Bleomicina: Colposcopically guided ECT following intralesional administration / intravenous Bleomycin or intralesional Cisplatin according to ESOPE recommendations. Reassessment after 30 days by colposcopy and conization with acquisition of histological examination.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Evaluation of the activity of electrochemotherapy in the treatment of vulvar lesions and noninvasive M. of Paget — 30 days post treatment and then Outpatient visit at 3, 6 and 12 months from procedures. 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).
Trial sites (1)
Facility
City
Region
Status
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome
Lazio
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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