EURECA (European research on electrochemotherapy in head and neck cancer) project

Completed

• Conditions: 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

• Registration Number: ISRCTN78463063
• Lead Sponsor: IRCCS Policlinico San Matteo Foundation (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-17
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified