The rationale and development of a CyberKnife© registry for pediatric patients with CNS lesions.

Abstract

CyberKnife© Radiosurgery (CKRS) is a recognized treatment concept for CNS lesions in adults due to its high precision and efficacy beside a high patient comfort. However, scientific evidence for this treatment modality in pediatric patients is scarce. A dedicated registry was designed to document CyberKnife© procedures in children, aiming to test the hypothesis that it is safe and efficient for the treatment of CNS lesions. The CyberKnife© registry is designed as a retrospective and prospective multicenter observational study (German Clinical Trials Register ( https://www.drks.de ), DRKS-ID 00016973). Patient recruitment will be ongoing throughout a 5-year period and includes collection of demographic, treatment, clinical, and imaging data. Follow-up results will be monitored for 10 years. All data will be registered in a centralized electronic database at the Charité-Universitätsmedizin. The primary endpoint is stable disease for benign and vascular lesions at 5 years of follow-up and local tumor control for malign lesions at 1- and 2-year follow-up. Secondary endpoints are radiation toxicity, side effects, and neurocognitive development. The CyberKnife© registry intends to generate scientific evidence for all treatment- and outcome-related aspects in pediatric patients with treated CNS lesions. The registry may define safety and efficacy of CKRS in children and serve as a basis for future clinical trials, inter-methodological comparisons and changes of treatment algorithms.