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

March 19, 2024 updated by: Juergen Dunst, Prof., University Hospital Schleswig-Holstein

Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation

Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible.

Investigators initiated this multicenter two-armed phase III prospective trial to analyse the non-inferiority of hypofractionation with simultaneous integrated boost in patients with early breast cancer in comparison to standard fractionation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Control Arm:

Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 60.4 Gy to 66.4 Gy.

or Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy with simultaneous integrated boost to the tumor bed, total dose 28 × 0.3 Gy or 0.45 Gy= 8.4 Gy or 12,6 Gy, total dose 58,8 Gy to 63.0 Gy.

or Hypofractionated radiotherapy of the breast 16 × 2.66 Gy = 42.56 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 52.56 Gy to 58.56 Gy.

Experimental Arm:

Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed, total dose within the boost volume 16 × 3.00 Gy.

Study Type

Interventional

Enrollment (Actual)

2324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Amberg, Germany, 92224
        • Gesundheitszentrum St.Marien Gmbh und Klinik für Strahlentherapie
      • Aue, Germany, 08280
        • Medizinisches Versorgungszentrum Aue
      • Bad Saarow, Germany, 15526
        • Helios Klinikum Bad Saarow
      • Bad Saarow, Germany, 15526
        • Helios Kliniken Bad Saarow Klinik für Radioonkologie
      • Bayreuth, Germany, 95445
        • Strahlentherapie Klinikum Bayreuth
      • Berlin, Germany, 10243
        • Medizinisches Versorgungs Zentrum Diagnostisch Therapeutisches Zentrum am Frankfurter Tor
      • Berlin, Germany, 10559
        • Strahlentherapie in Moabit /Praxis für Strahlentherapie
      • Berlin, Germany, 12157
        • Praxis für Radioonkologie und Strahlentherapie Berlin Südwest
      • Berlin, Germany, 12200
        • Ambulantes Gesundheitszentrum der Dr. med Maria Sternemann Charte -Universitätsmedizin Berlin
      • Berlin, Germany, 12351
        • Vivantes-Klinikum Berlin-Neukölln
      • Berlin, Germany, 13125
        • HELIOS Klinikum Berlin-Buch, Strahlentherapeutische Klinik
      • Berlin, Germany, 13353
        • Charite berlin (Virchow) Klinik für Strahlentherapie
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin: Zentrum für Strahlentherapie MVZ pro patiente Westend
      • Berlin, Germany, 14165
        • MZV am HELIOS Klinikum Emil von Behring
      • Berlin ( Mitte), Germany, 10249
        • MVZ Chariete Vivantes Gmbh Strahlentherapie
      • Bocholt, Germany, 46399
        • Gemeinschaftspraxis und Belegabteilung für Strahlentherapie
      • Bremen, Germany, 28205
        • Ambulanz Bremen GMBH MVZ RadioOnkologie
      • Bremen, Germany, 28239
        • Zentrum für Strahlentherapie undRadioonkologie
      • Buchholz, Germany, 21244
        • Krankenhaus Buchholz Abteilung für Strahlentherapie
      • Coesfeld, Germany, 48653
        • Strahlentherapie Coesfeld
      • Deggendorf, Germany, 94469
        • Radiologie Strahlentherapie-Zweigpraxis vom MVZ Passau
      • Dresden, Germany, 01067
        • Praxis für Strahlentherapie Krankenhaus Dresden-Friedrichsstadt
      • Duisburg, Germany, 470530
        • Malteser MVZ Duisburg-Süd
      • Dusseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf Klinik und Poliklinik für Strahlentherapie und Radioologische Onkologie
      • Elmshorn, Germany, 25337
        • Gemeinschaftspraxis für Strahlentherapie und Radioonkologie
      • Esslingen, Germany, 73730
        • MVZ Strahlentherapie Klinikum Esslingen GmbH
      • Frankfurt/M, Germany, 60590
        • Klinik für Strahlentherapie und Onkologie
      • Frankfurt/Oder, Germany, 15236
        • Klinikum Frankfurt (Oder)Klinikum für Strahlentherapie Radioonkologie
      • Fürth, Germany, 90766
        • Strahlentherapie am Klinikum Fürth
      • Gelsenkirchen, Germany, 45899
        • Strahlentherapiezentrum- Escher-Lippe(STZELL) und die Katholischen Kliniken-Emscher
      • Gießen, Germany, 35392
        • Justus-Liebig Universität Gießen Strahlentherapie
      • Goch, Germany, 47574
        • Praxis für Strahlentherapie Goch
      • Göppingen, Germany, 73035
        • Brustzentrum ALB FILS Kliniken GMBH
      • Hamburg, Germany, 20246
        • Ambulanzzentrum des UKE GmbH Bereich der Strahlentherapie
      • Hamburg, Germany, 22307
        • Radiologische Ambulanz Fachärzte für Radiologie,Nuklearmedizin und Strahlentherapie
      • Hamburg, Germany, 22419
        • Strahlenzentrum Hamburg
      • Hamburg Harburg, Germany, 21075
        • Dr.med Jürgen Heide Facharzt für Strahlentherapie
      • Hameln, Germany, 31785
        • GSR Hameln
      • Hannover, Germany, 30161
        • Gemeinschaftspraxis für Strahlentherapie und Radioonkologie / Hannover/Hildesheim/Hameln
      • Hannover, Germany, 30449
        • GSR Hannover Siloa
      • Hildesheim, Germany, 31134
        • Gemeinschaftspraxis für Strahlentherapie und Radioonkologie(GSR)
      • Hildesheim, Germany, 31135
        • Gemeinschaftspraxis für Strahlentherapie Hildesheim/Goslar
      • Hildesheim, Germany, 31135
        • Gemeinschaftspraxis für Strahlentherapie/Hildesheim/Goslar
      • Hof, Germany, 95032
        • Strahlentherapie Hof
      • Karlsruhe, Germany, 76135
        • MVZ St. Vincent-Kliniken gAG
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • Kiel, Germany, 24105
        • Praxis für Strahlentherapie am Universitätsklinikum Schleswig-Holstein
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leibzig
      • Lemgo, Germany, 32657
        • Klinikum für Strahlentherapie - Klinikum Lippe
      • Ludwigsburg, Germany, 71640
        • Klinikum Ludwigsburg Klinik für Radioonkologie
      • Lüneburg, Germany, 21339
        • Klinikum Lüneburg, Klinik für Strahlentherapie und Radioonkologie
      • Lünen, Germany, 44534
        • MVZ Prof.Dr.Uhlenbrock und Partner Strahlentherapie Lünen
      • Mainz, Germany, 55131
        • Klinik und Poliklinik für Radioonkologie und Strahlentherapie Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Mannheim, Germany, 68309
        • Praxis für Strahlentherapie Mannheim
      • Marburg, Germany, 35033
        • Universitätsklinikum Marburg Strahlentherapie und Radioonkologie
      • Meiningen, Germany, 98617
        • Brustzentrum Helios Klinikum
      • Monchengladbach, Germany, 41063
        • Kliniken Maria Hilf Gmbh Klinik für Strahlentherapie
      • Muenchen, Germany, 81675
        • Klinikum rechts der Isar
      • Münster, Germany, 48149
        • Klinik für Strahlentherapie- Radioonkologie
      • Münster, Germany, 48153
        • Praxis für Strahlentherapie und Radioonkologie am Clemenshospital
      • Neckarsulm, Germany, 74172
        • Strahlentherapie Neckarsulm
      • Neubrandenburg, Germany, 17022
        • Dietrich Bonhoeffer Klinikum Neubrandenburg
      • Neunkirchen, Germany, 66538
        • Praxis für Strahlentherapie Im Städtischen Klinikum Neunkirchen
      • Oldenburg, Germany, 26121
        • Klinik für Strahlentherapie und Radioonkologie Pius-Hospital Oldenburg
      • Osnabrück, Germany, 49076
        • Zentrum für Strahlentherapie Rheine-Osnabrück
      • Passau, Germany, 94032
        • MVZ Radio-LOG Schie in Altötting
      • Pinneberg, Germany, 25421
        • Visiorad - Bereich Strahlentherapie
      • Potsdam, Germany, 14467
        • Klinikum für Radioonkologie Klinikum Ernst von Bergmann
      • Regensburg, Germany, 93049
        • Krankenhaus Barmherzige Brüder Regensburg Medizinisches Versorgungszentrum
      • Rheine, Germany, 48431
        • Überörtliche Gemeinschaftspraxis/Fachärzte für Strahlentherapie
      • Ruit, Germany, 73760
        • Kreiskliniken Esslingen Paracelsus Krankenhaus Ruit
      • Saarbrucken, Germany, 66113
        • CaritasKlinikum Saarbrücken
      • Saarlouis, Germany, 66740
        • XCare Praxis für Strahlentherapie
      • Schweinfurt, Germany, 97422
        • MVZ Leopoldina Strahlentherapie
      • Schweinfurt, Germany, 97422
        • MVZ Leopoldina
      • Schwerin, Germany, 19055
        • Helios Kliniken Schwerin GmbH
      • Stendal, Germany, 39576
        • Johanniter Zentren für medizinische Versorgung in der Altmark GMBH
      • Stendal, Germany, 39576
        • Johanniter Zentrum für Medizinische Versorgung
      • Straubing, Germany, 94315
        • MVZ Klinikum Straubing GMBH Strahlentherapie
      • Stuttgart, Germany, 70176
        • MVZ-Uniklinik Tübingen gGmbH
      • Trier, Germany, 54293
        • Praxis für Strahlentherapie Trier Ehrang
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
      • Ulm, Germany, 89081
        • Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Ulm
      • Villingen-Schwenningen, Germany, 78052
        • Klinik für Strahlentherapie und Radioonkologie Schwarzwald-Baar -Klinikum
      • Weilheim, Germany, 82362
        • Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
      • Wolfsberg, Germany, 38440
        • Medizinisches Versorgungszentrum Wolfsburg GmbH
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg Klinik und Poliklinik für Strahlentherapie
      • Zwickau, Germany, 08060
        • Heinrich-Braun-Klinikum Zwickau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, Her-2/neu status uPA/PAI-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated)
  • Indication to adjuvant radiotherapy including boost radiotherapy
  • Clearly identified primary tumor region preferably by radiopaque clips
  • Primary wound healing after breast conserving therapy without signs of infection
  • Age ≥ 18 years
  • ECOG ≤ 2 Performance Status
  • Written informed consent
  • Compliance regarding treatment appointments and toxicity
  • Linguistic and cognitive ability to understand the questionnaires

Exclusion Criteria:

  • Patients operated by mastectomy
  • No indication for boost radiation (e.g. status after IORT)
  • double sided breast cancer
  • Resection margins positive for disease or insufficient identification of the boost volume
  • Indication for radiotherapy of the regional lymph nodes
  • History of prior breast or thoracic radiotherapy
  • Extended postoperative seroma at the beginning of radiotherapy
  • Previously administered radiotherapy not allowing the required dose
  • Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
  • treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment.
  • Patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard radiation

Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or

Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or

Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially
Radiation: Standard Radiation

Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or

Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or

Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially
Experimental: Hypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
Radiation: Hypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 3 to 6 years
any local or regional recurrence or distant metastasis or death
3 to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to occurence of local recurrence
Time Frame: 3 to 6 years
ipsilateral in-breast recurrence
3 to 6 years
Overall survival
Time Frame: 3 to 6 years
death
3 to 6 years
Safety and side effects (Number of Patients with Adverse Events)
Time Frame: 3 to 6 years
Number of Patients with Adverse Events
3 to 6 years
Acute and chronic toxicity (NCI-CTCAE)
Time Frame: 1 day, 7 days, end of radiation (last day of radiation and closing visite), 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months, 66 months, 72 months
All dimensions of NCI-CTCAE
1 day, 7 days, end of radiation (last day of radiation and closing visite), 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months, 66 months, 72 months
Cosmetic results (NCI-CTCAE)
Time Frame: 1 day, end of radiation (last day of radiation and closing visite), 3 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months
NCI-CTCAE
1 day, end of radiation (last day of radiation and closing visite), 3 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Collaborators

University of Luebeck

Investigators

  • Study Chair: Jürgen Dunst, MD, University Medical Center Schleswig-Holstein (UKSH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2015

Primary Completion (Actual)

January 8, 2019

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimated)

June 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARO-2013-05, ZKS-121-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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