All studies
RecruitingNAINTERVENTIONAL

Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)

This research is investigating a quicker type of radiation therapy for women with early breast cancer. Currently, some patients receive radiation over several days. This study explores if giving the entire radiation dose in a single treatment session is safe and effective. The main goals are to see how well it treats the cancer, if it causes fewer side effects later on, and how the treated breast looks afterwards. If successful, this single-session approach could make radiation treatment much more convenient for suitable patients, reducing hospital visits and overall treatment time, while still aiming for excellent outcomes.

At a glance

Status
Recruiting
Phase
NA
Sponsor
National Institute of Oncology, Hungary
Enrolment target
250
Start
01 Jul 2025
Estimated completion
01 Aug 2032

What is this study about?

This study is about finding a new, quicker way to give radiation treatment to women who have had surgery for early-stage breast cancer. Usually, after breast cancer surgery, some patients need radiation to help stop the cancer from coming back in the treated area. This radiation can involve several separate sessions over a number of days.

Over time, doctors have found ways to shorten this. For example, some treatments already give radiation over just two days. This new study takes that idea even further, trying to see if giving all the radiation in one single session – on one day – is just as safe and effective. The main things the study wants to find out are how well it works to control the cancer, what any long-term side effects might be, and how the breast looks after this treatment.

The hope is that if this single-session treatment works well, it could be a much more convenient option for suitable patients. It would mean fewer hospital visits, less time spent in treatment, and potentially less disruption to daily life, while still giving the best possible care for early breast cancer.

Key takeaways

  • New study aims for one-day radiation for early breast cancer.
  • Could reduce hospital visits and treatment time significantly.
  • Researchers will check how well it works, side effects, and breast appearance.
  • Only for specific types of early-stage breast cancer.
  • This is a research study, carefully evaluating a new approach.

Who may be eligible?

This study is for women who have been diagnosed with early breast cancer, specifically very small cancers that haven't spread much. Your cancer must be limited to the breast, and your lymph nodes (glands in your armpit) should either be clear or have only tiny amounts of cancer cells.

To be considered, your cancer needs to be a certain size (less than 3cm) and must have been completely removed during surgery, with clear edges (meaning no cancer cells were left behind). You should also be over 40 years old. There are specific types of breast cancer that are included, and if you have HER2-positive cancer, you'll need to be receiving treatment for that already.

However, this study isn't suitable for everyone. If your cancer is more advanced, if it has spread to distant parts of your body, or if you have specific types of breast cancer that are known to be more aggressive, you might not be able to join. Also, if you're pregnant or breastfeeding, or if you've had breast cancer before, this study wouldn't be right for you.

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.

  1. My breast cancer is considered early-stage.
  2. My cancer is smaller than 3 centimetres.
  3. My lymph nodes are either clear or have only tiny cancer cells.
  4. My surgeon removed all the cancer with clear edges.
  5. I am over 40 years old.
  6. I am not pregnant or breastfeeding.
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of your treatment would involve a single radiation session. This means you would receive your radiation therapy in one visit, rather than over several. After this main treatment, the study team would follow your progress over time to see how well the treatment worked and to check for any side effects. This would involve regular check-ups, which might include examinations and imaging tests (like mammograms), but these are standard follow-up care that you would receive anyway after breast cancer treatment. The overall duration of your participation would involve these follow-up visits, as doctors want to see the long-term results of this new treatment method.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of a much shorter and more convenient radiation treatment, meaning fewer hospital visits and less time away from your daily life. However, as this is a new approach, there's always a possibility of unknown side effects or that it might not be as effective as current standard treatments. The study aims to carefully monitor all participants for any side effects. You are always free to withdraw from the study at any time without giving a reason, and your medical care will not be affected if you choose to do so.

Locations (22)

  • Centre Léon Bérard
    Verified postcode
    Lyon, France· Not yet recruiting
  • Institut de Cancérologie de Lorraine
    Verified postcode
    Nancy, France· Not yet recruiting
  • Antoine Lacassagne Cancer Centre
    Verified postcode
    Nice, France· Not yet recruiting
  • Klinikum Bremerhaven
    Verified postcode
    Bremerhaven, Germany· Not yet recruiting
  • University Hospital Erlangen
    Verified postcode
    Erlangen, Germany· Not yet recruiting
  • Universitätsklinikum Schleswig-Holstein
    Verified postcode
    Lübeck, Germany· Not yet recruiting
  • Sana Klinikum Offenbach
    Verified postcode
    Offenbach, Germany· Not yet recruiting
  • Universitätsklinikum Würzburg
    Verified postcode
    Würzburg, Germany· Not yet recruiting
  • National Institute of Oncology
    Verified postcode
    Budapest, Hungary· Recruiting
  • National Cancer Institute
    Verified postcode
    Vilnius, Lithuania· Not yet recruiting
  • Maria Skłodowska-Curie Bialystok Oncology Center
    Verified postcode
    Bialystok, Poland· Not yet recruiting
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny
    Verified postcode
    Brzozów, Poland· Not yet recruiting

Common questions

What is 'single-fraction' radiation?

It means receiving your entire radiation treatment in one single session, rather than several over multiple days.

Why are doctors looking at this shorter treatment?

The aim is to make radiation treatment more convenient for patients, reducing hospital visits while still providing effective care for early breast cancer.

Will this treatment hurt?

Radiation therapy itself doesn't cause pain during the treatment. You might experience some skin irritation or tiredness afterwards, similar to standard radiation.

How will they know if it works?

The study will carefully follow participants over time to check for any return of cancer, look at side effects, and see how the treated breast heals and looks.

Is this a new type of radiation?

It uses established radiation techniques but delivers the treatment in a much shorter timeframe (one session) than is currently standard, for suitable patients.

How to find out more

Viktor Smanykó, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Single-Fraction Very Accelerated Partial Breast Irradiation …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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