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Early-Stage Breast CarcinomaHYPOSIBNCT02474641

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

A study testing Standard Radiation and Hypofractionation with SIB in people with Early-Stage Breast Carcinoma, run by University Hospital Schleswig-Holstein at 88 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Early-Stage Breast Carcinoma
What is being tested?
Standard Radiation and Hypofractionation with SIB
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,324 participants
Where
88 sitesGermany
Study dates
16 Jun 2015to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Written informed consent
  • Compliance regarding treatment appointments and toxicity
  • Linguistic and cognitive ability to understand the questionnaires

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

88 sites in 1 country.

88 sites in 1 country

Germany88 sites

  • Gesundheitszentrum St.Marien Gmbh und Klinik für Strahlentherapie

    Amberg, 92224

  • Medizinisches Versorgungszentrum Aue

    Aue, 08280

  • Helios Kliniken Bad Saarow Klinik für Radioonkologie

    Bad Saarow, 15526

  • HELIOS Klinikum Bad Saarow

    Bad Saarow, 15526

  • Strahlentherapie Klinikum Bayreuth

    Bayreuth, 95445

  • Medizinisches Versorgungs Zentrum Diagnostisch Therapeutisches Zentrum am Frankfurter Tor

    Berlin, 10243

  • Strahlentherapie in Moabit /Praxis für Strahlentherapie

    Berlin, 10559

  • Praxis für Radioonkologie und Strahlentherapie Berlin Südwest

    Berlin, 12157

  • Ambulantes Gesundheitszentrum der Dr. med Maria Sternemann Charte -Universitätsmedizin Berlin

    Berlin, 12200

  • Vivantes-Klinikum Berlin-Neukölln

    Berlin, 12351

  • HELIOS Klinikum Berlin-Buch, Strahlentherapeutische Klinik

    Berlin, 13125

  • Charite berlin (Virchow) Klinik für Strahlentherapie

    Berlin, 13353

  • DRK Kliniken Berlin: Zentrum für Strahlentherapie MVZ pro patiente Westend

    Berlin, 14050

  • MZV am HELIOS Klinikum Emil von Behring

    Berlin, 14165

  • Gemeinschaftspraxis und Belegabteilung für Strahlentherapie

    Bocholt, 46399

  • Ambulanz Bremen GMBH MVZ RadioOnkologie

    Bremen, 28205

  • Zentrum für Strahlentherapie undRadioonkologie

    Bremen, 28239

  • Krankenhaus Buchholz Abteilung für Strahlentherapie

    Buchholz, 21244

  • Strahlentherapie Coesfeld

    Coesfeld, 48653

  • Radiologie Strahlentherapie-Zweigpraxis vom MVZ Passau

    Deggendorf, 94469

  • Praxis für Strahlentherapie Krankenhaus Dresden-Friedrichsstadt

    Dresden, 01067

  • Malteser MVZ Duisburg-Süd

    Duisburg, 470530

  • Universitätsklinikum Düsseldorf Klinik und Poliklinik für Strahlentherapie und Radioologische Onkologie

    Düsseldorf, 40225

  • Gemeinschaftspraxis für Strahlentherapie und Radioonkologie

    Elmshorn, 25337

  • MVZ Strahlentherapie Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

  • Klinikum Frankfurt (Oder)Klinikum für Strahlentherapie Radioonkologie

    Frankfurt (Oder), 15236

  • Klinik für Strahlentherapie und Onkologie

    Frankfurt/M, 60590

  • Strahlentherapie am Klinikum Fürth

    Fürth, 90766

  • Strahlentherapiezentrum- Escher-Lippe(STZELL) und die Katholischen Kliniken-Emscher

    Gelsenkirchen, 45899

  • Justus-Liebig Universität Gießen Strahlentherapie

    Giessen, 35392

  • Praxis für Strahlentherapie Goch

    Goch, 47574

  • Brustzentrum ALB FILS Kliniken GMBH

    Göppingen, 73035

  • Ambulanzzentrum des UKE GmbH Bereich der Strahlentherapie

    Hamburg, 20246

  • Radiologische Ambulanz Fachärzte für Radiologie,Nuklearmedizin und Strahlentherapie

    Hamburg, 22307

  • Strahlenzentrum Hamburg

    Hamburg, 22419

  • GSR Hameln

    Hamelin, 31785

  • Gemeinschaftspraxis für Strahlentherapie und Radioonkologie / Hannover/Hildesheim/Hameln

    Hanover, 30161

  • GSR Hannover Siloa

    Hanover, 30449

  • Dr.med Jürgen Heide Facharzt für Strahlentherapie

    Harburg, 21075

  • Gemeinschaftspraxis für Strahlentherapie und Radioonkologie(GSR)

    Hildesheim, 31134

  • Gemeinschaftspraxis für Strahlentherapie Hildesheim/Goslar

    Hildesheim, 31135

  • Gemeinschaftspraxis für Strahlentherapie/Hildesheim/Goslar

    Hildesheim, 31135

  • Strahlentherapie Hof

    Hof, 95032

  • MVZ St. Vincent-Kliniken gAG

    Karlsruhe, 76135

  • Praxis für Strahlentherapie am Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitätsklinikum Leibzig

    Leipzig, 04103

  • Klinikum für Strahlentherapie - Klinikum Lippe

    Lemgo, 32657

  • Klinikum Ludwigsburg Klinik für Radioonkologie

    Ludwigsburg, 71640

  • Klinikum Lüneburg, Klinik für Strahlentherapie und Radioonkologie

    Lüneburg, 21339

  • MVZ Prof.Dr.Uhlenbrock und Partner Strahlentherapie Lünen

    Lünen, 44534

  • Klinik und Poliklinik für Radioonkologie und Strahlentherapie Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Praxis für Strahlentherapie Mannheim

    Mannheim, 68309

  • Universitätsklinikum Marburg Strahlentherapie und Radioonkologie

    Marburg, 35033

  • Brustzentrum Helios Klinikum

    Meiningen, 98617

  • MVZ Chariete Vivantes Gmbh Strahlentherapie

    Mitte, 10249

  • Kliniken Maria Hilf Gmbh Klinik für Strahlentherapie

    Mönchengladbach, 41063

  • Klinikum rechts der Isar

    München, 81675

  • Klinik für Strahlentherapie- Radioonkologie

    Münster, 48149

  • Praxis für Strahlentherapie und Radioonkologie am Clemenshospital

    Münster, 48153

  • Strahlentherapie Neckarsulm

    Neckarsulm, 74172

  • Dietrich Bonhoeffer Klinikum Neubrandenburg

    Neubrandenburg, 17022

  • Praxis für Strahlentherapie Im Städtischen Klinikum Neunkirchen

    Neunkirchen, 66538

  • Klinik für Strahlentherapie und Radioonkologie Pius-Hospital Oldenburg

    Oldenburg, 26121

  • Zentrum für Strahlentherapie Rheine-Osnabrück

    Osnabrück, 49076

  • MVZ Radio-LOG Schie in Altötting

    Passau, 94032

  • Visiorad - Bereich Strahlentherapie

    Pinneberg, 25421

  • Klinikum für Radioonkologie Klinikum Ernst von Bergmann

    Potsdam, 14467

  • Krankenhaus Barmherzige Brüder Regensburg Medizinisches Versorgungszentrum

    Regensburg, 93049

  • Überörtliche Gemeinschaftspraxis/Fachärzte für Strahlentherapie

    Rheine, 48431

  • Kreiskliniken Esslingen Paracelsus Krankenhaus Ruit

    Ruit, 73760

  • CaritasKlinikum Saarbrücken

    Saarbrücken, 66113

  • XCare Praxis für Strahlentherapie

    Saarlouis, 66740

  • MVZ Leopoldina Strahlentherapie

    Schweinfurt, 97422

  • MVZ Leopoldina

    Schweinfurt, 97422

  • Helios kliniken Schwerin GMBH

    Schwerin, 19055

  • Johanniter Zentren für medizinische Versorgung in der Altmark GMBH

    Stendal, 39576

  • Johanniter Zentrum für Medizinische Versorgung

    Stendal, 39576

  • MVZ Klinikum Straubing GMBH Strahlentherapie

    Straubing, 94315

  • MVZ-Uniklinik Tübingen gGmbH

    Stuttgart, 70176

  • Praxis für Strahlentherapie Trier Ehrang

    Trier, 54293

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Ulm

    Ulm, 89081

  • Klinik für Strahlentherapie und Radioonkologie Schwarzwald-Baar -Klinikum

    Villingen-Schwenningen, 78052

  • Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim

    Weilheim, 82362

  • Medizinisches Versorgungszentrum Wolfsburg GmbH

    Wolfsberg, 38440

  • Universitätsklinikum Würzburg Klinik und Poliklinik für Strahlentherapie

    Würzburg, 97080

  • Heinrich-Braun-Klinikum Zwickau

    Zwickau, 08060

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Standard Radiation, Hypofractionation with SIB
Keywords
Breast cancer, Hypofractionation with SIB, Non-inferiority, adjuvant radiotherapy with simultaneous integrated boost
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard RadiationRadiation

    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 SIBRadiation

    Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed

Study groups in NCT02474641
Study groupRoleWhat they receive
Standard radiationActive 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
Receives: Radiation: Standard Radiation
Hypofractionation with SIBExperimentalHypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
Receives: Radiation: Hypofractionation with SIB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    any local or regional recurrence or distant metastasis or death

    Measured: 3 to 6 years

Secondary outcomes (5)

  1. Time to occurence of local recurrence

    ipsilateral in-breast recurrence

    Measured: 3 to 6 years

  2. Overall survival

    death

    Measured: 3 to 6 years

  3. Safety and side effects (Number of Patients with Adverse Events)

    Number of Patients with Adverse Events

    Measured: 3 to 6 years

  4. Acute and chronic toxicity (NCI-CTCAE)

    All dimensions of NCI-CTCAE

    Measured: 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

  5. Cosmetic results (NCI-CTCAE)

    NCI-CTCAE

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2015 (estimated)
  2. Study start16 Jun 2015
  3. Primary completion8 Jan 2019
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02474641
Sponsor's protocol ID
ARO-2013-05, ZKS-121-001
Acronym
HYPOSIB
Status last verified
Mar 2024
First submitted
4 Jun 2015
Last updated
21 Mar 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33320286

Questions about this trial

What is this clinical trial studying?

A study testing Standard Radiation and Hypofractionation with SIB in people with Early-Stage Breast Carcinoma, run by University Hospital Schleswig-Holstein at 88 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 3 to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02474641, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.

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