Planned regulatory approval
COMPLICATIONS
Since the NEXUS trial is a single-arm study, the efficacy and safety data will be compared with those of the RWD in the registry, wherein treatments other than this protocol treatment were administered to the same subjects. PFS, DFS, OS, and incidence of surgery-related complications in the NEXUS trial will be compared with those extracted from the regulatory-graded prospective large-scale nationwide clinico-patho-genomic registry (GALAXY trial) [