Comparison of Brain MRI Surveillance Alone Versus Prophylactic Cranial Irradiation Plus MRI in Small-Cell Lung Cancer Treatment

What this Trial Is About

Researchers are evaluating treatments for patients with small cell lung cancer SCLC to determine if brain MRI surveillance alone is not worse than prophylactic cranial irradiation PCI combined with brain MRI surveillance in terms of overall survival. This phase III study also aims to compare cognitive failure free survival, quality of life, cognitive functioning, and safety between these two approaches. Additional exploratory goals include evaluating survival and cognitive outcomes in various patient subgroups and assessing cost-effectiveness. Participants are randomly assigned to one of two groups. One group receives prophylactic cranial irradiation at 25 Gy in 10 fractions plus scheduled brain MRI scans at specific intervals up to 24 months. The other group undergoes active brain MRI surveillance without radiation, with clinical evaluations every three months. Imaging of other body areas is done as needed based on the treating physicians judgment. During the study, participants will have brain MRIs before randomization and at 3, 6, 9, 12, 18, and 24 months. Clinical evaluations will be conducted regularly, and researchers will collect data on survival, cognitive function, quality of life, and treatment safety. Blood samples will also be collected for biobanking. The overall participation lasts up to two years, with ongoing monitoring of health and quality of life.

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)