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

University Hospital Schleswig-Holstein (UKSH)

Status: Enrolling

Conditions: Metastatic Breast Cancer

Treatments: Radiation: Metastases-directed Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04495309

ARO-2015-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 564 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

564 participants in 2 patient groups

Standard

No Intervention group

Description:

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 group

Description:

Standard of care (standard systemic therapy) + study intervention

Treatment:

Radiation: Metastases-directed Radiotherapy