BridgeMD
New treatment option for Vulvar Cancer
Official title Electrochemotherapy for Recurrent Vulvar Cancer
ClinicalTrials.gov ID: NCT07443475
What this study is testing
- What it's testing
- This phase I/II interventional study evaluates the effectiveness and safety of electrochemotherapy (ECT) as neoadjuvant treatment for local recurrence of vulvar cancer. Electrochemotherapy combines intravenous administration of bleomycin with delivery of electric pulses to the tumor area, increasing drug uptake into cancer cells.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Local recurrence of vulvar cancer
- Age ≥ 18 years
- Expected life expectancy \> 3 months
- Karnofsky performance status ≥ 70 or WHO performance status ≤ 2
- At least 2 weeks since last treatment
You likely can't join if
- Life-threatening infection and/or severe cardiac, hepatic, or other systemic disease
- Significantly reduced lung function requiring DLCO testing (patients with abnormal DLCO are excluded)
- Age \< 18 years
- Major coagulation disorders not responding to standard therapy
- Prior cumulative bleomycin dose ≥ 400 mg/m²
- Chronic renal impairment (creatinine \> 150 µmol/L)
See the full eligibility criteria
- Local recurrence of vulvar cancer
- Age ≥ 18 years
- Expected life expectancy \> 3 months
- Karnofsky performance status ≥ 70 or WHO performance status ≤ 2
- At least 2 weeks since last treatment
- Ability to understand the procedure and possible adverse effects
- Ability to provide written informed consent
- Patient discussed at multidisciplinary tumor board before enrollment
- Fit for anesthesia
- Life-threatening infection and/or severe cardiac, hepatic, or other systemic disease
- Significantly reduced lung function requiring DLCO testing (patients with abnormal DLCO are excluded)
- Age \< 18 years
- Major coagulation disorders not responding to standard therapy
- Prior cumulative bleomycin dose ≥ 400 mg/m²
- Chronic renal impairment (creatinine \> 150 µmol/L)
- Epilepsy
- Pregnancy
- Inability to understand the study or refusal to participate
The study team makes the final eligibility decision.
Where it's taking place
- Ljubljana, Slovenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ljubljana, Slovenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.