Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With HPV+ Oropharyngeal Squamous Cell Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

July 10, 2020

Study Completion Date

July 12, 2022

Conditions
Oropharyngeal Squamous Cell Cancer
Interventions
PROCEDURE

Neck Dissection

All patients will undergo neck dissection of the cervical lymph nodes

PROCEDURE

Standard-of-Care (SOC) Transoral Surgery of Primary Site

Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site.

RADIATION

SOC Radiation

Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation.

DRUG

SOC Carboplatin

Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel).

DRUG

SOC Paclitaxel

Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel).

PROCEDURE

Videofluoroscopy

All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.

Trial Locations (1)

48109

University of Michigan Cancer Center, Ann Arbor

All Listed Sponsors
lead

University of Michigan Rogel Cancer Center

OTHER

NCT02784288 - Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With HPV+ Oropharyngeal Squamous Cell Cancer | Biotech Hunter | Biotech Hunter