Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer
NCT ID: NCT02474641
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2324 participants
INTERVENTIONAL
2015-06-16
2028-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Hypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
Hypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
Interventions
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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
Hypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University of Luebeck
OTHER
University Hospital Schleswig-Holstein
OTHER
Responsible Party
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Juergen Dunst, Prof.
Juergen Dunst, Prof.
Principal Investigators
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Jürgen Dunst, MD
Role: STUDY_CHAIR
University Medical Center Schleswig-Holstein (UKSH)
Locations
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Gesundheitszentrum St.Marien Gmbh und Klinik für Strahlentherapie
Amberg, , Germany
Medizinisches Versorgungszentrum Aue
Aue, , Germany
Helios Kliniken Bad Saarow Klinik für Radioonkologie
Bad Saarow, , Germany
HELIOS Klinikum Bad Saarow
Bad Saarow, , Germany
Strahlentherapie Klinikum Bayreuth
Bayreuth, , Germany
Medizinisches Versorgungs Zentrum Diagnostisch Therapeutisches Zentrum am Frankfurter Tor
Berlin, , Germany
Strahlentherapie in Moabit /Praxis für Strahlentherapie
Berlin, , Germany
Praxis für Radioonkologie und Strahlentherapie Berlin Südwest
Berlin, , Germany
Ambulantes Gesundheitszentrum der Dr. med Maria Sternemann Charte -Universitätsmedizin Berlin
Berlin, , Germany
Vivantes-Klinikum Berlin-Neukölln
Berlin, , Germany
HELIOS Klinikum Berlin-Buch, Strahlentherapeutische Klinik
Berlin, , Germany
Charite berlin (Virchow) Klinik für Strahlentherapie
Berlin, , Germany
DRK Kliniken Berlin: Zentrum für Strahlentherapie MVZ pro patiente Westend
Berlin, , Germany
MZV am HELIOS Klinikum Emil von Behring
Berlin, , Germany
Gemeinschaftspraxis und Belegabteilung für Strahlentherapie
Bocholt, , Germany
Ambulanz Bremen GMBH MVZ RadioOnkologie
Bremen, , Germany
Zentrum für Strahlentherapie undRadioonkologie
Bremen, , Germany
Krankenhaus Buchholz Abteilung für Strahlentherapie
Buchholz, , Germany
Strahlentherapie Coesfeld
Coesfeld, , Germany
Radiologie Strahlentherapie-Zweigpraxis vom MVZ Passau
Deggendorf, , Germany
Praxis für Strahlentherapie Krankenhaus Dresden-Friedrichsstadt
Dresden, , Germany
Malteser MVZ Duisburg-Süd
Duisburg, , Germany
Universitätsklinikum Düsseldorf Klinik und Poliklinik für Strahlentherapie und Radioologische Onkologie
Düsseldorf, , Germany
Gemeinschaftspraxis für Strahlentherapie und Radioonkologie
Elmshorn, , Germany
MVZ Strahlentherapie Klinikum Esslingen GmbH
Esslingen am Neckar, , Germany
Klinikum Frankfurt (Oder)Klinikum für Strahlentherapie Radioonkologie
Frankfurt (Oder), , Germany
Klinik für Strahlentherapie und Onkologie
Frankfurt/M, , Germany
Strahlentherapie am Klinikum Fürth
Fürth, , Germany
Strahlentherapiezentrum- Escher-Lippe(STZELL) und die Katholischen Kliniken-Emscher
Gelsenkirchen, , Germany
Justus-Liebig Universität Gießen Strahlentherapie
Giessen, , Germany
Praxis für Strahlentherapie Goch
Goch, , Germany
Brustzentrum ALB FILS Kliniken GMBH
Göppingen, , Germany
Ambulanzzentrum des UKE GmbH Bereich der Strahlentherapie
Hamburg, , Germany
Radiologische Ambulanz Fachärzte für Radiologie,Nuklearmedizin und Strahlentherapie
Hamburg, , Germany
Strahlenzentrum Hamburg
Hamburg, , Germany
GSR Hameln
Hamelin, , Germany
Gemeinschaftspraxis für Strahlentherapie und Radioonkologie / Hannover/Hildesheim/Hameln
Hanover, , Germany
GSR Hannover Siloa
Hanover, , Germany
Dr.med Jürgen Heide Facharzt für Strahlentherapie
Harburg, , Germany
Gemeinschaftspraxis für Strahlentherapie und Radioonkologie(GSR)
Hildesheim, , Germany
Gemeinschaftspraxis für Strahlentherapie Hildesheim/Goslar
Hildesheim, , Germany
Gemeinschaftspraxis für Strahlentherapie/Hildesheim/Goslar
Hildesheim, , Germany
Strahlentherapie Hof
Hof, , Germany
MVZ St. Vincent-Kliniken gAG
Karlsruhe, , Germany
Praxis für Strahlentherapie am Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Universitätsklinikum Leibzig
Leipzig, , Germany
Klinikum für Strahlentherapie - Klinikum Lippe
Lemgo, , Germany
Klinikum Ludwigsburg Klinik für Radioonkologie
Ludwigsburg, , Germany
Klinikum Lüneburg, Klinik für Strahlentherapie und Radioonkologie
Lüneburg, , Germany
MVZ Prof.Dr.Uhlenbrock und Partner Strahlentherapie Lünen
Lünen, , Germany
Klinik und Poliklinik für Radioonkologie und Strahlentherapie Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Praxis für Strahlentherapie Mannheim
Mannheim, , Germany
Universitätsklinikum Marburg Strahlentherapie und Radioonkologie
Marburg, , Germany
Brustzentrum Helios Klinikum
Meiningen, , Germany
MVZ Chariete Vivantes Gmbh Strahlentherapie
Mitte, , Germany
Kliniken Maria Hilf Gmbh Klinik für Strahlentherapie
Mönchengladbach, , Germany
Klinikum rechts der Isar
München, , Germany
Klinik für Strahlentherapie- Radioonkologie
Münster, , Germany
Praxis für Strahlentherapie und Radioonkologie am Clemenshospital
Münster, , Germany
Strahlentherapie Neckarsulm
Neckarsulm, , Germany
Dietrich Bonhoeffer Klinikum Neubrandenburg
Neubrandenburg, , Germany
Praxis für Strahlentherapie Im Städtischen Klinikum Neunkirchen
Neunkirchen, , Germany
Klinik für Strahlentherapie und Radioonkologie Pius-Hospital Oldenburg
Oldenburg, , Germany
Zentrum für Strahlentherapie Rheine-Osnabrück
Osnabrück, , Germany
MVZ Radio-LOG Schie in Altötting
Passau, , Germany
Visiorad - Bereich Strahlentherapie
Pinneberg, , Germany
Klinikum für Radioonkologie Klinikum Ernst von Bergmann
Potsdam, , Germany
Krankenhaus Barmherzige Brüder Regensburg Medizinisches Versorgungszentrum
Regensburg, , Germany
Überörtliche Gemeinschaftspraxis/Fachärzte für Strahlentherapie
Rheine, , Germany
Kreiskliniken Esslingen Paracelsus Krankenhaus Ruit
Ruit, , Germany
CaritasKlinikum Saarbrücken
Saarbrücken, , Germany
XCare Praxis für Strahlentherapie
Saarlouis, , Germany
MVZ Leopoldina Strahlentherapie
Schweinfurt, , Germany
MVZ Leopoldina
Schweinfurt, , Germany
Helios kliniken Schwerin GMBH
Schwerin, , Germany
Johanniter Zentren für medizinische Versorgung in der Altmark GMBH
Stendal, , Germany
Johanniter Zentrum für Medizinische Versorgung
Stendal, , Germany
MVZ Klinikum Straubing GMBH Strahlentherapie
Straubing, , Germany
MVZ-Uniklinik Tübingen gGmbH
Stuttgart, , Germany
Praxis für Strahlentherapie Trier Ehrang
Trier, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Ulm
Ulm, , Germany
Klinik für Strahlentherapie und Radioonkologie Schwarzwald-Baar -Klinikum
Villingen-Schwenningen, , Germany
Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
Weilheim, , Germany
Medizinisches Versorgungszentrum Wolfsburg GmbH
Wolfsberg, , Germany
Universitätsklinikum Würzburg Klinik und Poliklinik für Strahlentherapie
Würzburg, , Germany
Heinrich-Braun-Klinikum Zwickau
Zwickau, , Germany
Countries
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References
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Krug D, Vonthein R, Schreiber A, Boicev AD, Zimmer J, Laubach R, Weidner N, Dinges S, Hipp M, Schneider R, Weinstrauch E, Martin T, Horner-Rieber J, Olbrich D, Illen A, Hessler N, Konig IR, Dellas K, Dunst J. Impact of guideline changes on adoption of hypofractionation and breast cancer patient characteristics in the randomized controlled HYPOSIB trial. Strahlenther Onkol. 2021 Sep;197(9):802-811. doi: 10.1007/s00066-020-01730-9. Epub 2020 Dec 15.
Other Identifiers
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ARO-2013-05, ZKS-121-001
Identifier Type: -
Identifier Source: org_study_id
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