🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT02474641
Active, not recruiting Not applicable

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

NCT02474641 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2015-06-16
Last updated
2024-03-21

Condition(s) studied

Early-Stage Breast Carcinoma

Investigational drug(s) / intervention(s)

Standard RadiationHypofractionation with SIB

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (88)

FacilityCityRegionStatus
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

+ 48 more sites — see the full list on the official registry below.

More University Hospital Schleswig-Holstein trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02474641 on ClinicalTrials.gov ↗ ← All trials in Germany