Clinical trial · Interventional
Electrochemotherapy of Gynecological Cancers
NCT04760327CI-TRIAL-00081680GynECTrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecological Cancers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrochemotherapy with bleomycin or cisplatin | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Electrochemotherapy of gynecological cancers
- interventionNames
- Combination Product: Electrochemotherapy with bleomycin or cisplatin
Primary outcomes (1)
- measure
- Effectiveness of electrochemotherapy according to RECIST 1.1 criteria.
- timeFrame
- Changes from baseline regularly up to 24 months
- description
- 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 outcomes (1)
- measure
- Safety of electrochemotherapy according to CTCAE v5.0 criteria.
- timeFrame
- during hospitalization and up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 105 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.