Klinik für Strahlentherapie und Radioonkologie Stuttgart 70174 Stuttgart (Baden-Württemberg) GermanyRekrutierend» Google-Maps Ansprechpartner: Marc Münter, Prof. Dr. Phone: 0711 278-34201 E-Mail: k.stahl@klinikum-stuttgart.de» Ansprechpartner anzeigenKlinik für Strahlentherapie Bayreuth 95445 Bayreuth (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Ludwig Keilholz, Prof. Dr. Phone: 0921 400-6802» Ansprechpartner anzeigenStrahlentherapie Coburg 96450 Coburg (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Gerhard Grabenbauer, Prof. Dr. Phone: 09561 2491-0 E-Mail: strahlentherapie@diacura.de» Ansprechpartner anzeigen
Radio-Log Strahlentherapie Hof 95032 Hof (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Christoph Straube, PD Dr. Phone: 09281-140369 0 E-Mail: strahlentherapie-hof@radio-log.de» Ansprechpartner anzeigenStrahlentherapie Süd Kempten 87439 Kempten (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Sterzing, Prof. Dr. Phone: +49(0)831 9607940 E-Mail: info@strahlentherapie-kempten.de» Ansprechpartner anzeigenKlinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM) 81675 München (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Denise Bernhardt, PD Dr. Phone: +49 89 4140 4501» Ansprechpartner anzeigenKlinik und Poliklinik für Strahlentherapie Regensburg 93053 Regensburg (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Oliver Kölbl, Prof. Dr.» Ansprechpartner anzeigenKlinik für Strahlentherapie und Radioonkologie 53127 Bonn (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Christopher Schmeel, PD Dr. Phone: +49 228 287-10354 E-Mail: Anmeldung.Strahlentherapie@ukbonn.de» Ansprechpartner anzeigenUniversitätsklinik und Poliklinik für Strahlentherapie Halle 06120 Halle (Sachsen-Anhalt) GermanyRekrutierend» Google-Maps Ansprechpartner: Christian Dietzel, Dr. med. Phone: 0345 557 4310 E-Mail: Strahlentherapie@uk-halle.de» Ansprechpartner anzeigenKlink und Praxis für Radioonkologie Chemnitz 09113 Chemnitz (Sachsen) GermanyRekrutierend» Google-Maps Ansprechpartner: Gunther Klautke, PD Dr. med.» Ansprechpartner anzeigenKlinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena 07745 Jena (Thüringen) GermanyRekrutierend» Google-Maps Ansprechpartner: Andrea Wittig, Prof. Dr. Phone: 03641/9-328401 E-Mail: strahlentherapie@med.uni-jena.de» Ansprechpartner anzeigenKlinik für Radioonkologie und Strahlentherapie Charité Berlin 13353 Berlin (Berlin) GermanyRekrutierend» Google-Maps Ansprechpartner: Felix Ehret, Dr. med. Phone: +49 30 450 527 152 E-Mail: melita.dimitrijevic@charite.de» Ansprechpartner anzeigenErlangen, Universitätsklinikum Strahlenklinik 91054 Erlangen (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Rainer Fietkau, Prof. Phone: +499131-85-33405 E-Mail: rainer.fietkau@uk-erlangen.de» Ansprechpartner anzeigen
1. Time to local progression - TTLP (Time Frame - 12 months): Local progression will be defined according to the RANO-BM criteria by an increase of at least 20% in the longest diameter of the metastasis relative to nadir or baseline. In addition to the relative increase of 20% the lesion must increase by an absolute value of 5 mm or more.
TTLP is defined as the time from randomization until the detection of progression as per the RANO-BM criteria. Patients will be censored if they have no signs of local progression at the time of last tumor monitoring during follow-up or at the onset of one of the following competing risk events not associated with local progression: death, lost to follow up, unauthorized non-protocol treatment of the target lesion.
Confirmatory analysis of the primary endpoint variable will be performed using a p-value of p≤0.05 as the global significance level.
Secondary outcome:
1. CNS toxicity according to CTCAE v5.0 (Time Frame - 12 months): CNS toxicity according to CTCAE v5.0
2. Time to local progression (Volumetric RANO-BM criteria) (Time Frame - 12 months): Based on the RANO-BM criteria, progression is defined as an increase in volume of 72.8% or more (corresponds to a 20% increase in diameter for a perfect sphere).
3. Quality of Life according to EORTC QLQ-C30 (Time Frame - Change from baseline to 3, 6, 12 and 24 months): Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ C30
4. Local-Progression-Free Survival (Time Frame - 12 months): Local-Progression-Free Survival is defined like TTLP except that death not associated with local progression will not be censored but assessed as a separate event
6. Quality of Life according to EORTC QLQ-BN20 (Time Frame - Change from baseline to 3, 6, 12 and 24 months): Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ BN20
Other: Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and no margin as defined by the RTOG 9005
Other: Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin