Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
96
Countries
1
Sites
15
CARCINOMA OF THE ORAL CAVITY AND OROPHARYNX
Superiority of the treatment of Electrochemotherapy with Bleomycin in terms of objective response compared to the treatment with cetuximab + platinum-based therapy + 5-fluorouracil
Key facts
- Sponsor
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 2 Sep 2025
- Decision date (initial)
- 2025-01-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520735-16-00
- EudraCT number
- 2018-003589-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
Superiority of the treatment of Electrochemotherapy with Bleomycin in terms of objective response compared to the treatment with cetuximab + platinum-based therapy + 5-fluorouracil
Secondary objectives 5
- 1. Overall survival
- 2. Assessment of disease-free progression time between the two groups
- 3. Assessment of the duration of the response intended as the time from the first complete or partial response documentation to the first occurrence of disease or death progression
- 4. Assessment of disease control, intended as complete response, partial response and stable disease, between the two groups
- 5. Quality of life assessment (EORTC QLQ-C30, EORTC QLQ-H & N35, EQ-5D-5L) with particular attention to the effect on pain and bleeding between the two groups
Conditions and MedDRA coding
CARCINOMA OF THE ORAL CAVITY AND OROPHARYNX
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061325 | Oral neoplasm | 100000004864 |
| 20.0 | PT | 10031096 | Oropharyngeal cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 1. Age> 18 years;
- 2. Progressive disease (relapse on T and N0) in the oral cavity and oropharynx
- 3. Histological confirmation of head and neck squamous cell carcinoma
- 4. Measurable lesions suitable for applying electrical impulses
- 5. Performance status (Karnofsky = 70; WHO = 2)
- 6. Life expectancy> 3 months
- 7. Patients able to understand the type of treatment they will receive and able to sign informed consent
- 8. Patients who refuse other treatments
Exclusion criteria 12
- 1. Age<18 years;
- 2. Other symptomatic lesions not under control;
- 3. Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.);
- 4. Injectable lesions for systemic treatment with cetuximab + platinum + 5-fluorouracil therapy
- 5. Acute lung infection;
- 6. Symptoms of poor lung function;
- 7. Non correctable severe coagulation disorders;
- 8. Previous allergic reactions to bleomycin;
- 9. Previous cumulative dose of 250 mg/m2 of bleomycin exceeded;
- 10. Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin)
- 11. Any severe and uncontrolled systemic illness
- 12. Pregnancy or lactation **; ** Pregnancy has been established before enrollment by beta-hCG on urine (pregnancy test or urinary beta-HCG) or on blood (plasma beta-hCG)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Superiority of electrochemotherapy treatment with bleomycin in terms of objective response compared to treatment with cetuximab + platinum-based therapy + 5-fluorouracil.
Secondary endpoints 5
- Overall survival
- Assessment of disease-free progression time between the two groups
- Evaluation of the duration of the response intended as the time from the first complete or partial response documentation to the first occurrence of disease or death progression
- Assessment of disease control,intended as complete response, partial response and stable disease, between the two groups
- Quality of life assessment (EORTC QLQ-C30, EORTC QLQ-H & N35, EQ-5D-5L) with particular attention to the effect on pain and bleeding between the two groups
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
BLEOPRIM 15 mg polvere per soluzione iniettabile
PRD431183 · Product
- Active substance
- Bleomycin Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 15000 IU/mg international unit(s)/milligram
- Max total dose
- 15000 IU/mg international unit(s)/milligram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DC01 — BLEOMYCIN
- Marketing authorisation
- 022395026
- MA holder
- SANOFI S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracile Teva 250 mg/5 ml soluzione per infusione
PRD675529 · Product
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 026542062
- MA holder
- TEVA ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP185672 · ATC
- Active substance
- Cetuximab
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC06 — CETUXIMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatino Teva Italia 0,5 mg/ml concentrato per soluzione per infusione
PRD667737 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 100 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 039054034
- MA holder
- TEVA ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CARBOPLATINO TEVA 10 mg/ml concentrato per soluzione per infusione
PRD667179 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/ml milligram(s)/millilitre
- Max total dose
- 5 mg/l milligram(s)/litre
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 034347031
- MA holder
- TEVA PHARMA B.V.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6094344 · ATC
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC18 — PEMBROLIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Sponsor organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Address
- Via Mariano Semmola 52
- City
- Naples
- Postcode
- 80131
- Country
- Italy
Scientific contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Franco Ionna
Public contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Franco Ionna
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 96 | 15 |
| Rest of world | — | 0 | — |
Investigational sites
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC Chirurgia Maxillo-Facciale e ORL, Via Mariano Semmola 52, 80131, Naples
AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette
General Surgery, C.so Bramante 88, 10126, Torino
Ospedale Mons. Raffaele Dimiccoli, Barletta
General Surgery, Viale Ippocrate, 70051, Barletta
Casa Sollievo Della Sofferenza
General Surgery, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Central Hospital Of Bolzano
General Surgery, Via Lorenz Boehler 5, 39100, Bolzano
Azienda Ospedaliero-Universitaria Policlinico Umberto I
General Surgery, Viale Del Policlinico 155, 00161, Rome
Azienda Unita Sanitaria Locale Di Piacenza
General Surgery, Via Giuseppe Taverna 49, 29121, Piacenza
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Medical Oncology, Piazzale Spedali Civili 1, 25123, Brescia
Fondazione IRCCS Policlinico San Matteo
surgery science, Viale Camillo Golgi 19, 27100, Pavia
Ospedale "A. Perrino"
General Surgery, Strada Statale 7 (APPIA), 72100, Brindisi
I.F.O. Istituti Fisioterapici Ospitalieri
General Surgery, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliera Universitaria Mater Domini
General Surgery, Viale Tommaso Campanella, 115, Catanzaro
Azienda USL IRCCS Di Reggio Emilia
General Surgery, Via Giovanni Amendola 2, 42122, Reggio Emilia
Ospedale San Vincenzo Taormina
General Surgery, Contrada Sirina, 98039, Taormina (ME)
Nuovo Ospedale di Prato-S. Stefano
General Surgery, Via Suor Niccolina Infermiera, 88100, Catanzaro
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Prot ECT HN V1_2 _16 nov 2020_red | 1.2 |
| Recruitment arrangements (for publication) | Blank Document | 1 |
| Subject information and informed consent form (for publication) | Consenso al trattamento dei dati V1 del 18 Jun 18_red | 1 |
| Subject information and informed consent form (for publication) | Consenso informato 16 nov 2020 clean | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | Bleoprim RCP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Cetuximab RCP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | FLUOROURACILE_RCP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Pembrolizumab_RCP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP Carboplatino | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP_Cisplatino | 1 |
| Synopsis of the protocol (for publication) | Sinossi ECT HN 16 nov 2020_red | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-29 | Italy | Acceptable with conditions 2025-01-30
|
2025-01-31 |