Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Radiation: Metastases-directed Radiotherapy
- Registration Number
- NCT04495309
- Lead Sponsor
- University Hospital Schleswig-Holstein
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 564
- 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 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Metastases-directed Radiotherapy Standard of care (standard systemic therapy) + study intervention
- Primary Outcome Measures
Name Time Method First co-primary outcome measure is progression-free survival (PFS) at least 12 months after randomization Co-primary progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST)
Second co-primary outcome measure is quality of life 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 Measures
Name Time Method Breast cancer-specific quality of life 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
Feasibility (per-protocol within intention-to-treat) 12 weeks Proportion of participants treated per protocol
Overall survival at least 1, up to 5 years Time between randomization and death
Toxicity (number and degree of reported toxicities in both treatment arms) 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
Neoplasia-specific quality of life 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
Patient satisfaction 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
Frequency of adverse events 0 to 5 years Number of patients with adverse and serious adverse events
Trial Locations
- Locations (14)
Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus
🇩🇪Saarlouis, Saarland, Germany
Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie
🇩🇪Frankfurt (Oder), Brandenburg, Germany
Gemeinschaftspraxis für Strahlentherapie
🇩🇪Hildesheim, Niedersachsen, Germany
MVZ WOB GmbH Strahlentherapie
🇩🇪Wolfsburg, Niedersachsen, Germany
Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Schleswig-Holstein, Germany
GSR Hameln im Sana Klinikum Hameln-Pyrmont
🇩🇪Hameln, Niedersachsen, Germany
Johanniter-Krankenhaus Genthin-Stendal
🇩🇪Stendal, Germany
Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie
🇩🇪Zwickau, Sachsen, Germany
Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie
🇩🇪Mannheim, Baden-Württemberg, Germany
Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
🇩🇪Weilheim, Bayern, Germany
Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie
🇩🇪Marburg, Hessen, Germany
Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital
🇩🇪Bocholt, Nordrhein-Westfalen, Germany
Städtisches Klinikum Dresden, Strahlentherapie
🇩🇪Dresden, Sachsen, Germany
Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie
🇩🇪Gelsenkirchen, Nordrhein-Westfalen, Germany