Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer
HYPOSIB
Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation
1 other identifier
interventional
2,324
1 country
88
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2015
CompletedStudy Start
First participant enrolled
June 16, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
ExpectedMarch 21, 2024
March 1, 2024
3.6 years
June 4, 2015
March 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
any local or regional recurrence or distant metastasis or death
3 to 6 years
Secondary Outcomes (5)
Time to occurence of local recurrence
3 to 6 years
Overall survival
3 to 6 years
Safety and side effects (Number of Patients with Adverse Events)
3 to 6 years
Acute and chronic toxicity (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)
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
Study Arms (2)
Standard radiation
ACTIVE COMPARATORConventionally 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
EXPERIMENTALHypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
Interventions
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
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Schleswig-Holsteinlead
- University of Luebeckcollaborator
Study Sites (88)
Gesundheitszentrum St.Marien Gmbh und Klinik für Strahlentherapie
Amberg, 92224, Germany
Medizinisches Versorgungszentrum Aue
Aue, 08280, Germany
Helios Kliniken Bad Saarow Klinik für Radioonkologie
Bad Saarow, 15526, Germany
HELIOS Klinikum Bad Saarow
Bad Saarow, 15526, Germany
Strahlentherapie Klinikum Bayreuth
Bayreuth, 95445, Germany
Medizinisches Versorgungs Zentrum Diagnostisch Therapeutisches Zentrum am Frankfurter Tor
Berlin, 10243, Germany
Strahlentherapie in Moabit /Praxis für Strahlentherapie
Berlin, 10559, Germany
Praxis für Radioonkologie und Strahlentherapie Berlin Südwest
Berlin, 12157, Germany
Ambulantes Gesundheitszentrum der Dr. med Maria Sternemann Charte -Universitätsmedizin Berlin
Berlin, 12200, Germany
Vivantes-Klinikum Berlin-Neukölln
Berlin, 12351, Germany
HELIOS Klinikum Berlin-Buch, Strahlentherapeutische Klinik
Berlin, 13125, Germany
Charite berlin (Virchow) Klinik für Strahlentherapie
Berlin, 13353, Germany
DRK Kliniken Berlin: Zentrum für Strahlentherapie MVZ pro patiente Westend
Berlin, 14050, Germany
MZV am HELIOS Klinikum Emil von Behring
Berlin, 14165, Germany
Gemeinschaftspraxis und Belegabteilung für Strahlentherapie
Bocholt, 46399, Germany
Ambulanz Bremen GMBH MVZ RadioOnkologie
Bremen, 28205, Germany
Zentrum für Strahlentherapie undRadioonkologie
Bremen, 28239, Germany
Krankenhaus Buchholz Abteilung für Strahlentherapie
Buchholz, 21244, Germany
Strahlentherapie Coesfeld
Coesfeld, 48653, Germany
Radiologie Strahlentherapie-Zweigpraxis vom MVZ Passau
Deggendorf, 94469, Germany
Praxis für Strahlentherapie Krankenhaus Dresden-Friedrichsstadt
Dresden, 01067, Germany
Malteser MVZ Duisburg-Süd
Duisburg, 470530, Germany
Universitätsklinikum Düsseldorf Klinik und Poliklinik für Strahlentherapie und Radioologische Onkologie
Düsseldorf, 40225, Germany
Gemeinschaftspraxis für Strahlentherapie und Radioonkologie
Elmshorn, 25337, Germany
MVZ Strahlentherapie Klinikum Esslingen GmbH
Esslingen am Neckar, 73730, Germany
Klinikum Frankfurt (Oder)Klinikum für Strahlentherapie Radioonkologie
Frankfurt (Oder), 15236, Germany
Klinik für Strahlentherapie und Onkologie
Frankfurt/M, 60590, Germany
Strahlentherapie am Klinikum Fürth
Fürth, 90766, Germany
Strahlentherapiezentrum- Escher-Lippe(STZELL) und die Katholischen Kliniken-Emscher
Gelsenkirchen, 45899, Germany
Justus-Liebig Universität Gießen Strahlentherapie
Giessen, 35392, Germany
Praxis für Strahlentherapie Goch
Goch, 47574, Germany
Brustzentrum ALB FILS Kliniken GMBH
Göppingen, 73035, Germany
Ambulanzzentrum des UKE GmbH Bereich der Strahlentherapie
Hamburg, 20246, Germany
Radiologische Ambulanz Fachärzte für Radiologie,Nuklearmedizin und Strahlentherapie
Hamburg, 22307, Germany
Strahlenzentrum Hamburg
Hamburg, 22419, Germany
GSR Hameln
Hamelin, 31785, Germany
Gemeinschaftspraxis für Strahlentherapie und Radioonkologie / Hannover/Hildesheim/Hameln
Hanover, 30161, Germany
GSR Hannover Siloa
Hanover, 30449, Germany
Dr.med Jürgen Heide Facharzt für Strahlentherapie
Harburg, 21075, Germany
Gemeinschaftspraxis für Strahlentherapie und Radioonkologie(GSR)
Hildesheim, 31134, Germany
Gemeinschaftspraxis für Strahlentherapie Hildesheim/Goslar
Hildesheim, 31135, Germany
Gemeinschaftspraxis für Strahlentherapie/Hildesheim/Goslar
Hildesheim, 31135, Germany
Strahlentherapie Hof
Hof, 95032, Germany
MVZ St. Vincent-Kliniken gAG
Karlsruhe, 76135, Germany
Praxis für Strahlentherapie am Universitätsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Universitätsklinikum Leibzig
Leipzig, 04103, Germany
Klinikum für Strahlentherapie - Klinikum Lippe
Lemgo, 32657, Germany
Klinikum Ludwigsburg Klinik für Radioonkologie
Ludwigsburg, 71640, Germany
Klinikum Lüneburg, Klinik für Strahlentherapie und Radioonkologie
Lüneburg, 21339, Germany
MVZ Prof.Dr.Uhlenbrock und Partner Strahlentherapie Lünen
Lünen, 44534, Germany
Klinik und Poliklinik für Radioonkologie und Strahlentherapie Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Praxis für Strahlentherapie Mannheim
Mannheim, 68309, Germany
Universitätsklinikum Marburg Strahlentherapie und Radioonkologie
Marburg, 35033, Germany
Brustzentrum Helios Klinikum
Meiningen, 98617, Germany
MVZ Chariete Vivantes Gmbh Strahlentherapie
Mitte, 10249, Germany
Kliniken Maria Hilf Gmbh Klinik für Strahlentherapie
Mönchengladbach, 41063, Germany
Klinikum rechts der Isar
München, 81675, Germany
Klinik für Strahlentherapie- Radioonkologie
Münster, 48149, Germany
Praxis für Strahlentherapie und Radioonkologie am Clemenshospital
Münster, 48153, Germany
Strahlentherapie Neckarsulm
Neckarsulm, 74172, Germany
Dietrich Bonhoeffer Klinikum Neubrandenburg
Neubrandenburg, 17022, Germany
Praxis für Strahlentherapie Im Städtischen Klinikum Neunkirchen
Neunkirchen, 66538, Germany
Klinik für Strahlentherapie und Radioonkologie Pius-Hospital Oldenburg
Oldenburg, 26121, Germany
Zentrum für Strahlentherapie Rheine-Osnabrück
Osnabrück, 49076, Germany
MVZ Radio-LOG Schie in Altötting
Passau, 94032, Germany
Visiorad - Bereich Strahlentherapie
Pinneberg, 25421, Germany
Klinikum für Radioonkologie Klinikum Ernst von Bergmann
Potsdam, 14467, Germany
Krankenhaus Barmherzige Brüder Regensburg Medizinisches Versorgungszentrum
Regensburg, 93049, Germany
Überörtliche Gemeinschaftspraxis/Fachärzte für Strahlentherapie
Rheine, 48431, Germany
Kreiskliniken Esslingen Paracelsus Krankenhaus Ruit
Ruit, 73760, Germany
CaritasKlinikum Saarbrücken
Saarbrücken, 66113, Germany
XCare Praxis für Strahlentherapie
Saarlouis, 66740, Germany
MVZ Leopoldina Strahlentherapie
Schweinfurt, 97422, Germany
MVZ Leopoldina
Schweinfurt, 97422, Germany
Helios kliniken Schwerin GMBH
Schwerin, 19055, Germany
Johanniter Zentren für medizinische Versorgung in der Altmark GMBH
Stendal, 39576, Germany
Johanniter Zentrum für Medizinische Versorgung
Stendal, 39576, Germany
MVZ Klinikum Straubing GMBH Strahlentherapie
Straubing, 94315, Germany
MVZ-Uniklinik Tübingen gGmbH
Stuttgart, 70176, Germany
Praxis für Strahlentherapie Trier Ehrang
Trier, 54293, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Ulm
Ulm, 89081, Germany
Klinik für Strahlentherapie und Radioonkologie Schwarzwald-Baar -Klinikum
Villingen-Schwenningen, 78052, Germany
Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
Weilheim, 82362, Germany
Medizinisches Versorgungszentrum Wolfsburg GmbH
Wolfsberg, 38440, Germany
Universitätsklinikum Würzburg Klinik und Poliklinik für Strahlentherapie
Würzburg, 97080, Germany
Heinrich-Braun-Klinikum Zwickau
Zwickau, 08060, Germany
Related Publications (1)
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.
PMID: 33320286BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jürgen Dunst, MD
University Medical Center Schleswig-Holstein (UKSH)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Juergen Dunst, Prof.
Study Record Dates
First Submitted
June 4, 2015
First Posted
June 18, 2015
Study Start
June 16, 2015
Primary Completion
January 8, 2019
Study Completion (Estimated)
March 31, 2028
Last Updated
March 21, 2024
Record last verified: 2024-03