Comparison of Electrochemotherapy with Bleomycin and Standard Radiotherapy in the Management of Basal Cell Carcinoma Less Than 3 cm

The primary objective of this study is to compare the **effect** of electrochemotherapy versus standard radiotherapy for the treatment of **basal cell carcinoma** lesions measuring less than 3 cm. This comparison is clinically relevant as it aims to determine the more effective treatment modality for managing this common form of non-melanoma skin cancer, potentially influencing treatment guidelines and patient outcomes.

Secondary objectives include evaluating the following aspects:

• **Adverse events** associated with each treatment modality, which is crucial for assessing the safety profile of the interventions.
• **Cosmesis**, or the aesthetic outcome post-treatment, which is important for patient quality of life and satisfaction.
• **Patient satisfaction** with the treatment, providing insights into patient preferences and acceptance of the treatment options.

The clinical trial focuses on individuals diagnosed with **basal cell carcinoma**, specifically non-melanoma skin cancer, with lesions less than 3 cm. The study population includes both male and female participants, aged 18 years and older. Participants must have biopsy-verified basal cell carcinoma that is accessible for both radiotherapy and electrochemotherapy. The trial does not specify the total number of participants, as the sponsor has not provided this information. The selection process involves ensuring that subjects understand the patient information and have signed informed consent. The trial includes a vulnerable population, although specific lifestyle considerations such as diet, physical activity, or habits are not detailed in the available data.

The clinical trial is designed to evaluate the efficacy of **electrochemotherapy** compared to standard radiotherapy in the treatment of **basal cell carcinoma**. This study is structured as a Phase II/III randomized, controlled trial, ensuring a robust comparison between the two treatment modalities. The trial is double-blind to minimize bias and enhance the reliability of the results. The estimated duration of the trial spans from April 2021 to December 2028, allowing for comprehensive data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion visit where eligibility is confirmed based on criteria such as age above 18 years, biopsy-verified basal cell carcinoma under 3 cm, and the ability to provide informed consent. Following the inclusion visit, participants will be randomly assigned to receive either electrochemotherapy or standard radiotherapy. Subsequent follow-up visits will be scheduled to monitor treatment effects, adverse events, cosmesis, and patient satisfaction. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted.

The expected length of participant involvement is contingent upon the treatment schedule and follow-up period, with the maximum treatment period being one day. Conditions that may lead to early termination from the study include withdrawal of consent, significant adverse events, or any situation where continued participation is deemed unsafe by the investigator. The primary endpoint of the study is to assess the effect of electrochemotherapy versus standard radiotherapy on basal cell carcinomas less than 3 cm, with secondary endpoints including adverse events, cosmesis, and patient satisfaction.

The clinical trial involves the use of **Bleomycin**, marketed under the name "Bleomycin 'Baxter'", which is formulated as a **solution for injection/infusion**. This experimental medication is administered **intratumorally**. The maximum daily dose is set at 9000 IU, with the same amount being the maximum total dose allowed during the treatment period. The treatment period is limited to a maximum of one day. The active substance, **bleomycin**, is a mixture, and the product is not a pediatric formulation. The pharmaceutical form is a powder for solution for injection or infusion, and it is authorized for use in Denmark by Baxter A/S.

In this study, the experimental treatment with **bleomycin** is compared against standard radiotherapy, which serves as the non-experimental treatment. The trial aims to evaluate the efficacy of electrochemotherapy using **bleomycin** versus standard radiotherapy in treating basal cell carcinoma lesions that are less than 3 cm in size. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the treatment protocol.

Efficacy in the clinical trial comparing electrochemotherapy versus standard radiotherapy for the treatment of basal cell carcinoma will be assessed using specific endpoints. The primary endpoint is the effect of electrochemotherapy versus standard radiotherapy on basal cell carcinomas less than 3 cm. Secondary endpoints include the evaluation of adverse events, cosmesis, and patient satisfaction. These parameters will be measured and collected at predetermined timepoints throughout the trial duration. The analysis will focus on comparing the outcomes between the two treatment modalities to determine their relative efficacy in treating basal cell carcinoma.