carcinoma of the oral cavity and oropharynx
Conditions
Interventions
Trade Name: Bleoprim
Product Name: Bleoprim
Pharmaceutical Form: Powder for injection
INN or Proposed INN: BLEOMYCIN
CAS Number: 11056-06-7
Concentration unit: IU international unit(s)
Concentration t
Sponsors
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Age 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Superiority of the treatment of Electrochemotherapy with Bleomycin in terms of objective response compared to treatment with cetuximab + therapy based on platinum + 5-fluorouracil;Secondary Objective: 1.Overall survival; 2.Evaluation of progression free survival time; 3.Evaluation of the duration of the response (the time from the first documentation of a complete or partial response until the first occurrence of disease progression or until death); 4.Evaluation of disease control, defined as complete response, partial response and stable disease between the two groups; 5.The quantification of the impact of treatment on the patient's quality of life, in terms of pain reduction and bleeding (EORTC QLQ-C30, EORTC QLQ-H&N35, EQ-5D-5L). ;Primary end point(s): To verify if the treatment with ECT and Bleomycin is superior in terms of objective response to treatment with cetuximab + therapy based on platinum + 5 fluorouracil. ;Timepoint(s) of evaluation of this end point: The clinical response will be evaluated by RECIST 1.1 criteria on CT and/or MR images at 2 months from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival; 2. Evaluation of progression free survival time; 3. Evaluation of the duration of the response (the time from the first documentation of a complete or partial response until the first occurrence of disease progression or until death); 4. Evaluation of disease control, defined as complete response, partial response and stable disease between the two groups; 5. The quantification of the impact of treatment on the patient's quality of life, in terms of pain reduction and bleeding (EORTC QLQ-C30, EORTC QLQ-H&N35, EQ-5D-5L). ;Timepoint(s) of evaluation of this end point: • CT, MR or PET / CT control at 2 months, 6 months and 12 months after treatment • Blood sampling including CD8 / CD16 assay at 1, 2, 4, 6 months as per normal clinical practice • Quality of life assessment will be at each follow-up visit | — |
Countries
Italy
Contacts
Public ContactFranco Ionna
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Outcome results
None listed