Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligom… (NCT04495309) | Clinical Trial Compass
CompletedNot Applicable
Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer
Germany87 participantsStarted 2021-03-05
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
What they're measuring
1
First co-primary outcome measure is progression-free survival (PFS)
Timeframe: at least 12 months after randomization
2
Second co-primary outcome measure is quality of life