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

Phase 1

• Conditions: carcinoma of the oral cavity and oropharynx; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003589-15-IT
• Lead Sponsor: ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-07
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1.Age> 18 yrs;
2.Progressive disease (recurrence on T and N0) of oral cavity or oropharynx
3.Histologically verified squamous cell carcinoma;
4. Measurable lesions suitable for application of electric pulses;
5.Performance status (Karnofsky = 70; WHO = 2);
6.Life expectancy> 3 months;
7.Patients must be mentally capable of understanding the information given and sign informed consent;
8.Patients must have offered standard treatments.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Age<18 yrs;
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)

Study & Design

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