Evidence map›Paper›PMID 33912695›Full record

ArticleClinical and translational radiation oncology2021

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).

David Krug, Reinhard Vonthein, Alicia Illen, Denise Olbrich, Jörg Barkhausen, Julia Richter, Wolfram Klapper, Claudia Schmalz, Achim Rody, Nicolai Maass and 5 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Clinical and translational radiation oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04495309 (Effectiveness and Tolerability of Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
4.1field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04495309 nacompletednot on this map

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

TypeinterventionalSponsorUniversity Hospital Schleswig-HolsteinRan2021 to 2025Enrolled87ConditionsMetastatic Breast CancerArmsMetastases-directed Radiotherapy
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 30 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Personalized treatment approach for HER2-positive metastatic breast cancer.Medical oncology (Northwood, London, England) · 2024
    Review
  6. Article
  7. Article
  8. Local treatment in oligometastasis from breast cancer: an overview.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Review
  9. Article
  10. Ten-year experience of bone SBRT in breast cancer: analysis of predictive factors of effectiveness.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Article
  11. Unravelling oligometastatic disease from the perspective of radiation and medical oncology. Part I: non-small cell lung cancer and breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Article
  12. [Frontiers in nuclear medicine · 2023
    Article
  13. Review
  14. A Precise Approach for Radiotherapy of Breast Cancer.Cancer treatment and research · 2023
    Article
  15. Locoregional treatment ofFrontiers in oncology · 2023
    Review
  16. Oligometastasis in breast cancer-current status and treatment options from a radiation oncology perspective.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2022
    Review
  17. Review
  18. Article
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 5 institutions in 1 country.

David KrugKlinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Kiel, Deutschland.
Reinhard VontheinInstitut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Deutschland.
Alicia IllenZKS Lübeck, Universität zu Lübeck, Lübeck, Deutschland.
Denise OlbrichZKS Lübeck, Universität zu Lübeck, Lübeck, Deutschland.
Jörg BarkhausenKlinik für Radiologie und Nuklearmedizin, Universitätsklinikum Schleswig-Holstein, Lübeck, Deutschland.
Julia RichterSektion für Hämatopathologie, Institut für Pathologie, Universitätsklinikum Schleswig-Holstein, Kiel, Deutschland.
Wolfram KlapperSektion für Hämatopathologie, Institut für Pathologie, Universitätsklinikum Schleswig-Holstein, Kiel, Deutschland.
Claudia SchmalzKlinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Kiel, Deutschland.
Achim RodyKlinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Lübeck, Deutschland.
Nicolai MaassKlinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Kiel, Deutschland.
Dirk BauerschlagKlinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Kiel, Deutschland.
Nicole HeßlerInstitut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Deutschland.
Inke R KönigInstitut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Deutschland.
Kathrin DellasKlinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Kiel, Deutschland.
Jürgen DunstKlinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Kiel, Deutschland.
University of Lübeck · DEUniversity Hospital Schleswig-Holstein · DEUniversitätsklinik für Strahlentherapie · DEKlinik für Frauenheilkunde · DEKlinik und Poliklinik für Nuklearmedizin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeveral recent randomized therapeutic exploratory trials demonstrated improvement of progression-free survival and in some even overall survival using stereotactic body radiotherapy in patients with oligometastatic disease. However, only very few patients enrolled in these trials had breast cancer, and results from confirmatory trials are lacking. METHODS/

designThe OLIGOMA-trial is a randomized controlled multi-national multi-center therapeutic confirmatory trial studying the role of local ablative radiotherapy as an additive treatment in patients with oligometastatic breast cancer receiving standard systemic therapy. Patients will be randomized 1:1 to standard systemic therapy according to national guidelines with or without radiotherapy to all metastatic sites. Randomization will be stratified according to type and line of systemic therapy, which has to be determined by a multidisciplinary tumor board before enrollment. Patients with up to five metastatic lesions are eligible, including patients with up to three brain metastases (only in case of extracranial disease) and with locoregional recurrence (only in case of additional metastatic lesions). In the standard arm, palliative radiotherapy to symptomatic metastases is permitted if at least one lesion remains untreated. The co-primary endpoints are progression-free survival and quality of life. The primary hypothesis is that progression-free survival in the experimental arm will be superior to the standard arm while simultaneously demonstrating non-inferiority of quality of life at 12 weeks after randomization. Secondary endpoints are feasibility, overall survival, toxicity, quality of life and patient satisfaction. A translational sub-study with collection of ctDNA will be conducted. DISCUSSION: The OLIGOMA-trial will provide high level evidence on the use of and benefit from local ablative radiotherapy for patients with oligometastatic breast cancer.

trial registrationThe OLIGOMA-trial is registered at clinicialtrials.gov under the identification NCT04495309. The related information was first posted on July 31st 2020.

Indexed as

Metastatic breast cancerProgression-free survivalQuality of lifeRadiosurgeryStereotactic ablative radiotherapyStereotactic body radiotherapy

Identifiers

PMID33912695
PMCPMC8065185
OpenAlexW3142240716

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.