Conclusion
Review of pediatric dose-volume constraints in clinical trials showed
substantial variability for all OARs, both for US trials and for
European relative to US trials. None of the OARs had constraints
systematically change over time, indicating that the variations seen
were not due to the application of new dose-response information, but
more likely due to a lack of both robust dose-response data and
consensus by protocol committee members who establish the constraints.
Continued efforts focused on standardization of OAR dose constraints and
risk profiles are essential to increase consistency of protocol outcomes
and ultimately to reduce radiation toxicities in the pediatric
population.