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

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ClinicalTrials.gov Identifier: NCT04495309
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Schleswig-Holstein

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Radiation: Metastases-directed Radiotherapy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 5, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard
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
Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. Feasibility (per-protocol within intention-to-treat) [ Time Frame: 12 weeks ]
    Proportion of participants treated per protocol

  2. Overall survival [ Time Frame: at least 1, up to 5 years ]
    Time between randomization and death

  3. Toxicity (number and degree of reported toxicities in both treatment arms) [ Time Frame: 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

  4. Neoplasia-specific quality of life [ Time Frame: 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

  5. Breast cancer-specific quality of life [ Time Frame: 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

  6. Patient satisfaction [ Time Frame: 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

  7. Frequency of adverse events [ Time Frame: 0 to 5 years ]
    Number of patients with adverse and serious adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients with oligometastatic breast cancer
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495309


Contacts
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Contact: Kathrin Dellas, Professor 0431/500/26570 Kathrin.Dellas@uksh.de

Locations
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Germany
Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie Recruiting
Mannheim, Baden-Württemberg, Germany, 68167
Contact: Elena Sperk, MD    0049/621 383 4241    elena.sperk@umm.de   
Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim Recruiting
Weilheim, Bayern, Germany, 82362
Contact: Monika Panzer, MD    0049/88192452340    mpa@strahlentherapie-weilheim.de   
Contact: Michaela Riepl, MD    0049/88192452340    mrp@strahlentherapie-weilheim.de   
Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie Recruiting
Frankfurt (Oder), Brandenburg, Germany, 15236
Contact: Reinhard E. Wurm, MD    0049/335 548 4721    reinhard.wurm@klinikumffo.de   
Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie Recruiting
Marburg, Hessen, Germany, 35033
Contact: Hilke Vorwerk, Prof.    0049/6421 58 66270    hilke.vorwerk@med.uni-marburg.de   
GSR Hameln im Sana Klinikum Hameln-Pyrmont Recruiting
Hameln, Niedersachsen, Germany, 31785
Contact: Stefan Janssen, MD    0049/5151 9626320    stefan.janssen@strahlentherapie.de   
Gemeinschaftspraxis für Strahlentherapie Recruiting
Hildesheim, Niedersachsen, Germany, 31135
Contact: Susann Popella, MD    0049/5121 8942 913    spopella@strahlentherapie-hildesheim.de   
MVZ WOB GmbH Strahlentherapie Recruiting
Wolfsburg, Niedersachsen, Germany, 38440
Contact: Marcel Ott, MD    0049/5361 803850    Marcel.Ott@Klinikum.Wolfsburg.de   
Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital Recruiting
Bocholt, Nordrhein-Westfalen, Germany, 46397
Contact: Eckhard Horst, MD    0049/2871 246540    horst@strahlentherapie-bocholt.de   
Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie Recruiting
Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
Contact: Rodrigo Hepp, MD    0049/209 160 53001    heppdelosrios@evk-ge.de   
Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus Recruiting
Saarlouis, Saarland, Germany, 66740
Contact: Sevda Toperim    0049/6831 161229    sevda.toperim@x-care.de   
Städtisches Klinikum Dresden, Strahlentherapie Recruiting
Dresden, Sachsen, Germany, 01067
Contact: Andreas Schreiber, MD    0049/3514803500    Andreas.Schreiber@klinikum-dresden.de   
Contact: Jörg Zimmer, MD    0049/3514803501    Zimmer-Jo@khdf.de   
Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie Recruiting
Zwickau, Sachsen, Germany, 08060
Contact: Alexander Boicev, MD    0049/375512802    alexander.boicev@hbk-zwickau.de   
Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Juergen Dunst, Prof.    0049/431/50026500    Juergen.Dunst@uksh.de   
Contact: Kathrin Dellas, Prof.    0049/431/50026570    Kathrin.Dellas@uksh.de   
Johanniter-Krankenhaus Genthin-Stendal Recruiting
Stendal, Germany, 39576
Contact: Evelyn Weinstrauch, MD    0049/3931 661504    evelyn.weinstrauch@sdl.johanniter-kliniken.de   
Contact: Sachsen-Anhalt         
Sponsors and Collaborators
University Hospital Schleswig-Holstein
Investigators
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Study Director: Jürgen Dunst, Professor University Hospital Schleswig-Holstein
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT04495309    
Other Study ID Numbers: ARO-2015-1
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Schleswig-Holstein:
Oligometastatic Breast Cancer
Radiotherapy
Progression-free survival (PFS)
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases