NCT06445114

Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer

ULTRA-HPV Using Circulating Tumor DNA to Risk Adapt Post-operative Therapy for HPV Associated Oropharyngeal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Zachary Zumsteg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Oropharyngeal Cancer
• Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Low risk pathology with post-op HPV DNA (-): cisplatin-based chemoradiation with 30 Gy in 15 fractions and 3 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, and 15 of radiation. Low risk pathology with post-op HPV DNA (+): cisplatin-based chemoradiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation. High risk pathology with post-op HPV DNA (-), excluding patients with both 5 LN+ and ENE+ or pre-op HPV DNA≤12 copies/mL: cisplatin-based radiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation. High risk pathology with post-op HPV DNA (+) OR pre-op HPV DNA≤12 copies/mL OR both 5 or more LN+ and ENE+: cisplatin-based radiation with 50 Gy in 25 fractions with 5 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, 22, and 29 of radiation.

Timeline

• Start date: 2025-05-12
• Primary completion: 2032-06-01
• Completion: 2032-06-01
• First posted: 2024-06-06
• Last updated: 2025-11-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study