Electrochemotherapy of Gynecological Cancers
ConditionGynecological Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-105
SponsorInstitute of Oncology Ljubljana
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Electrochemotherapy with bleomycin or cisplatin
Combination productElectrochemotherapy with cisplatin or bleomycin of gynecological cancers
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Electrochemotherapy of gynecological cancersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Changes from baseline regularly up to 24 monthsSecondary outcomes
1
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.
Time frame
during hospitalization and up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov