Electrochemotherapy as a first line treatment in recurrent squamous cell carcinoma of the oral cavity and oropharynx: a randomized controlled trial (ECT-HN)

Phase 2

Not yet recruiting

• Conditions: CARCINOMA OF THE ORAL CAVITY AND OROPHARYNX

• Registration Number: 2025-520735-16-00
• Lead Sponsor: IRCCS Istituto Nazionale Tumori Fondazione Pascale

Brief Summary

Superiority of the treatment of Electrochemotherapy with Bleomycin in terms of objective response compared to the treatment with cetuximab + platinum-based therapy + 5-fluorouracil

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

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

1. Age<18 years;

2. Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin)

3. Any severe and uncontrolled systemic illness

4. 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)

5. Other symptomatic lesions not under control;

6. Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.);

7. Injectable lesions for systemic treatment with cetuximab + platinum + 5-fluorouracil therapy

8. Acute lung infection;

9. Symptoms of poor lung function;

10. Non correctable severe coagulation disorders;

11. Previous allergic reactions to bleomycin;

12. Previous cumulative dose of 250 mg/m2 of bleomycin exceeded;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Superiority of electrochemotherapy treatment with bleomycin in terms of objective response compared to treatment with cetuximab + platinum-based therapy + 5-fluorouracil.		Superiority of electrochemotherapy treatment with bleomycin in terms of objective response compared to treatment with cetuximab + platinum-based therapy + 5-fluorouracil.

Secondary Outcome Measures

Name	Time	Method
Overall survival		Overall survival
Assessment of disease-free progression time between the two groups		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		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		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		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

Trial Locations

Locations (15)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Ospedale "A. Perrino"; 🇮🇹 Brindisi, Italy

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia; 🇮🇹 Brescia, Italy

Azienda Unita Sanitaria Locale Di Piacenza; 🇮🇹 Piacenza, Italy

Azienda Ospedaliera Universitaria Mater Domini; 🇮🇹 Catanzaro, Italy

Nuovo Ospedale di Prato-S. Stefano; 🇮🇹 Catanzaro, Italy

Azienda USL IRCCS Di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

Ospedale San Vincenzo Taormina; 🇮🇹 Taormina (ME), Italy

I.F.O. Istituti Fisioterapici Ospitalieri; 🇮🇹 Rome, Italy

IRCCS Istituto Nazionale Tumori Fondazione Pascale; 🇮🇹 Naples, Italy

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Fondazione IRCCS Policlinico San Matteo

🇮🇹Pavia, Italy

Marco Benazzo

Site contact

0382526239

m.benazzo@smatteo.pv.it