Electrochemotherapy of Gynecological Cancers

NCT ID: NCT04760327

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecological Cancers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electrochemotherapy of gynecological cancers

Group Type EXPERIMENTAL

Electrochemotherapy with bleomycin or cisplatin

Intervention Type COMBINATION_PRODUCT

Electrochemotherapy with cisplatin or bleomycin of gynecological cancers

Interventions

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Electrochemotherapy with bleomycin or cisplatin

Electrochemotherapy with cisplatin or bleomycin of gynecological cancers

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Combination of drug delivery platform (electroporation) and drug (bleomycin or cisplatin)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

105 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institute of Oncology Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of oncology Ljubljna

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Gregor Serša, PhD

Role: CONTACT

+386 1 5879 434

Maja Čemažar, PhD

Role: CONTACT

+386 1 5879 544

Facility Contacts

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Gregor Sersa, PhD

Role: primary

+386-1-5879-544

Maja Cemazar, PhD

Role: backup

Other Identifiers

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0120-692/2017/4

Identifier Type: -

Identifier Source: org_study_id

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