Electrochemotherapy versus conventional surgery in treatment of basal cell carcinoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019260-37-IE

Enrollment

100

Registered

2010-06-09

Start date

2010-07-21

Completion date

Unknown

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal cell carcinoma of the skin MedDRA version: 12.1 Level: LLT Classification code 10004146 Term: Basal cell carcinoma MedDRA version: 12.1 Level: LLT Classification code 10004148 Term: Basal cell carcinoma excision MedDRA version: 12.1 Level: LLT Classification code 10004149 Term: Basal cell carcinoma skin excision MedDRA version: 12.1 Level: LLT Classification code 10024542 Term: Lip basal cell carcinoma MedDRA version: 12.1 Level: LLT Classification code 10027492 Term: Metatypical basa

Interventions

Trade Name: Bleomycin Product Name: Bleomycin Product Code: Electrochemotherapy Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: BLEOMYCIN SULFATE CAS Number: 9041934 Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this clinical study is to compare results of treatment of Basal Cell Carcinoma using electrochemotherapy and conventional surgical excision. The surgery has to be carried out in a theatre under general anaesthesia. It involves not only surgeon but also anaesthetist and theatre personnel. It is time consuming. Electrochemotherapy is carried out in a procedure room, usually under sedation and local anaesthesia. It involves a surgeon and a single nurse. The whole procedure takes in average 20min. It is less invasive and carries minor risk of local complications. ;Secondary Objective: We plan to compare: - outcome of treatment - recurrence rate - cosmetic effect - total cost - duration of procedure - patients’ distress - patients’ satisfaction ;Primary end point(s): Aim is to treat a group of 50 patients with electrochemotherapy and 50 patients with conventional surgery. Patients are assigned to the groups in a random manner. The study should end in June 2011. That will be followed by systematic reviews of patients post treatment for a period of 5 years.	—

Measure

Time frame

Main Objective: The aim of this clinical study is to compare results of treatment of Basal Cell Carcinoma using electrochemotherapy and conventional surgical excision. The surgery has to be carried out in a theatre under general anaesthesia. It involves not only surgeon but also anaesthetist and theatre personnel. It is time consuming. Electrochemotherapy is carried out in a procedure room, usually under sedation and local anaesthesia. It involves a surgeon and a single nurse. The whole procedure takes in average 20min. It is less invasive and carries minor risk of local complications. ;Secondary Objective: We plan to compare: - outcome of treatment - recurrence rate - cosmetic effect - total cost - duration of procedure - patients’ distress - patients’ satisfaction ;Primary end point(s): Aim is to treat a group of 50 patients with electrochemotherapy and 50 patients with conventional surgery. Patients are assigned to the groups in a random manner. The study should end in June 2011. That will be followed by systematic reviews of patients post treatment for a period of 5 years.

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Countries

Ireland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026