Electrochemotherapy versus conventional surgery in treatment of basal cell carcinoma

Phase 1

Active, not recruiting

• Conditions: Basal cell carcinoma of the skin; MedDRA version: 12.1Level: LLTClassification code 10024542Term: Lip basal cell carcinoma; MedDRA version: 12.1Level: LLTClassification code 10027492Term: Metatypical basal cell carcinoma; MedDRA version: 12.1Level: LLTClassification code 10035029Term: Pigmented basal cell carcinoma; MedDRA version: 12.1Level: LLTClassification code 10004146Term: Basal cell carcinoma; MedDRA version: 12.1Level: LLTClassification code 10004149Term: Basal cell carcinoma skin excision; MedDRA version: 12.1Level: LLTClassification code 10004148Term: Basal cell carcinoma excision; MedDRA version: 12.1Level: LLTClassification code 10029496Term: Nodulo-ulcerative basal cell carcinoma; MedDRA version: 12.1Level: LLTClassification code 10042503Term: Superficial basal cell carcinoma; MedDRA version: 12.1Level: LLTClassification code 10062787Term: Morphoeaform basal cell carcinoma

• Registration Number: EUCTR2010-019260-37-IE
• Lead Sponsor: Cork Cancer Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-09
• Study Completion: 2013-01-01
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Patients with diagnosed Basal Cell Carcinoma
•Age =18 years old
•Performance status: Karnofsky =70%; WHO =2
•Patients mentally capable of understanding the information given
•Life expectancy >5 years
•Informed consent form signed

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previously treated lesions (Radiotherapy or otherwise)
•Lesions spread to other sites, including lymph nodes
•Advanced BCC where there is a question of invasion or involvement of tissue other than skin and subcutaneous tissue (bone, cartilage)
•Squamous Cell Carcinoma
•Presence of second primary cancer
•Allergy to bleomycin
•Chronic renal dysfunction
•Acute pulmonary infection
•Reduced lung function
•Coagulopathy
•Epilepsy
•Clinically manifested arrhythmia or with pacemaker
•Pregnancy or lactation
•Intention to conceive a child within 12 months after the treatment (both men and women)

Study & Design

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