Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

PHASE2RecruitingINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

March 7, 2024

Primary Completion Date

October 18, 2025

Study Completion Date

October 18, 2027

Conditions
Head and Neck CancerHead and Neck Squamous Cell CarcinomaOropharynx CancerOropharynx Squamous Cell CarcinomaHPV Positive Oropharyngeal Squamous Cell Carcinoma
Interventions
OTHER

Experimental Observation

Patients on the experimental arm will be under observation only.

OTHER

Observation per Standard of Care

The low-risk group of patients will be observed per standard of care.

RADIATION

Adjuvant Treatment per Standard of Care

The high-risk group of patients will receive adjuvant treatment per standard of care (Radiation with or without chemotherapy)

DIAGNOSTIC_TEST

Circulating Tumor DNA test (ctDNA test)

Blood test for diagnostic and surveillance purposes measuring expression of Cell free HPV tumor DNA (ctDNA) in the blood. Patients will undergo ctDNA within 90 days pre-transoral robotic surgery(TORS), 2-14 days post TORS, then every 3 months (except for at 21 months) for 2 year post completion of initial therapy or salvage therapy.

Trial Locations (5)

21014

NOT_YET_RECRUITING

Upper Chesapeake Health, Bel Air

21044

NOT_YET_RECRUITING

Central Maryland Radiation Oncology, Columbia

21061

NOT_YET_RECRUITING

Baltimore Washington Medical Center, Glen Burnie

21201

RECRUITING

Maryland Proton Treatment Center, Baltimore

RECRUITING

University of Maryland Greenebaum Cancer Center, Baltimore

All Listed Sponsors
lead

University of Maryland, Baltimore

OTHER