Electrochemotherapy for vulvar cancer treatment
Electrochemotherapy for the Treatment of Vulvar Cancer
This study tests if using electrochemotherapy can effectively treat vulvar cancer by helping cancer-fighting drugs work better for patients with local recurrence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT05916690 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of electrochemotherapy as a local treatment for vulvar cancer, aiming to assess its efficacy, feasibility, and safety. The approach involves delivering cytotoxic agents, such as bleomycin or cisplatin, to tumors that have been exposed to electroporation, which enhances drug uptake by cancer cells. The study targets patients with local recurrence of vulvar cancer and evaluates the treatment's effectiveness compared to other local ablation techniques.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a confirmed local recurrence of vulvar cancer and a tumor diameter of 50 millimeters or less.
Not a fit: Patients with life-threatening systemic diseases, regional or distant metastases, or significant coagulation disorders may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a highly effective local therapy option for patients with vulvar cancer.
How similar studies have performed: Other studies have shown promising results with electrochemotherapy for various tumors, indicating potential success for this approach in vulvar cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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
Where this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Maja Cemazar
- Email: mcemazar@onko-i.si
- Phone: +386-1-5879-544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.