Clinical trial NCT02474641: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer
Official title: Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Early-Stage Breast Carcinoma
Keywords: Breast cancer
Hypofractionation with SIB
Non-inferiority
adjuvant radiotherapy with simultaneous integrated boost
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: University of Luebeck
First posted: 2015-06-18
Enrollment: 2324
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival
timeFrame: 3 to 6 years
Secondary outcomes:
measure: Time to occurence of local recurrence
timeFrame: 3 to 6 years
measure: Overall survival
timeFrame: 3 to 6 years
measure: Safety and side effects (Number of Patients with Adverse Events)
timeFrame: 3 to 6 years
measure: Acute and chronic toxicity (NCI-CTCAE)
timeFrame: 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
measure: Cosmetic results (NCI-CTCAE)
timeFrame: 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
Other outcomes:
Locations:
city: Amberg
country: Germany
facility: Gesundheitszentrum St.Marien Gmbh und Klinik für Strahlentherapie
city: Aue
country: Germany
facility: Medizinisches Versorgungszentrum Aue
city: Bad Saarow
country: Germany
facility: Helios Kliniken Bad Saarow Klinik für Radioonkologie
city: Bad Saarow
country: Germany
facility: HELIOS Klinikum Bad Saarow
city: Bayreuth
country: Germany
facility: Strahlentherapie Klinikum Bayreuth
city: Berlin ( Mitte)
country: Germany
facility: MVZ Chariete Vivantes Gmbh Strahlentherapie
city: Berlin
country: Germany
facility: Medizinisches Versorgungs Zentrum Diagnostisch Therapeutisches Zentrum am Frankfurter Tor
city: Berlin
country: Germany
facility: Strahlentherapie in Moabit /Praxis für Strahlentherapie
city: Berlin
country: Germany
facility: Praxis für Radioonkologie und Strahlentherapie Berlin Südwest
city: Berlin
country: Germany
facility: Ambulantes Gesundheitszentrum der Dr. med Maria Sternemann Charte -Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Vivantes-Klinikum Berlin-Neukölln
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch, Strahlentherapeutische Klinik
city: Berlin
country: Germany
facility: Charite berlin (Virchow) Klinik für Strahlentherapie
city: Berlin
country: Germany
facility: DRK Kliniken Berlin: Zentrum für Strahlentherapie MVZ pro patiente Westend
city: Berlin
country: Germany
facility: MZV am HELIOS Klinikum Emil von Behring
city: Bocholt
country: Germany
facility: Gemeinschaftspraxis und Belegabteilung für Strahlentherapie
city: Bremen
country: Germany
facility: Ambulanz Bremen GMBH MVZ RadioOnkologie
city: Bremen
country: Germany
facility: Zentrum für Strahlentherapie undRadioonkologie
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz Abteilung für Strahlentherapie
city: Coesfeld
country: Germany
facility: Strahlentherapie Coesfeld
city: Deggendorf
country: Germany
facility: Radiologie Strahlentherapie-Zweigpraxis vom MVZ Passau
city: Dresden
country: Germany
facility: Praxis für Strahlentherapie Krankenhaus Dresden-Friedrichsstadt
city: Duisburg
country: Germany
facility: Malteser MVZ Duisburg-Süd
city: Dusseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf Klinik und Poliklinik für Strahlentherapie und Radioologische Onkologie
city: Elmshorn
country: Germany
facility: Gemeinschaftspraxis für Strahlentherapie und Radioonkologie
city: Esslingen
country: Germany
facility: MVZ Strahlentherapie Klinikum Esslingen GmbH
city: Frankfurt/M
country: Germany
facility: Klinik für Strahlentherapie und Onkologie
city: Frankfurt/Oder
country: Germany
facility: Klinikum Frankfurt (Oder)Klinikum für Strahlentherapie Radioonkologie
city: Fürth
country: Germany
facility: Strahlentherapie am Klinikum Fürth
city: Gelsenkirchen
country: Germany
facility: Strahlentherapiezentrum- Escher-Lippe(STZELL) und die Katholischen Kliniken-Emscher
city: Gießen
country: Germany
facility: Justus-Liebig Universität Gießen Strahlentherapie
city: Goch
country: Germany
facility: Praxis für Strahlentherapie Goch
city: Göppingen
country: Germany
facility: Brustzentrum ALB FILS Kliniken GMBH
city: Hamburg Harburg
country: Germany
facility: Dr.med Jürgen Heide Facharzt für Strahlentherapie
city: Hamburg
country: Germany
facility: Ambulanzzentrum des UKE GmbH Bereich der Strahlentherapie
city: Hamburg
country: Germany
facility: Radiologische Ambulanz Fachärzte für Radiologie,Nuklearmedizin und Strahlentherapie
city: Hamburg
country: Germany
facility: Strahlenzentrum Hamburg
city: Hameln
country: Germany
facility: GSR Hameln
city: Hannover
country: Germany
facility: Gemeinschaftspraxis für Strahlentherapie und Radioonkologie / Hannover/Hildesheim/Hameln
city: Hannover
country: Germany
facility: GSR Hannover Siloa
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis für Strahlentherapie und Radioonkologie(GSR)
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis für Strahlentherapie Hildesheim/Goslar
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis für Strahlentherapie/Hildesheim/Goslar
city: Hof
country: Germany
facility: Strahlentherapie Hof
city: Karlsruhe
country: Germany
facility: MVZ St. Vincent-Kliniken gAG
city: Kiel
country: Germany
facility: Praxis für Strahlentherapie am Universitätsklinikum Schleswig-Holstein
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: Universitätsklinikum Leibzig
city: Lemgo
country: Germany
facility: Klinikum für Strahlentherapie - Klinikum Lippe
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg Klinik für Radioonkologie
city: Lüneburg
country: Germany
facility: Klinikum Lüneburg, Klinik für Strahlentherapie und Radioonkologie
city: Lünen
country: Germany
facility: MVZ Prof.Dr.Uhlenbrock und Partner Strahlentherapie Lünen
city: Mainz
country: Germany
facility: Klinik und Poliklinik für Radioonkologie und Strahlentherapie Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Praxis für Strahlentherapie Mannheim
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg Strahlentherapie und Radioonkologie
city: Meiningen
country: Germany
facility: Brustzentrum Helios Klinikum
city: Monchengladbach
country: Germany
facility: Kliniken Maria Hilf Gmbh Klinik für Strahlentherapie
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar
city: Münster
country: Germany
facility: Klinik für Strahlentherapie- Radioonkologie
city: Münster
country: Germany
facility: Praxis für Strahlentherapie und Radioonkologie am Clemenshospital
city: Neckarsulm
country: Germany
facility: Strahlentherapie Neckarsulm
city: Neubrandenburg
country: Germany
facility: Dietrich Bonhoeffer Klinikum Neubrandenburg
city: Neunkirchen
country: Germany
facility: Praxis für Strahlentherapie Im Städtischen Klinikum Neunkirchen
city: Oldenburg
country: Germany
facility: Klinik für Strahlentherapie und Radioonkologie Pius-Hospital Oldenburg
city: Osnabrück
country: Germany
facility: Zentrum für Strahlentherapie Rheine-Osnabrück
city: Passau
country: Germany
facility: MVZ Radio-LOG Schie in Altötting
city: Pinneberg
country: Germany
facility: Visiorad - Bereich Strahlentherapie
city: Potsdam
country: Germany
facility: Klinikum für Radioonkologie Klinikum Ernst von Bergmann
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg Medizinisches Versorgungszentrum
city: Rheine
country: Germany
facility: Überörtliche Gemeinschaftspraxis/Fachärzte für Strahlentherapie
city: Ruit
country: Germany
facility: Kreiskliniken Esslingen Paracelsus Krankenhaus Ruit
city: Saarbrucken
country: Germany
facility: CaritasKlinikum Saarbrücken
city: Saarlouis
country: Germany
facility: XCare Praxis für Strahlentherapie
city: Schweinfurt
country: Germany
facility: MVZ Leopoldina Strahlentherapie
city: Schweinfurt
country: Germany
facility: MVZ Leopoldina
city: Schwerin
country: Germany
facility: Helios kliniken Schwerin GMBH
city: Stendal
country: Germany
facility: Johanniter Zentren für medizinische Versorgung in der Altmark GMBH
city: Stendal
country: Germany
facility: Johanniter Zentrum für Medizinische Versorgung
city: Straubing
country: Germany
facility: MVZ Klinikum Straubing GMBH Strahlentherapie
city: Stuttgart
country: Germany
facility: MVZ-Uniklinik Tübingen gGmbH
city: Trier
country: Germany
facility: Praxis für Strahlentherapie Trier Ehrang
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Ulm
city: Villingen-Schwenningen
country: Germany
facility: Klinik für Strahlentherapie und Radioonkologie Schwarzwald-Baar -Klinikum
city: Weilheim
country: Germany
facility: Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
city: Wolfsberg
country: Germany
facility: Medizinisches Versorgungszentrum Wolfsburg GmbH
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg Klinik und Poliklinik für Strahlentherapie
city: Zwickau
country: Germany
facility: Heinrich-Braun-Klinikum Zwickau
Study officials:
affiliation: University Medical Center Schleswig-Holstein (UKSH)
name: Jürgen Dunst, MD
role: STUDY_CHAIR
References:
citation: 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.