Carcinoma Clinical Trial
Official title:
ULTRA-HPV Using Circulating Tumor DNA to Risk Adapt Post-operative Therapy for HPV Associated Oropharyngeal Cancer
This is a single institution phase II study that will enroll patients with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma (OSCC) undergoing resection of all gross visible disease at the primary site and in the lymph nodes.
All eligible patients will be treated with a de-intensified cisplatin-based chemoradiation regimen after undergoing transoral robotic surgery. Enrolled patients will be risk-assessed and assigned to specific regimens based on a combination of their post-operative cTTMV-HPV DNA, as determined by results from NavDx kits by Naveris, and pathologic features. All patients will receive a dose of 40 mg/m2 IV weekly concurrently with radiation therapy. Patients ineligible to receive cisplatin at this dose will undergo modified sydtemic therapy. Patients will recieve concurrent radiation in a dose of 30 Gy in 15 fractions to the primary tumor bed, ipsilateral neck +/- contralateral neck. Based on risk-stratification, some patients will receive a sequential boost of 10 Gy over 5 fractions or 20 Gy over 10 fractions. ;
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