Clinical trial · Interventional
ECT STUDY High-grade or Initially Invasive Vulva - GinOnc-ECT Study
Monocentric Phase II Study on the Use of Electrochemotherapy in the Treatment of Paget's Disease and High-grade Squamous Precancerous Lesions or Initially Invasive Vulvar Lesions (GinOnc-ECT Study).
NCT06715592CI-TRIAL-00093326active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with a new diagnosis or recurrence of high-grade squamous precancerous lesions or initially non-invasive vulvar Paget's disease, who have not undergone other types of treatment, will be considered at the Fondazione Policlinico Universitario A. Gemelli - IRCCS - in Rome.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Paget Disease of the Vulva | Vulvar Paget Disease | ALIAS | 0.90 |
| Vulva Cancer | Vulvar Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomicina | Drug | Bleomycin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ECT Electrochemotherapy
- description
- The ways in which ECT treatment will be applied have been codified at European level from the 2006 ESOPE study
- interventionNames
- Drug: Bleomicina
Primary outcomes (1)
- measure
- Evaluation of the activity of electrochemotherapy in the treatment of vulvar lesions and noninvasive M. of Paget
- timeFrame
- 30 days post treatment and then Outpatient visit at 3, 6 and 12 months from procedures.
- description
- Evaluation of treatment response will be done by histological analysis of surgical specimens after lesion excision at 30 days after ECT.Thereafter, patients will be evaluated by the gynecologic oncologist in the outpatient clinic at 3,6 and 12 months after the procedure.Inspection of the genitals and pelvic region will be performed during the follow-ups,and if necessary,new biopsies of the previously treated area will be taken.Criteria for response to ECT will be defined as:complete response(CR)when there is disappearance of the pre-tumor/tumor lesion;partial response(PR )if the lesion appears reduced by more than 30% in the product between the two major perpendicular diameters; stable disease(NC=no change)when the lesion is reduced by less than 30% or increased by less than 20% of its volume;disease progression(PD)if there is a lesion size increase of at least 20%.In cases where it is not objectively possible to measure tumor size,the response will be recorded as "not evaluable"(NV).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of de novo or recurrent vulvar VIN 2-3, microinvasive vulvar carcinoma in situ, and non-invasive vulvar Paget's disease * Positivity for high-risk cervical and/or vaginal HPV * Age \> 18 years * Karnofsky performance status \>70% * Informed consent to participate in the study * No surgical treatment indication due to disease extension, patient refusal, anesthesiological or reconstructive reasons * Negative Beta-hCG measurement in urine (pregnancy test or urinary beta-HCG) or in blood (plasma beta-HCG) Exclusion Criteria: * Patients with a histological diagnosis of adenocarcinoma * Patients with concomitant and/or previous tumors * Current pregnancy and breastfeeding * Chronic renal insufficiency * Chronic renal dysfunction * Patients with a cardiac pacemaker * Epilepsy * Lung diseases with moderate/severe respiratory insufficiency * Poor lung function or abnormal lung function * Significant coagulation disorders * Coagulation abnormalities (platelets \< 70,000/mm³ and INR \> 1.5) * Ongoing HPV vaccination * Patients with immunosuppressive conditions or treatments (HIV positive) * Allergy to Bleomycin and/or Cisplatin * Cumulative doses of 250 mg/m² of Bleomycin received
References
Publications (0)
Data not yet available
No reference posted for this study.