Actively Recruiting
DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy
Led by Mayo Clinic · Updated on 2026-05-12
455
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying human papillomavirus (HPV) positive oropharyngeal squamous cell cancers to evaluate if a blood-based biomarker test, using the NavDx device, can guide decisions on radiation and chemotherapy treatments. This Phase II trial aims to balance reducing treatment side effects with lowering the chances of cancer recurrence. The study involves patients with head and neck cancers who undergo standard treatments like surgery, radiation, and chemotherapy, monitoring how the biomarker may help in early detection and treatment adjustment. Participants are assigned to one of four groups based on their risk and treatment plans. Group 1 follows observation after surgery with regular scans and swallow studies. Group 2 receives diffusing alpha-emitter radiation therapy (DART) with docetaxel alongside scheduled imaging and sample collections. Group 3 undergoes intensity-modulated radiation therapy (IMRT) or proton therapy (IMPT) with or without cisplatin chemotherapy. Group 4 gets IMRT or IMPT with concurrent cisplatin, with treatment intensity adjusted by biomarker response. All groups have detailed schedules for scans, swallow studies, and blood and saliva sample collections at various timepoints. During the study, participants undergo multiple evaluations including imaging (CT, PET/CT, MRI), modified barium swallow studies, and blood and saliva collections for NavDx biomarker testing. Follow-up visits occur frequently after treatment completion, with monitoring extending up to five years for progression-free survival, disease recurrence, survival rates, patient-reported outcomes, treatment side effects, functional outcomes, return to work, and cost assessments. This thorough monitoring aims to understand treatment impacts and the biomarker's role in guiding therapy and detecting recurrence early.
CONDITIONS
Brief Title
De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Age 18 years or older
- Histological confirmation of squamous cell carcinoma originating from or suspected to be from the oropharynx
- Plan for gross total surgical resection via transoral surgery with curative intent and at least unilateral neck dissection OR chemoradiotherapy with cisplatin
- No distant metastases on chest CT or PET/CT within 16 weeks prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Negative pregnancy test within 7 days prior to registration for women of childbearing potential
- Ability to complete questionnaires independently or with assistance
- Willingness to return to the enrolling institution for follow-up during active monitoring
- Willingness to provide blood samples for research including NavDx testing
You will not qualify if you...
- Pregnant or nursing women
- Men or women of childbearing potential unwilling to use adequate contraception
- Co-morbid systemic illnesses or severe concurrent diseases that interfere with safety or assessment
- Immunocompromised patients or known HIV positive
- Uncontrolled illnesses such as active infection, congestive heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Receiving other investigational agents for the primary cancer
- Other active malignancy within 5 years except certain skin, cervical, prostate, or localized endometrial cancers
- Prior radiation therapy to the affected site
- Prior systemic chemotherapy in the last 5 years
- Contraindications to radiation therapy
- History of allergic reaction to docetaxel
- Use of medications interfering with treatment, such as strong CYP3A4 inhibitors
- Severe pre-existing ototoxicity or neuropathy preventing cisplatin use
- cT4 primary tumor
- Patients with no intermediate risk factors after surgery or HPV negative/p16 negative will be withdrawn
- Patients with HPV non-16 type or low tumor tissue modified viral load (TTMV) may not be eligible for de-escalation in certain groups
- Patients with unknown primaries but suspected HPV-associated carcinoma may be withdrawn if no tumor identified
- All treatment performed at enrolling institution
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable, prior to further treatment or observation
Participants undergo standard of care surgery including gross total surgical resection via transoral surgery with curative intent and at least unilateral neck dissection before starting further treatment or observation.
1 surgery visit
Duration - Up to 8 weeks for DART or up to 6 weeks for IMRT/IMPT depending on group
Participants receive treatment based on assigned group, including observation, radiation therapy (DART, IMRT, or IMPT), and chemotherapy with docetaxel or cisplatin as applicable, continuing in absence of disease progression or unacceptable toxicity.
Daily visits Monday to Friday for radiation fractions; additional visits for chemotherapy infusions as scheduled
Duration - Up to 5 years
Participants are monitored with periodic imaging, specimen collections, and functional assessments to evaluate disease status, treatment outcomes, and side effects.
Visits every 3 months for 2 years, every 6 months for year 3, then annually for years 4 and 5
Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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