OncoMatch/Clinical Trials/NCT05541016
De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
Is NCT05541016 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cisplatin and Docetaxel for clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Treatment: Cisplatin · Docetaxel — This phase II trial examines the use of blood-based biomarkers is to help inform decision making for treatment and radiation therapy for patients with human papillomavirus (HPV) positive oropharyngeal squamous cell cancers. The standard treatments for head and neck cancers are radiation therapy with chemotherapy or surgery potentially followed by radiation therapy with or without chemotherapy. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving chemotherapy along with radiation may kill more tumor cells. However, the cancer can recur or can spread to other parts of the body and all treatments can be associated with side effects. The purpose of this study is to evaluate a blood-based biomarker, using the NavDx testing device, for head and neck cancers in order to see if it can help improve selection of the intensity of treatment in order to best balance the side effects of treatment with the goal of decreasing cancer recurrence. This test could aid in early detection of recurrence and salvage therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Allowed: HPV HPV-mediated (p16-positive)
HPV-Mediated (p16-Positive)
Allowed: HPV HPV-negative (p16-negative)
p16-Negative
Disease stage
Required: Stage I, II, III (AJCC v8)
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8; cT4 primary tumor [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Prior history of radiation therapy to the affected site
Cannot have received: systemic chemotherapy
Exception: in the last 5 years
Prior systemic chemotherapy in the last 5 years
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Arizona · Scottsdale, Arizona
- Mayo Clinic in Florida · Jacksonville, Florida
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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