Metastatic Breast CancerOLIGOMANCT04495309
Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer
A study testing Metastases-directed Radiotherapy in people with Metastatic Breast Cancer, run by University Hospital Schleswig-Holstein at 14 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Metastases-directed Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 14 sitesGermany
- Study dates
- 5 Mar 2021to 3 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- relevant comorbidity, if this results in restrictions for further therapy
- Incapacity to contract or lack of informed consent
- Pregnancy and lactation
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital
Bocholt, North Rhine-Westphalia, 46397
Städtisches Klinikum Dresden, Strahlentherapie
Dresden, Saxony, 01067
Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie
Frankfurt (Oder), Brandenburg, 15236
Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie
Gelsenkirchen, North Rhine-Westphalia, 45879
GSR Hameln im Sana Klinikum Hameln-Pyrmont
Hamelin, Lower Saxony, 31785
Gemeinschaftspraxis für Strahlentherapie
Hildesheim, Lower Saxony, 31135
Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie
Mannheim, Baden-Wurttemberg, 68167
Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie
Marburg, Hesse, 35033
Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus
Saarlouis, Saarland, 66740
Johanniter-Krankenhaus Genthin-Stendal
Stendal, 39576
Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
Weilheim, Bavaria, 82362
MVZ WOB GmbH Strahlentherapie
Wolfsburg, Lower Saxony, 38440
Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie
Zwickau, Saxony, 08060
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Metastases-directed Radiotherapy
- Keywords
- Oligometastatic Breast Cancer, Radiotherapy, Progression-free survival (PFS)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metastases-directed RadiotherapyRadiation
Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Metastases-directed Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 12 weeks after randomization
Secondary outcomes (7)
Feasibility (per-protocol within intention-to-treat)
Proportion of participants treated per protocol
Measured: 12 weeks
Overall survival
Time between randomization and death
Measured: 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
Measured: 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
Measured: quarterly up to 5 years
Breast cancer-specific quality of life
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
Measured: 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
Measured: 12 weeks
Frequency of adverse events
Number of patients with adverse and serious adverse events
Measured: 0 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start5 Mar 2021
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jürgen Dunst, Professor, Study director, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495309
- Sponsor's protocol ID
- ARO-2015-1
- Acronym
- OLIGOMA
- Status last verified
- Dec 2025
- First submitted
- 9 Jun 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33912695
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04495309
- Acronym / sponsor ID
- OLIGOMA / ARO-2015-1
- Conditions
- Metastatic Breast Cancer
- Keywords
- Oligometastatic Breast Cancer, Radiotherapy, Progression-free survival (PFS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Radiation: Metastases-directed RadiotherapyStandard of care (standard systemic therapy) + study intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metastases-directed RadiotherapyAblative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions | Radiation | Experimental |
Primary outcome
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)
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
7 secondary outcomes
Feasibility (per-protocol within intention-to-treat)
Time frame: 12 weeks
Overall survival
Time frame: at least 1, up to 5 years
Toxicity (number and degree of reported toxicities in both treatment arms)
Time frame: 0 to 5 years
Neoplasia-specific quality of life
Time frame: quarterly up to 5 years
Breast cancer-specific quality of life
Time frame: quarterly up to 5 years
Patient satisfaction
Time frame: 12 weeks
Frequency of adverse events
Time frame: 0 to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 33912695Krug 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Dunst, Professor study director
University Hospital Schleswig-Holstein
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metastases-directed Radiotherapy in people with Metastatic Breast Cancer, run by University Hospital Schleswig-Holstein at 14 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First co-primary outcome measure is progression-free survival (PFS) (time frame: at least 12 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04495309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.