Overview
Sponsor-declared trial summary
patients with newly diagnosed or recurrent high-grade or initially invasive precancerous squamous lesions of the vulva and non-invasive vulvar Paget's disease
Evaluation of the activity of electrochemotherapy in the treatment of vulvar lesions and non-invasive Paget's disease
Key facts
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Jun 2023 → ongoing
- Decision date (initial)
- 2024-11-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518796-65-00
- EudraCT number
- 2023-000128-12
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Evaluation of the activity of electrochemotherapy in the treatment of vulvar lesions and non-invasive Paget's disease
Secondary objectives 4
- Evaluation of the safety of electrochemotherapy
- Evaluation of the control of the presence of HPV
- Follow-up evaluation of vulvar VIN 2-3 and non-invasive Paget's disease
- Evaluation of the symptoms reported by the patient
Conditions and MedDRA coding
patients with newly diagnosed or recurrent high-grade or initially invasive precancerous squamous lesions of the vulva and non-invasive vulvar Paget's disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Histological diagnosis of de novo or recurrent squamous disease of vulvar VIN 2-3, microinvasive carcinoma in situ of the vulva, and noninvasive vulvar Paget's disease
- Positivity for cervical and/or vaginal HR HPV
- Age > 18 years
- Karnofsky performance status >70%
- Informed consent to participate in the study
- Absence of indication for surgical treatment due to extension of the disease, due to patient refusal, for anaesthesiological or reconstructive reasons
- Negative Beta-hCG levels in urine (Pregnancy test or urinary beta-HCG) or blood (plasma beta-hCG)
Exclusion criteria 15
- Patients with histological diagnosis of adenocarcinoma
- Patients with concomitant and/or previous tumours
- Pregnancy in progress and breast feeding
- Chronic renal failure
- Chronic renal dysfunction
- Patients with cardiac pacemakers
- Epilepsy
- Pulmonary pathologies with medium/severe respiratory insufficiency
- Poor or abnormal lung function
- Significant coagulation disorders
- Coagulation disorders (platelets < 70,000/mm3 and INR>1.5)
- HPV vaccination in progress
- Patients with immunosuppressive diseases or treatments (HIV positive)
- Bleomycin and/or Cisplatin allergy
- Cumulative doses of 250mg/sqm of Bleomycin received
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Evaluation of histological pathological response of vulvar lesions and non-invasive Paget's disease on surgical specimens 30 days after electrochemotherapy according to RECIST criteria
Secondary endpoints 4
- Safety of the method evaluated using the CTCAE criteria v. 5.0
- Assessment of HPV persistence by HPV test at the 6-month visit
- Duration of disease control in follow-up
- Symptomatology assessment using specific questionnaires (VAS, EQ-5D, FSFI) filled in by patients before treatment and one, three, six and twelve months after treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB00842MIG · Substance
- Active substance
- Bleomycin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 15 mg/m2 milligram(s)/sq. meter
- Max total dose
- 15 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRATUMORAL USE
- Max daily dose
- 2 mg/ml milligram(s)/millilitre
- Max total dose
- 2 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor organisation
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Address
- Largo Francesco Vito 1
- City
- Rome
- Postcode
- 00168
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Contact name
- Giacomo Corrado
Public contact point
- Organisation
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Contact name
- Giacomo Corrado
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2023-06-17 | 2023-06-17 | 2025-02-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT Number 2024-518796-65-00 | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Consenso trattamento dati | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bleomicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cisplatino | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT_EU CT Number 2024-518796-65-00 | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-08 | Italy | Acceptable 2024-10-29
|
2024-11-25 |