Study Comparing Electrochemotherapy with Bleomycin to Standard Radiotherapy for Treating Basal Cell Carcinoma in Patients with Tumors Less Than 3 cm

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What is this study about?

This clinical trial is focused on studying the treatment of basal cell carcinoma, a common type of non-melanoma skin cancer. The study will compare two treatments: electrochemotherapy and standard radiotherapy. Electrochemotherapy is a method that combines chemotherapy with electrical pulses to enhance the effect of the drug on cancer cells. The chemotherapy drug used in this study is called Bleomycin, which is administered as a solution for injection or infusion directly into the tumor.

The purpose of the study is to compare the effects of electrochemotherapy with those of standard radiotherapy in treating basal cell carcinomas that are less than 3 cm in size. Participants in the study will receive either electrochemotherapy or radiotherapy, and the effects of these treatments will be observed and compared. The study will also monitor any side effects, the cosmetic outcomes of the treatments, and the satisfaction of the participants with the treatment they receive.

The study will take place over several years, with participants being monitored throughout the treatment process. The goal is to determine which treatment is more effective and to gather information on the overall experience of the participants. This information will help in understanding the best approach to treating basal cell carcinoma in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the basal cell carcinoma is less than 3 cm and accessible for both treatments.

A biopsy is performed to confirm the diagnosis of basal cell carcinoma.

2 treatment allocation

Participants are randomly assigned to one of two treatment groups: electrochemotherapy or standard radiotherapy.

The allocation is done to compare the effectiveness of the two treatments.

3 electrochemotherapy treatment

For those in the electrochemotherapy group, the treatment involves the use of bleomycin, administered directly into the tumor.

The medication is given as a solution for injection or infusion, specifically targeting the tumor site.

4 standard radiotherapy treatment

Participants in the standard radiotherapy group receive radiation treatment aimed at the tumor.

The frequency and duration of the radiotherapy sessions are determined by the study protocol.

5 monitoring and follow-up

Throughout the study, participants are monitored for the effectiveness of the treatment and any adverse events.

Regular follow-up appointments are scheduled to assess cosmesis (the appearance of the treated area) and patient satisfaction.

6 study completion

The study is estimated to conclude by December 15, 2028.

Final assessments are conducted to evaluate the primary and secondary endpoints, including the overall effect of the treatments.

Who Can Join the Study?

Must be 18 years or older.
Must have a biopsy (a small sample of tissue taken for testing) that confirms basal cell carcinoma (a type of skin cancer) that is less than 3 cm in size and can be treated with both radiotherapy (treatment using radiation) and electrochemotherapy (a treatment combining electricity and chemotherapy).
Must be able to understand the patient information provided about the study.
Must have signed informed consent, which means agreeing to participate in the study after being informed about it.

Who Cannot Join the Study?

Patients with a type of skin cancer called basal cell carcinoma that is larger than 3 cm cannot participate.
Patients who have other types of skin cancer, such as melanoma, are not eligible. Melanoma is a more serious form of skin cancer.
Patients who are not within the specified age range for the study cannot join. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not allowed to participate.
Patients who have any medical condition or situation that the study doctors believe would make it unsafe or inappropriate for them to participate will be excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hazanx Hyvcxmdn	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	06.04.2021

Trial locations

Investigated drugs:

Bleomycin

Electrochemotherapy is a treatment that combines chemotherapy with electrical pulses. The electrical pulses help the chemotherapy drugs enter cancer cells more effectively. This method is used to treat basal cell carcinoma, a type of skin cancer, by enhancing the effects of the chemotherapy drugs on the cancer cells.

Standard Radiotherapy is a common cancer treatment that uses high-energy rays to target and destroy cancer cells. In this trial, it is used as a comparison to electrochemotherapy to see which method is more effective in treating basal cell carcinoma.

Investigated diseases:

Basal cell carcinoma

Basal Cell Carcinoma – Basal cell carcinoma is a type of skin cancer that begins in the basal cells, which are found in the outer layer of the skin. It typically appears as a slightly transparent bump on the skin, though it can take other forms. This cancer is most often caused by long-term exposure to ultraviolet (UV) radiation from sunlight. Basal cell carcinoma grows slowly and is unlikely to spread to other parts of the body. It can cause damage to surrounding tissues if not treated. The condition is more common in areas of the skin that are frequently exposed to the sun, such as the face and neck.

Trial ID:

2024-519066-49-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Electrochemotherapy with Bleomycin to Standard Radiotherapy for Treating Basal Cell Carcinoma in Patients with Tumors Less Than 3 cm

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?