Spots Global Cancer Trial Database for Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer
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Trial Identification
Brief Title: Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer
Official Title: Effectiveness and Tolerability of Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer: A Randomized Controlled Multinational and Multicenter Clinical Trial
Study ID: NCT04495309
Conditions
Interventions
Study Description
Brief Summary: The prognosis for patients with metastatic breast cancer has improved continuously. Systemic therapies alone are not able to cure the disease permanently. Investigators initiated this randomized controlled multinational and multicenter clinical trial to analyse the impact of a local metastases-directed radiotherapy in addition to standard systemic therapy in patients with oligometastatic breast cancer on progression-free survival and quality of life.
Detailed Description: Preferably ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions. Larger lesions or lesions with critical normal tissue involvement should be treated with three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) in moderate hypofractionated radiotherapy (depending on the size and location of the target volume and the decision of the radiooncologist). For critical organs in the target volume, standard fractionated radiotherapy can be used.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie, Mannheim, Baden-Württemberg, Germany
Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim, Weilheim, Bayern, Germany
Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie, Frankfurt (Oder), Brandenburg, Germany
Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie, Marburg, Hessen, Germany
GSR Hameln im Sana Klinikum Hameln-Pyrmont, Hameln, Niedersachsen, Germany
Gemeinschaftspraxis für Strahlentherapie, Hildesheim, Niedersachsen, Germany
MVZ WOB GmbH Strahlentherapie, Wolfsburg, Niedersachsen, Germany
Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital, Bocholt, Nordrhein-Westfalen, Germany
Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie, Gelsenkirchen, Nordrhein-Westfalen, Germany
Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus, Saarlouis, Saarland, Germany
Städtisches Klinikum Dresden, Strahlentherapie, Dresden, Sachsen, Germany
Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie, Zwickau, Sachsen, Germany
Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Schleswig-Holstein, Germany
Johanniter-Krankenhaus Genthin-Stendal, Stendal, , Germany
Contact Details
Name: Jürgen Dunst, Professor
Affiliation: University Hospital Schleswig-Holstein
Role: STUDY_DIRECTOR
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