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Electrochemotherapy as a first line treatment in recurrent squamous cell carcinoma of the oral cavity and oropharynx: a randomized controlled trial (ECT-HN)
EU CTIS ID: 2025-520735-16-00
What this study is testing
Superiority of the treatment of Electrochemotherapy with Bleomycin in terms of objective response compared to the treatment with cetuximab + platinum-based therapy + 5-fluorouracil
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 1. Age<18 years;
- 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)
- 2. Other symptomatic lesions not under control;
- 3. Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.);
See the full eligibility 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
- 1. Age<18 years;
- 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)
- 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;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.