Background: Prophylactic cranial irradiation (PCI) is a current standard of care after confirmed response to radical\nchemoradiotherapy for limited disease small cell lung cancer (LD-SCLC). This standard is mostly based on results of\nold randomized studies when brain imaging with magnetic resonance (MRI) was not available. Survival benefit of\nPCI in extended disease SCLC was recently challenged by the results of randomized phase III study from Japan.\nMethods: Eighty patients with LD-SCLC after response to chest chemoradiotherapy will be enrolled. Patients will be\nfollowed up by brain MRI every 3 to 6 months up to 3 years. Neurocognitive function tests will be performed at\nbaseline and after 12 and 24 months. Patients who develop brain metastases will be irradiated with stereotactic\n(SRT) or whole brain RT (WBRT). The primary endpoint is overall survival. The secondary endpoints are: response rate\nto radiotherapy of early detected brain metastases, analysis of efficacy of SRT and WBRT; assessment and analysis of\nneurocognitive functions and QoL in the studied cohorts: QLQ-C30 questionnaire and the California Verbal Learning\nTest, Color connection test, Benton visual retention test, and verbal fluency test will be carried out.\nDiscussion: The results of this trial may contribute to changing of LD-SCLC clinical management by deescalating\nthe treatment. There is a lack of prospective, recent studies in LD-SCLC patients with omission of PCI and modern\nradiation therapy technologies for developed brain metastases. The comprehensive neurocognitive function testing\nwill help to assess the impact of modern radiotherapy (SRT) compared with WBRT and no-PCI in SCLC patients. A\nsubgroup of long-term survivors, who will not develop brain metastases, will not be exposed to unnecessary brain\nirradiation with its deleterious consequences. The limitation of our study is a lack of parallel randomized control\narm. This is a potential source of bias; however, randomized study will be difficult to complete for two major\nreasons: (1) limited population of LD-SCLC eligible for the study and (2) opinions of our patients, who after\ninformation and discussion about benefits and potential harms of PCI, often choose to omit PCI in our practice.\nTrial registration: ClinicalTrials.gov Identifier: NCT04168281, 19 Nov. 2019.
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