Ethics and study participant safety
The study has been approved by the Cantonal Ethics Committee of Zurich, Switzerland (BASEC 2022 − 00262). This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, ICH-GCP, as well as all national legal and regulatory requirements. An independent data and safety monitoring board (DSMB) including a board-certified radiation oncologist and cardiologist/electrophysiologist has been established. The DSMC will review and evaluate the accumulated study data for subject safety, study conduct and progress, and make suggestions concerning the continuation, modification, or termination of the study. DSMB meetings will be scheduled before the trial start, after enrollment of the first 2 subjects and another 3 subjects, or at least every 6 months. The trial has been registered at clinicaltrials.gov (NCT05594368).