

CONTACT

[email protected]

+386 1 5879 544

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Acronym: GynECT

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2021
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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