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GynECT: Electrochemotherapy of Gynecological Cancers

Sponsor
Institute of Oncology Ljubljana (Other)
Overall Status
Recruiting
CT.gov ID
NCT04760327
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
66
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Electrochemotherapy with bleomycin or cisplatin
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Electrochemotherapy of Gynecological Cancers
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Electrochemotherapy of gynecological cancers

Combination Product: Electrochemotherapy with bleomycin or cisplatin
Electrochemotherapy with cisplatin or bleomycin of gynecological cancers
Other Names:
  • Combination of drug delivery platform (electroporation) and drug (bleomycin or cisplatin)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 105 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of oncology Ljubljna Ljubljana Slovenia 1000

    Sponsors and Collaborators

    • Institute of Oncology Ljubljana

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institute of Oncology Ljubljana
    ClinicalTrials.gov Identifier:
    NCT04760327
    Other Study ID Numbers:
    • 0120-692/2017/4
    First Posted:
    Feb 18, 2021
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institute of Oncology Ljubljana
    Electrochemotherapy
    Cisplatin
    Bleomycin
    Additional relevant MeSH terms:
    Cisplatin
    Bleomycin

    Study Results

    No Results Posted as of Feb 18, 2021