Brain metastases (BMs) cause significant morbidity and mortality, and the incidence is increasing. With continuous developments in neurosurgery, radiation techniques such as stereotactic radiotherapy, and novel systemic therapies, treatment decisions have become more challenging. Also, the role of whole brain radiotherapy is being debated due to its marginal survival benefits and potentially significant side-effects. International guidelines on treatment and follow-up exist, but the scientific evidence supporting these guidelines is limited. To improve patient-centered care and promote shared decision-making, systematic, population-based registrations of patient, disease, treatment, and outcome variables are necessary. We have launched a prospective cohort study in the South-East health-care region of Norway (appr. 3 million inhabitants). The study population will consist of consecutive patients newly diagnosed with BMs recruited over a two-year period. Follow-up will be for up to two years or until death. The primary aim is to establish a prospective, clinical registry with data on diagnostics, treatment, and follow-up, including Patient Reported Outcome Measures (PROMs). With this prospective information, evidence-based diagnostic and treatment algorithms and follow-up guidelines can be developed. Study outcomes include: • Detailed description of the study cohort (including patient-, disease-, and treatment characteristics) • Overall survival (from BM diagnosis) • Association between disease, treatment, and patient characteristics and survival • Patient reported symptoms and quality of life.
This is a prospective cohort study conducted in the South-East health-care region of Norway. Inclusion criteria: •Radiologically confirmed BMs from solid cancers diagnosed during the study period, regardless of planned treatment for BM. •No previous treatment for BMs •Age > 18 years Timeframe: Two-year consecutive inclusion, started November 2017. Estimated target population: 1,000 cases Data collection: Clinical data are registered every 3 months for up to 24 months. Patient- reported symptoms and quality of life are assessed with standardized questionnaires (EORTC QLQ-C15-PAL, BN-20, and EQ-5D) monthly for up to 12 months.
Clinical trial identification
Legal entity responsible for the study
Oslo University Hosptial.
Norwegian Cancer Society, South-East Health Region in Norway.
All authors have declared no conflicts of interest.