Actively Recruiting
De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
Led by Mayo Clinic · Updated on 2026-05-12
455
Participants Needed
3
Research Sites
336 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official 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...
- Age 18 years or older
- Histologically confirmed squamous cell carcinoma of the oropharynx
- Planned gross total surgical resection with curative intent and at least unilateral neck dissection or chemoradiotherapy with cisplatin
- No distant metastases within 16 weeks prior to registration (confirmed by chest CT or PET/CT)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Negative pregnancy test within 7 days prior to registration for women of childbearing potential
- Ability to complete questionnaires independently or with assistance
- Willing to provide informed consent
- Willing to return to the enrolling institution for follow-up during active monitoring
- Willing to provide blood samples for correlative 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
- Severe systemic illnesses or concurrent diseases that interfere with safety assessment
- Immunocompromised patients or known HIV positive
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting compliance
- Receiving other investigational treatments for primary cancer
- Other active malignancies within 5 years except certain skin, cervical, prostate, or endometrial cancers without ongoing treatment
- 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 or substances that interfere with treatment (e.g., strong CYP3A4 inhibitors)
- Severe pre-existing ototoxicity or neuropathy precluding cisplatin use
- Tumor classified as cT4 primary
- Low risk patients with T1 or T2 tumors with lymph nodes less than 3 cm and no intermediate or high-risk factors withdrawn from study
- Patients both HPV negative and p16 negative withdrawn from study
- Patients with HPV non-16 type or low blood detectability of tumor tissue modified viral DNA excluded from de-escalation groups
- Patients with unknown primaries but suspected HPV-associated adenopathy must have identifiable primary tumor for Group 4
- All primary treatments performed at enrolling institution
AI-Screening
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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
CONTACT
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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