NCT05541016 · Mayo Clinic
De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
What this study is about
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.
View original scientific description
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.
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 Activity
Undergo observation
PROCEDURE
Positron Emission Tomography
Undergo PET scan
OTHER
Quality-of-Life Assessment
Ancillary studies
OTHER
Questionnaire
Ancillary studies
Primary outcome measures
Progression-free survival (PFS)
Time frame: From registration to the first of either disease progression/recurrence or death, assessed up to 5 years
Progression-free survival (PFS), the time from treatment initiation until disease progression or worsening. PFS at specific timepoints will be estimated using Kaplan-Meier methodology.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- PRE-REGISTRATION (optional): Provide written informed consent
- Age \>= 18 years
- Histological confirmation of p16+ OPSCC or HPV(+) OPSCC
- Plan for gross total surgical resection via trans oral surgery with curative intent and at least unilateral neck dissection OR chemoradiotherapy with cisplatin. Note: The patient must be cisplatin eligible even if an alternate is used due to drug shortage
- Absence of distant metastases on standard diagnostic work-up =\< 16 weeks prior to registration. (Chest CT or PET/CT)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 1
- Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Willing to provide blood samples for correlative research purp
Where
- Scottsdale, Arizona
- Jacksonville, Florida
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations