Skip to main content
OpenTrials
Completed

NCT Number: NCT04495309

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie, Mannheim, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metastases-directed Radiotherapy

Radiation

Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study 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

Acronym: OLIGOMA

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.