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

Primary Purpose

Metastatic Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Metastases-directed Radiotherapy
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Oligometastatic Breast Cancer, Radiotherapy, Progression-free survival (PFS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsmedizin Mannheim Klinik für Strahlentherapie und RadioonkologieRecruiting
  • Praxis für Strahlentherapie und Radioonkologie am Krankenhaus WeilheimRecruiting
  • Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/RadioonkologieRecruiting
  • Universitätsklinikum Marburg Klinik für Strahlentherapie und RadioonkologieRecruiting
  • GSR Hameln im Sana Klinikum Hameln-PyrmontRecruiting
  • Gemeinschaftspraxis für StrahlentherapieRecruiting
  • MVZ WOB GmbH StrahlentherapieRecruiting
  • Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-HospitalRecruiting
  • Evangelische Kliniken Gelsenkirchen Klinik für StrahlentherapieRecruiting
  • Xcare Praxis für Strahlentherapie Saarlouis am MarienkrankenhausRecruiting
  • Städtisches Klinikum Dresden, StrahlentherapieRecruiting
  • Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und RadioonkologieRecruiting
  • Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus KielRecruiting
  • Johanniter-Krankenhaus Genthin-StendalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard

Experimental

Arm Description

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

Standard of care (standard systemic therapy) + study intervention

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Feasibility (per-protocol within intention-to-treat)
Proportion of participants treated per protocol
Overall survival
Time between randomization and death
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
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
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
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
Frequency of adverse events
Number of patients with adverse and serious adverse events

Full Information

First Posted
June 9, 2020
Last Updated
April 27, 2021
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT04495309
Brief Title
Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer
Acronym
OLIGOMA
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Oligometastatic Breast Cancer, Radiotherapy, Progression-free survival (PFS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
564 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
No Intervention
Arm Description
Standard of care, i. e. no local radiotherapy in addition to standard systemic therapy (exception: palliative local treatment of symptomatic lesions where indicated)
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Standard of care (standard systemic therapy) + study intervention
Intervention Type
Radiation
Intervention Name(s)
Metastases-directed Radiotherapy
Intervention Description
Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions
Primary Outcome Measure Information:
Title
First co-primary outcome measure is progression-free survival (PFS)
Description
Co-primary progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST)
Time Frame
at least 12 months after randomization
Title
Second co-primary outcome measure is quality of life
Description
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
Time Frame
12 weeks after randomization
Secondary Outcome Measure Information:
Title
Feasibility (per-protocol within intention-to-treat)
Description
Proportion of participants treated per protocol
Time Frame
12 weeks
Title
Overall survival
Description
Time between randomization and death
Time Frame
at least 1, up to 5 years
Title
Toxicity (number and degree of reported toxicities in both treatment arms)
Description
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
Time Frame
0 to 5 years
Title
Neoplasia-specific quality of life
Description
Research and Treatment of Cancer (EORTC) Quality of Life Questionaire for Cancer patients with 30 items (QLQ-C30) with different scales
Time Frame
quarterly up to 5 years
Title
Breast cancer-specific quality of life
Description
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
Time Frame
quarterly up to 5 years
Title
Patient satisfaction
Description
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
Time Frame
12 weeks
Title
Frequency of adverse events
Description
Number of patients with adverse and serious adverse events
Time Frame
0 to 5 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients with oligometastatic breast cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathrin Dellas, Professor
Phone
0431/500/26570
Email
Kathrin.Dellas@uksh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Dunst, Professor
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Sperk, MD
Phone
0049/621 383 4241
Email
elena.sperk@umm.de
Facility Name
Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
City
Weilheim
State/Province
Bayern
ZIP/Postal Code
82362
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Panzer, MD
Phone
0049/88192452340
Email
mpa@strahlentherapie-weilheim.de
First Name & Middle Initial & Last Name & Degree
Michaela Riepl, MD
Phone
0049/88192452340
Email
mrp@strahlentherapie-weilheim.de
Facility Name
Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie
City
Frankfurt (Oder)
State/Province
Brandenburg
ZIP/Postal Code
15236
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reinhard E. Wurm, MD
Phone
0049/335 548 4721
Email
reinhard.wurm@klinikumffo.de
Facility Name
Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35033
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilke Vorwerk, Prof.
Phone
0049/6421 58 66270
Email
hilke.vorwerk@med.uni-marburg.de
Facility Name
GSR Hameln im Sana Klinikum Hameln-Pyrmont
City
Hameln
State/Province
Niedersachsen
ZIP/Postal Code
31785
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Janssen, MD
Phone
0049/5151 9626320
Email
stefan.janssen@strahlentherapie.de
Facility Name
Gemeinschaftspraxis für Strahlentherapie
City
Hildesheim
State/Province
Niedersachsen
ZIP/Postal Code
31135
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susann Popella, MD
Phone
0049/5121 8942 913
Email
spopella@strahlentherapie-hildesheim.de
Facility Name
MVZ WOB GmbH Strahlentherapie
City
Wolfsburg
State/Province
Niedersachsen
ZIP/Postal Code
38440
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcel Ott, MD
Phone
0049/5361 803850
Email
Marcel.Ott@Klinikum.Wolfsburg.de
Facility Name
Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital
City
Bocholt
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46397
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eckhard Horst, MD
Phone
0049/2871 246540
Email
horst@strahlentherapie-bocholt.de
Facility Name
Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie
City
Gelsenkirchen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45879
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Hepp, MD
Phone
0049/209 160 53001
Email
heppdelosrios@evk-ge.de
Facility Name
Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus
City
Saarlouis
State/Province
Saarland
ZIP/Postal Code
66740
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sevda Toperim
Phone
0049/6831 161229
Email
sevda.toperim@x-care.de
Facility Name
Städtisches Klinikum Dresden, Strahlentherapie
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Schreiber, MD
Phone
0049/3514803500
Email
Andreas.Schreiber@klinikum-dresden.de
First Name & Middle Initial & Last Name & Degree
Jörg Zimmer, MD
Phone
0049/3514803501
Email
Zimmer-Jo@khdf.de
Facility Name
Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie
City
Zwickau
State/Province
Sachsen
ZIP/Postal Code
08060
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Boicev, MD
Phone
0049/375512802
Email
alexander.boicev@hbk-zwickau.de
Facility Name
Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juergen Dunst, Prof.
Phone
0049/431/50026500
Email
Juergen.Dunst@uksh.de
First Name & Middle Initial & Last Name & Degree
Kathrin Dellas, Prof.
Phone
0049/431/50026570
Email
Kathrin.Dellas@uksh.de
Facility Name
Johanniter-Krankenhaus Genthin-Stendal
City
Stendal
ZIP/Postal Code
39576
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Weinstrauch, MD
Phone
0049/3931 661504
Email
evelyn.weinstrauch@sdl.johanniter-kliniken.de
First Name & Middle Initial & Last Name & Degree
Sachsen-Anhalt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33912695
Citation
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.
Results Reference
derived

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

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