AuthorisedTherapeutic exploratory (Phase II)Interventional

Electrochemotherapy with Carboplatinum plus Bleomycin versus Bleomycin alone in vulvar cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial

This research study, called the ElechtraPlatinum Study, is investigating a new treatment for vulvar cancer that has returned after someone has already had many other treatments. The study is comparing two different approaches to electrochemotherapy. One group of participants will receive electrochemotherapy using two medicines together: Carboplatin and Bleomycin. The other group will receive electrochemotherapy using only Bleomycin. Researchers want to find out which of these treatments is more effective at controlling the cancer in the area where it first appeared. This is a Phase II study, meaning it's an early stage trial looking to see how well the treatment works and if it's safe for people.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

Enrolment target

Start

27 Nov 2024

relapsing vulvar carcinoma already subjected to multiple treatments

What is this study about?

Imagine you have vulvar cancer, and it's come back even after you've had various treatments before. This can be very worrying. This study is looking into a treatment called electrochemotherapy, which uses small electrical pulses to help cancer-fighting medicines get into the cancer cells more effectively. The hope is that this can help control the cancer in the area where it is.

Specifically, this study wants to see if using two medicines together – Carboplatin and Bleomycin – with electrochemotherapy is better than using just Bleomycin with electrochemotherapy. Bleomycin is a medicine often used in cancer treatment, and Carboplatin is another type of chemotherapy. By combining them, the researchers hope to find a more powerful way to fight the cancer locally.

The main goal is to see if one treatment works better at keeping the cancer from growing or spreading in the local area. This is a "Phase II" study, which means it's an important step to understand if these treatments are safe and show promise before they might be tested in a larger number of people. It’s about finding better ways to help people whose vulvar cancer has returned.

Key takeaways

This study explores a new electrochemotherapy approach for returning vulvar cancer.
It compares two medicine combinations: Carboplatin plus Bleomycin versus Bleomycin alone.
The goal is to find a better way to control the cancer locally.
This is a Phase II study, checking effectiveness and safety in an early stage.
Participants must be adult women with relapsed vulvar cancer after multiple previous treatments.
Participation involves treatment sessions, tests, and follow-up appointments.

Who may be eligible?

This study is looking for women who have vulvar cancer that has returned (relapsed) even after they have had multiple other treatments for it. You would need to be at least 18 years old to take part; there is no upper age limit.

Before joining, doctors will carefully check your overall health and your specific cancer details to make sure this study is right for you and that taking part would be safe. They will go through a detailed list of health conditions and previous treatments to see if you meet all the necessary requirements.

It’s important to remember that not everyone with a type of cancer can join every study. These rules are in place to ensure the safety of participants and to make sure the study can give clear answers about the treatment being tested.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult woman (18 years or older)?
Have you been diagnosed with vulvar cancer that has come back?
Have you already received several other treatments for your vulvar cancer?
Are you generally well enough to undergo cancer treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two treatment groups: either electrochemotherapy with both Carboplatin and Bleomycin, or electrochemotherapy with only Bleomycin. Being 'randomly assigned' means it's like a coin toss; neither you nor your doctor chooses which group you're in, which helps make the study fair.

Your involvement would include regular hospital visits for treatment sessions and various tests. These tests might include blood samples, physical examinations, and scans to check on your health and how the treatment is working against your cancer. You would also have follow-up visits after your treatment finishes to monitor your progress.

The total length of time you would be involved in the study, including treatment and follow-up, would be fully explained by the study team. It's important to understand this commitment before you agree to participate.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving close medical attention and access to a new treatment approach that might be more effective than existing options for your specific condition. However, there are also potential risks. The treatments being studied, Carboplatin and Bleomycin, are medicines known to have side effects, which can vary from mild to severe, and the electrical pulses used in electrochemotherapy can also have effects. All possible side effects and discomforts will be fully explained before you decide to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Italy

Common questions

What is vulvar cancer?

Vulvar cancer is a rare type of cancer that forms on the surface of the outer female genitals, called the vulva.

What is electrochemotherapy?

Electrochemotherapy uses short, weak electrical pulses to temporarily open up cancer cells, helping chemotherapy medicines enter them more effectively to kill the cancer.

What does 'relapsing' mean?

Relapsing means that the cancer has come back after it was previously treated and had gone into remission (seemed to have disappeared).

What is a 'Phase II' study?

A Phase II study is an early stage clinical trial that tests if a new treatment is effective and safe in a small group of people, before larger studies begin.

Can I choose which treatment I get?

No, if you join, you will be randomly assigned to receive either the treatment with two medicines or the treatment with one medicine. This helps ensure the study results are fair and unbiased.