NCT05541016 - De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA | Biotech Hunter

Enrollment

320

Participants

Timeline

Start Date

February 21, 2023

Primary Completion Date

August 1, 2028

Study Completion Date

August 1, 2029

Conditions

Oropharyngeal Human Papillomavirus-Positive Squamous Cell CarcinomaClinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and saliva specimen collection for NavDx testing

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

RADIATION

Diffusing Alpha-emitter Radiation Therapy

Undergo DART

DRUG

Docetaxel

Given IV

PROCEDURE

Intensity-Modulated Proton Therapy

Undergo IMPT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Modified Barium Swallow Study

Undergo MBSS

OTHER

Observation

Undergo observation

PROCEDURE

Positron Emission Tomography

Undergo PET scan

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire

Ancillary studies

Trial Locations (3)

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

85259

RECRUITING

Mayo Clinic in Arizona, Scottsdale

32224-9980

RECRUITING

Mayo Clinic in Florida, Jacksonville