Recruiting NCT04760327
Electrochemotherapy of Gynecological Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrochemotherapy with bleomycin or cisplatin.
- Who it may be relevant to
- Registry conditions: Gynecological Cancers. Basic parameters: 18 years — 105 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Combination product Electrochemotherapy with bleomycin or cisplatin
Electrochemotherapy with cisplatin or bleomycin of gynecological cancers
Primary outcome measures
- Effectiveness of electrochemotherapy according to RECIST 1.1 criteria. [Time frame: Changes from baseline regularly up to 24 months]
Secondary outcome measures (1)
- Safety of electrochemotherapy according to CTCAE v5.0 criteria. [Time frame: during hospitalization and up to 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- Institute of oncology Ljubljna — Ljubljana
Identifiers
NCT: NCT04760327 · 0120-692/2017/4