All studies
Active not recruitingNAINTERVENTIONAL

Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer

This study is looking at new ways to give radiotherapy to people with early breast cancer who have had surgery to remove the tumour. Radiotherapy uses high-energy rays to kill any remaining cancer cells. Traditionally, this is given in many small doses over several weeks (standard fractionation). This trial investigates a newer, shorter approach called 'hypofractionation with simultaneous integrated boost' (SIB). This means you get fewer, but slightly larger, doses of radiation, and some areas get a little extra boost of radiation at the same time. The main goal is to see if this shorter treatment is just as effective and safe as the traditional longer treatment. This could mean fewer hospital visits and less time in treatment for patients.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
University Hospital Schleswig-Holstein
Enrolment target
2,324
Start
16 Jun 2015
Estimated completion
31 Mar 2028

What is this study about?

This clinical trial is designed for women who have been diagnosed with early breast cancer and have had surgery to remove the tumour, but still need radiotherapy. Radiotherapy uses targeted energy to destroy any cancer cells that might have been left behind after surgery, helping to prevent the cancer from coming back.

Traditionally, radiotherapy for breast cancer involves many small daily treatments over several weeks. This study is comparing this standard approach with a newer method called 'hypofractionation with simultaneous integrated boost' (SIB). Hypofractionation means you receive fewer treatments, but each treatment is slightly stronger. The 'simultaneous integrated boost' part means that areas at higher risk of cancer coming back get a slightly higher dose during each of these shorter treatments, rather than as a separate 'boost' at the end.

The main purpose of this study is to find out if this newer, shorter treatment approach is just as effective at treating the cancer and causes similar side effects as the traditional, longer treatment. If it is, this could be a big step forward for patients, potentially leading to fewer hospital visits, less time away from daily life, and more convenient treatment while maintaining excellent care.

Key takeaways

  • This study compares two ways of giving radiotherapy for early breast cancer.
  • One method is the standard, longer treatment, the other is a shorter, more intense treatment.
  • The aim is to see if the shorter treatment is equally safe and effective.
  • Participation involves receiving one of these radiotherapy treatments and follow-up appointments.
  • It could lead to more convenient treatment options for future patients.

Who may be eligible?

This study is for women who have had surgery to remove early breast cancer and still need radiotherapy. You must be at least 18 years old, and your cancer should have been fully removed during surgery with clear edges (margins). The doctors also need to be able to clearly identify the area where the tumour was.

You would not be able to join if you had a mastectomy (where the whole breast is removed), or if the edges of the removed tumour were not clear. You also can't participate if you need radiotherapy to your lymph nodes, have had radiotherapy to your chest before, or if you are pregnant or breastfeeding. Other serious health conditions or participating in other trials that might affect this one would also prevent you from joining.

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. Have you had surgery for early breast cancer?
  2. Are you aged 18 or over?
  3. Was your tumour completely removed with clear margins during surgery?
  4. Can the doctors clearly identify where your tumour was for targeted treatment?
  5. Are you not currently pregnant or breastfeeding?
  6. Have you not had radiotherapy to your chest before?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to one of two groups: either the standard radiotherapy treatment group or the newer hypofractionated radiotherapy with integrated boost group. This would be decided randomly, like flipping a coin. Both treatments involve daily visits to the radiotherapy department, typically five days a week. You would receive a set number of treatments over a period of several weeks, depending on which group you are in. Throughout the treatment and follow-up period, you would have regular appointments to check on how you are doing, manage any side effects, and monitor your health. You will also be asked to complete questionnaires to understand how you are feeling and any side effects you might experience. The total duration of your participation in the study, including follow-up, will be explained by the study team.

Potential risks and benefits

Potential benefits could include receiving an innovative treatment that might be more convenient (fewer hospital visits) and proving that this approach is as effective as standard care, helping future patients. However, as with any medical treatment, there are potential risks and side effects from radiotherapy, which will be fully explained to you. These can include skin irritation, fatigue, or changes to the breast tissue. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (88)

  • Gesundheitszentrum St.Marien Gmbh und Klinik für Strahlentherapie
    Verified postcode
    Amberg, Germany
  • Medizinisches Versorgungszentrum Aue
    Verified postcode
    Aue, Germany
  • Helios Kliniken Bad Saarow Klinik für Radioonkologie
    Verified postcode
    Bad Saarow, Germany
  • HELIOS Klinikum Bad Saarow
    Verified postcode
    Bad Saarow, Germany
  • Strahlentherapie Klinikum Bayreuth
    Verified postcode
    Bayreuth, Germany
  • Medizinisches Versorgungs Zentrum Diagnostisch Therapeutisches Zentrum am Frankfurter Tor
    Verified postcode
    Berlin, Germany
  • Strahlentherapie in Moabit /Praxis für Strahlentherapie
    Verified postcode
    Berlin, Germany
  • Praxis für Radioonkologie und Strahlentherapie Berlin Südwest
    Verified postcode
    Berlin, Germany
  • Ambulantes Gesundheitszentrum der Dr. med Maria Sternemann Charte -Universitätsmedizin Berlin
    Verified postcode
    Berlin, Germany
  • Vivantes-Klinikum Berlin-Neukölln
    Verified postcode
    Berlin, Germany
  • HELIOS Klinikum Berlin-Buch, Strahlentherapeutische Klinik
    Verified postcode
    Berlin, Germany
  • Charite berlin (Virchow) Klinik für Strahlentherapie
    Verified postcode
    Berlin, Germany

Common questions

What is 'hypofractionation'?

It means getting fewer, but slightly stronger, radiotherapy treatments over a shorter period.

What is 'simultaneous integrated boost' (SIB)?

This is when a small, specific area (where the tumour was) gets a slightly higher dose of radiation during each of the main treatments, rather than as a separate treatment later on.

Will I know which treatment I'm getting?

No, you will be randomly assigned to either the standard or the new treatment, similar to a lottery. Neither you nor your doctor will usually choose.

Why is this study important?

It helps researchers find out if shorter, more convenient radiotherapy treatments are just as safe and effective as longer ones for early breast cancer.

Can I still have chemotherapy if I'm in this study?

Yes, other treatments for your cancer, like chemotherapy or hormone therapy, are usually allowed if your doctor thinks you need them.

How to find out more

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

Discussion

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