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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
564
Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions
Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie
Mannheim, Baden-Wurttemberg, Germany
RECRUITINGFirst co-primary outcome measure is progression-free survival (PFS)
Co-primary progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST)
Time frame: at least 12 months after randomization
Second co-primary outcome measure is quality of life
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
Time frame: 12 weeks after randomization
Feasibility (per-protocol within intention-to-treat)
Proportion of participants treated per protocol
Time frame: 12 weeks
Overall survival
Time between randomization and death
Time frame: at least 1, up to 5 years
Toxicity (number and degree of reported toxicities in both treatment arms)
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
Time frame: 0 to 5 years
Neoplasia-specific quality of life
Research and Treatment of Cancer (EORTC) Quality of Life Questionaire for Cancer patients with 30 items (QLQ-C30) with different scales
Time frame: quarterly up to 5 years
Breast cancer-specific quality of life
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
Weilheim, Bavaria, Germany
RECRUITINGKlinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie
Frankfurt (Oder), Brandenburg, Germany
RECRUITINGUniversitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie
Marburg, Hesse, Germany
RECRUITINGGSR Hameln im Sana Klinikum Hameln-Pyrmont
Hamelin, Lower Saxony, Germany
RECRUITINGGemeinschaftspraxis für Strahlentherapie
Hildesheim, Lower Saxony, Germany
RECRUITINGMVZ WOB GmbH Strahlentherapie
Wolfsburg, Lower Saxony, Germany
RECRUITINGStrahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital
Bocholt, North Rhine-Westphalia, Germany
RECRUITINGEvangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie
Gelsenkirchen, North Rhine-Westphalia, Germany
RECRUITINGXcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus
Saarlouis, Saarland, Germany
RECRUITING...and 4 more locations
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
Time frame: quarterly up to 5 years
Patient satisfaction
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
Time frame: 12 weeks
Frequency of adverse events
Number of patients with adverse and serious adverse events
Time frame: 0 to 5 years