Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer

NCT04495309 | Completed DMC

• 1 other identifier: ARO-2015-1
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 14

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.

Conditions

Metastatic Breast Cancer

Keywords

Oligometastatic Breast Cancer; Radiotherapy; Progression-free survival (PFS)

Outcome Measures

Primary Outcomes (2)

• First co-primary outcome measure is progression-free survival (PFS)

  Co-primary progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST)

  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

  12 weeks after randomization

Secondary Outcomes (7)

• Feasibility (per-protocol within intention-to-treat)

  12 weeks

• Overall survival

  at least 1, up to 5 years

• Toxicity (number and degree of reported toxicities in both treatment arms)

  0 to 5 years

• Neoplasia-specific quality of life

  quarterly up to 5 years

• Breast cancer-specific quality of life

  quarterly up to 5 years

Study Arms (2)

Standard

NO INTERVENTION

Standard of care, i. e. no local radiotherapy in addition to standard systemic therapy (exception: palliative local treatment of symptomatic lesions where indicated)

Experimental

EXPERIMENTAL

Standard of care (standard systemic therapy) + study intervention

Radiation: Metastases-directed Radiotherapy

Interventions

Metastases-directed Radiotherapy RADIATION

Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions

Experimental

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients with oligometastatic breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous radiotherapy, if this interferes with treatment within the scope of the study
• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (14)

Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim

Weilheim, Bavaria, 82362, Germany

Location

Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie

Frankfurt (Oder), Brandenburg, 15236, Germany

Location

Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie

Marburg, Hesse, 35033, Germany

Location

GSR Hameln im Sana Klinikum Hameln-Pyrmont

Hamelin, Lower Saxony, 31785, Germany

Location

Gemeinschaftspraxis für Strahlentherapie

Hildesheim, Lower Saxony, 31135, Germany

Location

MVZ WOB GmbH Strahlentherapie

Wolfsburg, Lower Saxony, 38440, Germany

Location

Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital

Bocholt, North Rhine-Westphalia, 46397, Germany

Location

Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie

Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

Location

Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus

Saarlouis, Saarland, 66740, Germany

Location

Städtisches Klinikum Dresden, Strahlentherapie

Dresden, Saxony, 01067, Germany

Location

Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie

Zwickau, Saxony, 08060, Germany

Location

Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Johanniter-Krankenhaus Genthin-Stendal

Stendal, 39576, Germany

Location

Related Publications (1)

• 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.

  PMID: 33912695 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jürgen Dunst, Professor

  University Hospital Schleswig-Holstein

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: July 31, 2020
• Study Start: March 5, 2021
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: February 27, 2026

Record last verified: 2025-12

Locations

DE (14)