De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
Public ClinicalTrials.gov record NCT05541016. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05541016
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 455 participants
Conditions and interventions
Conditions
- 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
- Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma
- Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
- Biospecimen Collection Procedure
- Cisplatin Drug
- Computed Tomography Procedure
- Diffusing Alpha-emitter Radiation Therapy Radiation
- Docetaxel Drug
- Intensity-Modulated Proton Therapy Procedure
- Intensity-Modulated Radiation Therapy Radiation
- Magnetic Resonance Imaging Procedure
- Modified Barium Swallow Study Procedure
- Observation Activity Other
- Positron Emission Tomography Procedure
- Quality-of-Life Assessment Other
- Questionnaire Other
Procedure · Drug · Radiation + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 20, 2023 (Actual)
- Primary completion
- Sep 6, 2029 (Estimated)
- Completion
- Sep 6, 2029 (Estimated)
- Last update posted
- Oct 1, 2026
2023 – 2029
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | Recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | Recruiting |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05541016, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05541016 live on ClinicalTrials.gov.