The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Shortened Course Adjuvant Radiotherapy Following TORS
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
Study ID: NCT05714657
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Name: Alexander Lin, MD
Affiliation: Abramson Cancer Center
Role: PRINCIPAL_INVESTIGATOR