3522 - A Randomized Study of Head and Neck Radiotherapy with or without Customized 3D Printed Oral Stents
Presenter(s)
A. Lee1, R. Tino2, M. Roach2, G. Fuentes1, A. Agrawal2, M. Zaid2, D. J. Cooper3, R. Lin2, L. Xiao2, L. L. Mayo2, L. R. Wiederhold2, S. J. Shah1, G. M. Chronowski1, J. P. Reddy2, M. Mezera4, J. M. Mann4, M. Augspurger5, A. Otun6, M. S. Chambers6, and E. J. Koay7; 1Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 2Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, 3Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, 4Department of Radiation Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, 5Baptist Cancer Center, Jacksonville, FL, 6Department of Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, 7Department of Gastrointestinal Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX
Purpose/Objective(s):
Customized oral stents are utilized in patients undergoing radiotherapy for head and neck malignancies for reproducibility and minimization of dose to non-target structures. However, traditional fabrication is often resource-intensive leading many centers to treat patients without a device. We previously published the design and digital workflow of the 3D printed oral stent (PMID 39024700, 41250211). The purpose of this ongoing prospective study is to evaluate physician-assessed mucositis rates in non-target mucosa of patients who receive head and neck radiation as well as measure patient-reported outcomes (PROs) in these patients with or without a customized 3D printed oral stent.Materials/Methods:
In this prospective clinical trial, patients undergoing fractionated head and neck radiotherapy in both the definitive and postoperative setting are randomized in 3:2 fashion to customized 3D printed oral stent versus standard of care (SOC; no stent/non-customized device). Stratification is by receipt of concurrent chemotherapy and T-stage of tumor. The co-primary endpoints are physician-assessed mucositis rates in non-target mucosa defined as cumulative mean Oral Mucositis Assessment Scale (OMAS) score greater than 2 from baseline, week 3 of RT, final week of RT and at post treatment intervals in addition to PROs using the MDASI-HN score of 6 or higher at week 6 of treatment. The secondary objectives are to evaluate patient narcotic use during and post RT, evaluate imaging and dosimetric differences between the arms of the study and record any treatment disruptions. The study includes a lead-in phase for training purposes for each participating site. Analysis will be to assess superiority of the 3D custom oral stent compared to SOC for the primary endpoints in the intent-to-treat (ITT) randomized population. The trial (NCT05126797) is near completion of accrual with target goal of 55 evaluable randomized patients.Results: TBD
Conclusion: TBD