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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN78463063
• Date of registration: 17/03/2015
• Prospective Registration: No
• Primary sponsor: IRCCS Policlinico San Matteo Foundation (Italy)
• Public title: EURECA (European research on electrochemotherapy in head and neck cancer) project
• Scientific title: Local treatment of HN cancer by electrochemotherapy. Analysis of the efficacy of the procedure in tumor control and survival
• Date of first enrolment: 01/11/2011
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN78463063
• Study type: Observational
• Study design: Phase II observational study (Treatment)

Countries of recruitment

Denmark, Italy, Netherlands, Slovenia, Spain, United Kingdom

Contacts

• Name: Giulia Bertino

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 electroporation (with Cliniporator and specific electrodes) of the lesion with a 1 cm of safe margin. Procedure has to be finished within 30 min.

4 weeks after procedure:
1. CT or MRI (same imaging as pre-operative evaluation)
2. Evaluation of tumor response in accordance with RECIST criteria (version 1.1)
3. Photographic documentation
4. QOL assessments (EORTC QLQ-C30, EORTC QLQ-H&N35, EQ_5D)
5. In case of residual disease a second ECT can be considered (if residual disease after the 2nd ECT other treatment options must be considered).

8 weeks after procedure:
1. CT or MRI and PET-CT
2. Evaluation of tumor response in accordance with RECIST criteria (version 1.1)
3. Photographic documentation
4. QOL assessments (EORTC QLQ-C30, EORTC QLQ-H&N35, EQ_5D)
5. Biopsy on indication
6. In case of residual disease a second ECT can be considered (if residual disease after the 2nd ECT other treatment options must be considered).
7. All the CR must be followed up at 4, 8, 12 months after treatment

Primary Outcome(s)

Evaluation of tumor response (only one target lesion) at 2 months after the procedure

Secondary Outcome(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

IRCCS Policlinico San Matteo Foundation (Italy)