Clinical Research Directory
Browse clinical research sites, groups, and studies.
TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
Sponsor: Abramson Cancer Center at Penn Medicine
Summary
This is a single-arm Phase II study of adjuvant radiation for locally advanced p16+ oropharyngeal squamous cell carcinoma. The main purpose of this research is to determine the likelihood of cancer growing back in the throat or in the neck two years after completion of radiation if lower doses of radiation are used to a smaller area of the head and neck region than is currently used in standard of care.
Official title: A Phase II Study of Volume and Dose De-Intensification Following Transoral Robotic Surgery (TORS) and Neck Dissection for p16+ Oropharyngeal Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2018-10-11
Completion Date
2026-05
Last Updated
2026-02-20
Healthy Volunteers
No
Interventions
Radiation Therapy (IMRT or IMPT)
* Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In those patients requiring treatment of the primary site, reduced dose (50 Gy) will be delivered. * Receipt of concurrent chemotherapy per current guidelines. Chemotherapy may be omitted in patients with focal or microscopic ENE (defined as ≤ 1 mm ENE), at the discretion of the treating Medical Oncologist. * Blood samples will be obtained at time of enrollment, and at two time points during RT, to quantify circulating HPV DNA and perform immune profiling.
Locations (1)
University of Pennsylvania
Philadelphia, Pennsylvania, United States