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RecruitingPhase 2NCT04760327

Electrochemotherapy of Gynecological Cancers

Sponsor

Institute of Oncology Ljubljana

Enrollment

30 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

Gynecological Cancers

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 105 Years

Inclusion Criteria9

  • 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 Criteria10

  • 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.
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Interventions

COMBINATION_PRODUCTElectrochemotherapy with bleomycin or cisplatin

Electrochemotherapy with cisplatin or bleomycin of gynecological cancers

Locations(1)

Institute of oncology Ljubljna

Ljubljana, Slovenia

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NCT04760327

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