OLIGOMA
Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer
Rekrutierend
NCT-Nummer:
NCT04495309
Studienbeginn:
März 2021
Letztes Update:
28.04.2021
Wirkstoff:
-
Indikation (Clinical Trials):
Breast Neoplasms
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
University Hospital Schleswig-Holstein
Collaborator:
-
Studienleiter
Jürgen Dunst, Professor Study DirectorUniversity Hospital Schleswig-Holstein
Kontakt
Kathrin Dellas, Professor Kontakt: Phone: 0431/500/26570 E-Mail: Kathrin.Dellas@uksh.de» Kontaktdaten anzeigen
Studienlocations (3 von 14)
Mannheim Baden-Württemberg Germany Weilheim Bayern Frankfurt (Oder) Brandenburg Marburg Hessen Hameln Niedersachsen Hildesheim Wolfsburg Bocholt Nordrhein-Westfalen Gelsenkirchen Saarlouis Saarland Dresden Sachsen Zwickau Kiel Schleswig-Holstein Stendal Sachsen-Anhalt
Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie 68167 Mannheim (Baden-Württemberg) GermanyRekrutierend » Google-Maps Ansprechpartner: Elena Sperk, MD Phone: 0049/621 383 4241 E-Mail: elena.sperk@umm.de» Ansprechpartner anzeigen Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim 82362 Weilheim (Bayern) GermanyRekrutierend » Google-Maps Ansprechpartner: Monika Panzer, MD Phone: 0049/88192452340 E-Mail: mpa@strahlentherapie-weilheim.deMichaela Riepl, MD Phone: 0049/88192452340 E-Mail: mrp@strahlentherapie-weilheim.de» Ansprechpartner anzeigen Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie 15236 Frankfurt (Oder) (Brandenburg) GermanyRekrutierend » Google-Maps Ansprechpartner: Reinhard E. Wurm, MD Phone: 0049/335 548 4721 E-Mail: reinhard.wurm@klinikumffo.de» Ansprechpartner anzeigen Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie 35033 Marburg (Hessen) GermanyRekrutierend » Google-Maps Ansprechpartner: Hilke Vorwerk, Prof. Phone: 0049/6421 58 66270 E-Mail: hilke.vorwerk@med.uni-marburg.de» Ansprechpartner anzeigen GSR Hameln im Sana Klinikum Hameln-Pyrmont 31785 Hameln (Niedersachsen) GermanyRekrutierend » Google-Maps Ansprechpartner: Stefan Janssen, MD Phone: 0049/5151 9626320 E-Mail: stefan.janssen@strahlentherapie.de» Ansprechpartner anzeigen Gemeinschaftspraxis für Strahlentherapie 31135 Hildesheim (Niedersachsen) GermanyRekrutierend » Google-Maps Ansprechpartner: Susann Popella, MD Phone: 0049/5121 8942 913 E-Mail: spopella@strahlentherapie-hildesheim.de» Ansprechpartner anzeigen MVZ WOB GmbH Strahlentherapie 38440 Wolfsburg (Niedersachsen) GermanyRekrutierend » Google-Maps Ansprechpartner: Marcel Ott, MD Phone: 0049/5361 803850 E-Mail: Marcel.Ott@Klinikum.Wolfsburg.de» Ansprechpartner anzeigen Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital 46397 Bocholt (Nordrhein-Westfalen) GermanyRekrutierend » Google-Maps Ansprechpartner: Eckhard Horst, MD Phone: 0049/2871 246540 E-Mail: horst@strahlentherapie-bocholt.de» Ansprechpartner anzeigen Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie 45879 Gelsenkirchen (Nordrhein-Westfalen) GermanyRekrutierend » Google-Maps Ansprechpartner: Rodrigo Hepp, MD Phone: 0049/209 160 53001 E-Mail: heppdelosrios@evk-ge.de» Ansprechpartner anzeigen Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus 66740 Saarlouis (Saarland) GermanyRekrutierend » Google-Maps Ansprechpartner: Sevda Toperim Phone: 0049/6831 161229 E-Mail: sevda.toperim@x-care.de» Ansprechpartner anzeigen Städtisches Klinikum Dresden, Strahlentherapie 01067 Dresden (Sachsen) GermanyRekrutierend » Google-Maps Ansprechpartner: Andreas Schreiber, MD Phone: 0049/3514803500 E-Mail: Andreas.Schreiber@klinikum-dresden.deJörg Zimmer, MD Phone: 0049/3514803501 E-Mail: Zimmer-Jo@khdf.de» Ansprechpartner anzeigen Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie 08060 Zwickau (Sachsen) GermanyRekrutierend » Google-Maps Ansprechpartner: Alexander Boicev, MD Phone: 0049/375512802 E-Mail: alexander.boicev@hbk-zwickau.de» Ansprechpartner anzeigen Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel 24105 Kiel (Schleswig-Holstein) GermanyRekrutierend » Google-Maps Ansprechpartner: Juergen Dunst, Prof. Phone: 0049/431/50026500 E-Mail: Juergen.Dunst@uksh.deKathrin Dellas, Prof. Phone: 0049/431/50026570 E-Mail: Kathrin.Dellas@uksh.de» Ansprechpartner anzeigen Johanniter-Krankenhaus Genthin-Stendal 39576 Stendal (Sachsen-Anhalt) GermanyRekrutierend » Google-Maps Ansprechpartner: Evelyn Weinstrauch, MD Phone: 0049/3931 661504 E-Mail: evelyn.weinstrauch@sdl.johanniter-kliniken.deSachsen-Anhalt » Ansprechpartner anzeigen Alle anzeigen
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.
Inclusion Criteria: - Metastasized breast cancer - up to 5 clinically manifest (new, progressive, persistent) metastases (a lymph node metastasis and a circumscribed local recurrence are each considered as one metastasis, i.e. also locoregional recurrent breast carcinomas with additional hematogenic metastasis possible) - maximum of 3 cerebral metastases known - indication for palliative drug therapy (endocrine therapy and/or chemotherapy and/or treatment with other substances) given according to guidelines (1st-line or further therapy lines, a special regime is not specified) - Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 - local radiation of all metastases possible - presentation of a written declaration of consent - patient ≥ 18 yearsExclusion Criteria: - Previous radiotherapy, if this interferes with treatment within the scope of the study - symptomatic metastases requiring local therapy of all metastases (e.g. pain radiation), a radiation indication (or other local therapy) for individual metastases is not a criterion for exclusion - known central nervous system (CNS) metastasis without extracerebral metastasis (in these cases, immediate local therapy is mandatory) - more than three known CNS metastases (no indication for purely local therapy of only the metastases, primary whole brain radiation is indicated) - multifocal metastasis in one organ with impossibility to comply with the dose constraints for this organ (e.g., no indication for local therapy of only the metastases, primary whole brain radiation is indicated) (e.g. in the liver) - exclusively regional lymph node metastasis without haematogenic metastases (in these cases local therapy is clearly indicated according to guidelines) - relevant comorbidity, if this results in restrictions for further therapy - Incapacity to contract or lack of informed consent - Pregnancy and lactation
Primary outcome: 1. First co-primary outcome measure is progression-free survival (PFS) (Time Frame - at least 12 months after randomization):Co-primary progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST) 2. Second co-primary outcome measure is quality of life (Time Frame - 12 weeks after randomization):Co-primary quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer patients with 30 items (QLQ-C30) sum score Secondary outcome: 1. Feasibility (per-protocol within intention-to-treat) (Time Frame - 12 weeks):Proportion of participants treated per protocol 2. Overall survival (Time Frame - at least 1, up to 5 years):Time between randomization and death 3. Toxicity (number and degree of reported toxicities in both treatment arms) (Time Frame - 0 to 5 years):Proportion of participants with degree of toxicities as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) and by Radiation Treatment Oncology Group (RTOG) by point in time of follow-up with higher degree indicating higher intensity 4. Neoplasia-specific quality of life (Time Frame - quarterly up to 5 years):Research and Treatment of Cancer (EORTC) Quality of Life Questionaire for Cancer patients with 30 items (QLQ-C30) with different scales 5. Breast cancer-specific quality of life (Time Frame - quarterly up to 5 years):Research and Treatment of Cancer (EORTC) Quality of Life Questionaire for breast cancer patients with 23 items (QLQ-BR23) on 4-point Likert scales with different directions 6. Patient satisfaction (Time Frame - 12 weeks):Research and Treatment of Cancer (EORTC) Patient satisfaction questionnaire for cancer patients with 33 items (PATSAT-C33) on 5-point Likert scale with higher scores indicating greater satisfaction 7. Frequency of adverse events (Time Frame - 0 to 5 years):Number of patients with adverse and serious adverse events
No Intervention: StandardStandard of care, i. e. no local radiotherapy in addition to standard systemic therapy (exception: palliative local treatment of symptomatic lesions where indicated) Experimental: ExperimentalStandard of care (standard systemic therapy) + study intervention
Metastases-directed Radiotherapy:Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions
Quelle: ClinicalTrials.gov
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