Study Monitoring
toxic, Cancer
CANCER
The Mayo Clinic Comprehensive Cancer Center data safety and monitoring board monitored the trial every 6 months. The safety stopping rules applied to each arm separately. If 3 or more of the first 10 patients or 30% or more of patients randomized to the arm thereafter developed a grade 4 toxic effect that was possibly, probably, or definitely related to treatment, then enrollment would be temporarily suspended until the study chair and biostatistician recommendations were approved by coinvestigators.