Phase II Trial Evaluating Elimination of Radiation Therapy To Pathological N0 Neck(s) With Intensity Modulated Postoperative Radiation Therapy
The proposed study will prospectively test whether this method of volume reduction can be
implemented without a change in the historical institutional locoregional control rate
achieved with intensity modulated postoperative radiation therapy (IMPORT). Quality of life
measurements via validated instruments will be incorporated to establish correlation of
volume reduction with QOL.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Eliminate radiation of PN0 neck(s) and demonstrate >90% control in the unirradiated neck(s)
Recurrence in a PN0 neck that was not treated is the critical endpoint in this study.
12 months of follow-up
Wade Thorstad, MD
Washington University School of Medicine
United States: Institutional Review Board
07-0142 / 201106342
|Washington University School of Medicine||Saint Louis, Missouri 63110|