ECT STUDY High-grade or Initially Invasive Vulva - GinOnc-ECT Study

NCT06715592 | Active Not Recruiting Phase 2

• 1 other identifier: GinOnc-ECT study
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Paget Disease of the Vulva; Vulva Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of the activity of electrochemotherapy in the treatment of vulvar lesions and noninvasive M. of Paget

  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).

  30 days post treatment and then Outpatient visit at 3, 6 and 12 months from procedures.

Study Arms (1)

ECT Electrochemotherapy

EXPERIMENTAL

The ways in which ECT treatment will be applied have been codified at European level from the 2006 ESOPE study

Drug: Bleomicina

Interventions

Bleomicina DRUG

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.

Also known as: CISPLATIN

ECT Electrochemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Bleomycin; Cisplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Giacomo Corrado

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 4, 2024
• Study Start: May 23, 2023
• Primary Completion: March 31, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

IT (1)