Electrochemotherapy of Gynecological Cancers (GynECT)

Institute of Oncology Ljubljana

Status and phase: Enrolling; Phase 2

Conditions: Gynecological Cancers

Treatments: Combination Product: Electrochemotherapy with bleomycin or cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04760327

0120-692/2017/4

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 105 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Electrochemotherapy of gynecological cancers

Experimental group

Treatment:

Combination Product: Electrochemotherapy with bleomycin or cisplatin