Clinical trial NCT04495309: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: Oligometastatic Breast Cancer
Radiotherapy
Progression-free survival (PFS)
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 564
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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 years

Exclusion 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 outcomes:
measure: First co-primary outcome measure is progression-free survival (PFS)
timeFrame: at least 12 months after randomization
measure: Second co-primary outcome measure is quality of life
timeFrame: 12 weeks after randomization
Secondary outcomes:
measure: Feasibility (per-protocol within intention-to-treat)
timeFrame: 12 weeks
measure: Overall survival
timeFrame: at least 1, up to 5 years
measure: Toxicity (number and degree of reported toxicities in both treatment arms)
timeFrame: 0 to 5 years
measure: Neoplasia-specific quality of life
timeFrame: quarterly up to 5 years
measure: Breast cancer-specific quality of life
timeFrame: quarterly up to 5 years
measure: Patient satisfaction
timeFrame: 12 weeks
measure: Frequency of adverse events
timeFrame: 0 to 5 years
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie
state: Baden-Württemberg
city: Weilheim
country: Germany
facility: Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
state: Bayern
city: Frankfurt (Oder)
country: Germany
facility: Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie
state: Brandenburg
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie
state: Hessen
city: Hameln
country: Germany
facility: GSR Hameln im Sana Klinikum Hameln-Pyrmont
state: Niedersachsen
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis für Strahlentherapie
state: Niedersachsen
city: Wolfsburg
country: Germany
facility: MVZ WOB GmbH Strahlentherapie
state: Niedersachsen
city: Bocholt
country: Germany
facility: Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital
state: Nordrhein-Westfalen
city: Gelsenkirchen
country: Germany
facility: Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie
state: Nordrhein-Westfalen
city: Saarlouis
country: Germany
facility: Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus
state: Saarland
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden, Strahlentherapie
state: Sachsen
city: Zwickau
country: Germany
facility: Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie
state: Sachsen
city: Kiel
country: Germany
facility: Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
city: Stendal
country: Germany
facility: Johanniter-Krankenhaus Genthin-Stendal
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Jürgen Dunst, Professor
role: STUDY_DIRECTOR
References:
citation: Krug D, Vonthein R, Illen A, Olbrich D, Barkhausen J, Richter J, Klapper W, Schmalz C, Rody A, Maass N, Bauerschlag D, Hessler N, Konig IR, Dellas K, Dunst J. Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients with Oligometastatic Breast Cancer: Study protocol for a randomized controlled multi-national and multi-center clinical trial (OLIGOMA). Clin Transl Radiat Oncol. 2021 Apr 5;28:90-96. doi: 10.1016/j.ctro.2021.03.012. eCollection 2021 May.