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
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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 |
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 |
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)
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Experimental: Experimental
Standard of care (standard systemic therapy) + study intervention
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Radiation: Metastases-directed Radiotherapy
Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions |
- 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
- Feasibility (per-protocol within intention-to-treat) [ Time Frame: 12 weeks ]Proportion of participants treated per protocol
- Overall survival [ Time Frame: at least 1, up to 5 years ]Time between randomization and death
- 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
- 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
- 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
- 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
- Frequency of adverse events [ Time Frame: 0 to 5 years ]Number of patients with adverse and serious adverse events
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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 |
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
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
Contact: Kathrin Dellas, Professor | 0431/500/26570 | Kathrin.Dellas@uksh.de |
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 |
Study Director: | Jürgen Dunst, Professor | University Hospital Schleswig-Holstein |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Oligometastatic Breast Cancer Radiotherapy Progression-free survival (PFS) |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |