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RecruitingNCT05916690Updated Jan 19, 2024

Electrochemotherapy for the Treatment of Vulvar Cancer

An interventional study of Electrochemotherapy with bleomycin or cisplatin in Vulvar Cancer, sponsored by Institute of Oncology Ljubljana. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by Institute of Oncology Ljubljana · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Registered 2 years 3 months after the study started (first participant enrolled Mar 2021, registered Jun 2023).
  • Started Mar 2021; still recruiting 5 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.

02

Conditions studied

  • Vulvar Cancer

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03

In context

Vulvar Neoplasms

210 studies on the registry are indexed under Vulvar Neoplasms; 71 are open to participants now.

This study's planned enrollment of 20 is below the median of 55 across 151 interventional studies indexed under Vulvar Neoplasms.

Browse Vulvar Neoplasms studies →

Lead sponsor

Institute of Oncology Ljubljana is the lead sponsor of 88 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Local recurrence of vulvar cancer confirmed by histology
  2. The longest diameter of tumor 50 millimeters or less
  3. Age more than 18 years
  4. Life expectancy of more than 3 months
  5. Performance status according to Karnofsky ≥ 70 or \< or 2 according to the WHO scale
  6. At least 2 weeks have passed since the last treatment
  7. The patient must be able to understand the treatment process and possible side effects that may occur during the treatment
  8. Signed informed consent form
  9. The patient must be presented at a Multidisciplinary Tumor Board

Exclusion criteria

Exclusion Criteria:

  1. Life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases
  2. Regional or distant metastases
  3. Age less than 18 years
  4. Major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin K or fresh frozen plasma)
  5. Exposure to cumulative bleomycin doses greater than 400 mg
  6. Impaired renal function (Creatinine > 150 µmol/L)
  7. Epilepsy
  8. Pregnancy
  9. Patients who are unable to understand the treatment process or refuse to be involved in the treatment process
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Electrochemotherapy

    Drug: Electrochemotherapy with bleomycin or cisplatin

Interventions

  • DrugElectrochemotherapy with bleomycin or cisplatin

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

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What researchers measure

Primary outcomes

  1. Number of adverse events 1 month after the treatment

    According to CTCAE v5.0

    Time frame: 1 month

  2. Number of adverse events 2 months after the treatment

    According to CTCAE v5.0

    Time frame: 2 months

  3. Number of adverse events 3 months after the treatment

    According to CTCAE v5.0

    Time frame: 3 months

  4. Number of adverse events 6 months after the treatment

    According to CTCAE v5.0

    Time frame: 6 months

  5. Number of adverse events 9 months after the treatment

    According to CTCAE v5.0

    Time frame: 9 months

  6. Number of adverse events 12 months after the treatment

    According to CTCAE v5.0

    Time frame: 12 months

  7. Response of the tumor to electrochemotherapy according to RECIST criteria

    According to RECIST criteria

    Time frame: 1 month

  8. Response of the tumor to electrochemotherapy according to RECIST criteria

    According to RECIST criteria

    Time frame: 2 months

  9. Response of the tumor to electrochemotherapy according to RECIST criteria

    According to RECIST criteria

    Time frame: 3 months

  10. Response of the tumor to electrochemotherapy according to RECIST criteria

    According to RECIST criteria

    Time frame: 6 months

  11. Response of the tumor to electrochemotherapy according to RECIST criteria

    According to RECIST criteria

    Time frame: 9 months

  12. Response of the tumor to electrochemotherapy according to RECIST criteria

    According to RECIST criteria

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Institute of Oncology Ljubljana
    Ljubljana, Slovenia
    • Maja Cemazar · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05916690
Lead sponsor
Institute of Oncology Ljubljana
Responsible party
Sponsor
First posted
Jun 23, 2023
Start date
Mar 1, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 19, 2024

Study contacts

Maja Cemazar
Contact
mcemazar@onko-i.si
+386-1-5879-544

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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