Recurrent, metastatic HN cancer or primary cancer in patients with severe co-morbidities and/or which only regular treatment with extensive morbidity is available Cancer
Conditions
Interventions
Collection of the data about tumor response, safety, toxicity, survival and quality of life (QoL) of patients submitted to intravenous administration of 15000 IU BLM/m2 within 1 min, after 8 min elect
Sponsors
IRCCS Policlinico San Matteo Foundation (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically verified cancer of any type 2. Progressive and/or metastatic disease 3. Primary disease not eligible for surgery for patient’s general conditions or for the need of extensive surgery 4. Patients must have offered standard treatments 5. Measurable lesions suitable for application of electric pulses 6. Age> 18 yrs 7. Performance status (Karnofsky = 70; WHO = 2) 8. Life expectancy> 3 months 9. Treatment free interval of at least 4 weeks after previously applied chemo- or radiotherapyto the target lesions 10. Patients must be mentally capable of understanding the information given and sign informed consent
Exclusion criteria
Exclusion criteria: 1. Other symptomatic lesions not under control 2. Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.) 3. Acute lung infection 4. Symptoms of poor lung function necessitates DLCO and patient can not be treated if this is abnormal 5. Severe coagulation disorders not correctable 6. Previous allergic reactions to bleomycin 7. If cumulative dose of 240000 IU BLM/m2 was previously exceeded 8. Chronic renal dysfunction (creatinine> 150 µmol/L) 9. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of tumor response (only one target lesion) at 2 months after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety (toxicity) of the procedure 2. Analysis of overall and progression free survival 3. “Quality of life” (EORTC QLQ-C30, EORTC QLQ-H&N35, EQ_5D) The evaluation of the secondary aims will be performed at each follow-up visit till one year of follow up in case of complete responders or till the last follow up visit before exit the protocol in case of partial responders, stable or progressive disease or death or patient unwilling/unable to continue follow-up. | — |
Countries
Denmark, Italy, Netherlands, Slovenia, Spain, United Kingdom
Outcome results
None listed