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

Metastatic Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04495309
• Other study ID #: ARO-2015-1
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2021
• Source: University Hospital Schleswig-Holstein
• Contact: Kathrin Dellas, Professor
• Phone: 0431/500/26570
• Email: Kathrin.Dellas[@]uksh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 addition to standard systemic therapy in patients with oligometastatic breast cancer on progression-free survival and quality of life.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 564
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Radiation:
• Metastases-directed Radiotherapy
Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions

Locations

Country	Name	City	State
Germany	Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital	Bocholt	Nordrhein-Westfalen
Germany	Städtisches Klinikum Dresden, Strahlentherapie	Dresden	Sachsen
Germany	Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie	Frankfurt (Oder)	Brandenburg
Germany	Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie	Gelsenkirchen	Nordrhein-Westfalen
Germany	GSR Hameln im Sana Klinikum Hameln-Pyrmont	Hameln	Niedersachsen
Germany	Gemeinschaftspraxis für Strahlentherapie	Hildesheim	Niedersachsen
Germany	Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel	Kiel	Schleswig-Holstein
Germany	Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie	Mannheim	Baden-Württemberg
Germany	Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie	Marburg	Hessen
Germany	Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus	Saarlouis	Saarland
Germany	Johanniter-Krankenhaus Genthin-Stendal	Stendal
Germany	Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim	Weilheim	Bayern
Germany	MVZ WOB GmbH Strahlentherapie	Wolfsburg	Niedersachsen
Germany	Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie	Zwickau	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	at least 12 months after randomization
Primary	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	12 weeks after randomization
Secondary	Feasibility (per-protocol within intention-to-treat)	Proportion of participants treated per protocol	12 weeks
Secondary	Overall survival	Time between randomization and death	at least 1, up to 5 years
Secondary	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	0 to 5 years
Secondary	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	quarterly up to 5 years
Secondary	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	quarterly up to 5 years
Secondary	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	12 weeks
Secondary	Frequency of adverse events	Number of patients with adverse and serious adverse events	0 to 5 years