JMIR Publications

ABSTRACT

Background Spinal metastases of lung cancer (SMLC) usually have high degree of malignancy and require systemic treatment. Patients of SMLC accompanied with clinical symptoms require surgical treatment, including local pain, emerging or potential spinal instability and progressive neurological dysfunction. However, there are controversies about the comparison of outcomes between surgical treatment and non-surgical treatment. The aim of this study is to 1) Compare the clinical outcomes of surgical treatment and non-surgical treatment for SMLC. 2) Explore the prognostic factors of SMLC. 3) Establish a survival predictive model based on the prognostic factors. Methods This is a prospective cohort study and plan to enroll 240 patients (120 patients in the surgical group and 120 patients in the non-surgical group). The demographic variables, health quality of life, radiological variables, clinical variables and treatment variables will be collected at baseline visit. Patients will be followed up at 3, 6, 12, 24 months after treatment and survival status are followed up every 3 months. The primary outcome is the overall survival (OS) period, while the secondary outcomes are progress-free survival (PFS) period, visual analogue scale (VAS) values, American Spinal Injury Association (ASIA) score, Karnosfsky performance score (KPS), Eastern Cooperative Oncology Group (ECOG) performance score and SF-36 questionnaire. Discussion In this study, we propose to set up a prospective cohort of patients with SMLC to investigate the outcomes between surgical treatment and non-surgical treatment. Through this study, we will explore the role of surgical treatment in SMLC and provide evidence and experience for surgeons. Trial registration This study has been registered on chictr.org.cn in July 4, 2021 (ChiCTR2100048151).