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Shortened Course Adjuvant Radiotherapy Following TORS

Oropharyngeal Squamous Cell Carcinoma Clinical Trial

Official title:
A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma

Clinical Trial Summary

This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected p16+ OPSCC patients receiving adjuvant radiation after TORS and neck dissection. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.

Clinical Trial Description

This is a single-arm, phase II study of dose-reduced, adjuvant radiotherapy (10 treatments over 2 weeks) for patients with p16+ oropharyngeal squamous cell carcinoma after completion of transoral robotic resection (TORS) and selective neck dissection (SND). Selected patients will be required to have measurable preoperative circulating tumor human papillomavirus DNA (ctHPVDNA) and undetectable postoperative (pre-radiotherapy) ctHPVDNA. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group (AVOID trial, Swisher-McClure et al. 2020) and found to be safe and effective. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05714657
Study type Interventional
Source Abramson Cancer Center at Penn Medicine
Contact Alexander Lin, MD
Phone 2156623198
Email Alexander.Lin2@pennmedicine.upenn.edu
Status Recruiting
Phase N/A
Start date January 30, 2023
Completion date April 30, 2025
View Details
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