TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck

NAActive, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

October 11, 2018

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Oropharyngeal CancerSquamous Cell CarcinomaHuman Papilloma Virus
Interventions
RADIATION

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."

Trial Locations (1)

19104

University of Pennsylvania, Philadelphia

All Listed Sponsors
lead

Abramson Cancer Center at Penn Medicine

OTHER

NCT03729518 - TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck | Biotech Hunter | Biotech Hunter