Gynecological Cancers
Conditions
Keywords
Electrochemotherapy, Cisplatin, Bleomycin
Brief 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.
Interventions
COMBINATION_PRODUCTElectrochemotherapy with bleomycin or cisplatin
Electrochemotherapy with cisplatin or bleomycin of gynecological cancers
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 105 Years
Healthy volunteers
No
Inclusion criteria
1. Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted. 2. Age more than 18. 3. Life expectancy more than 3 month. 4. Performance status Karnofsky ≥ 70 or WHO \< or 2. 5. Treatment free interval minimum 2 weeks. 6. Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment. 7. Patient must give informed consent. 8. Patient must be discussed at the multidisciplinary team before entering the trial. 9. Patient should be suitable for anesthesia.
Exclusion criteria
1. Visceral, bone or diffuse metastases. 2. Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies. 3. Significant reduction in respiratory function. 4. Age less than 18 years. 5. Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma). 6. Cumulative dose of ≥ 400 mg/m2 bleomycin received. 7. Impaired kidney function (creatinin \> 150 µmol/l). 8. Patients with epilepsy. 9. Pregnancy. 10. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of electrochemotherapy according to RECIST 1.1 criteria. | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety of electrochemotherapy according to CTCAE v5.0 criteria. | 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. |
Countries
Slovenia
Contacts
Primary ContactGregor Serša, PhD
Backup ContactMaja Čemažar, PhD
Outcome results
None listed