Electrochemotherapy of Gynecological Cancers

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    30
  • sponsor
    Institute of Oncology Ljubljana
Updated on 26 February 2021

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.

Details
Condition Uterine Cancer, Brenner Tumor, UTERINE FIBROID, Uterine Fibroids, Leiomyomas
Treatment Electrochemotherapy with bleomycin or cisplatin
Clinical Study IdentifierNCT04760327
SponsorInstitute of Oncology Ljubljana
Last Modified on26 February 2021

Eligibility

Yes No Not Sure

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 mol/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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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