DART 2.0: ctHPV-DNA Informed De-Escalated Adjuvant and Definitive Radiation Therapy
Mayo Clinic
Summary
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.
Description
PRIMARY OBJECTIVES: I. To prospectively incorporate circulating tumor human papillomavirus deoxyribonucleic acid (ctHPVDNA) in combination with clinical and pathologic factors to appropriately select patients for treatment intensity. II. To demonstrate patients traditionally offered adjuvant radiation therapy (RT) but at low risk of treatment failure based on clinical pathologic and post op ctHPVDNA risk factors have an acceptable 1-year progression free survival (PFS) warranting further study. (Favorable Intermediate Risk \[GROUP 1\]) III. To demonstrate based on clinical, pathologic, and c…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PRE-REGISTRATION (optional): Provide written informed consent * Age \>= 18 years * Histological confirmation of squamous cell carcinoma originating from or suspected to be originating from the oropharynx * 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…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and saliva specimen collection for NavDx testing
- DrugCisplatin
Given IV
- ProcedureComputed Tomography
Undergo CT scan
- RadiationDiffusing Alpha-emitter Radiation Therapy
Undergo DART
- DrugDocetaxel
Given IV
- ProcedureIntensity-Modulated Proton Therapy
Undergo IMPT
- RadiationIntensity-Modulated Radiation Therapy
Locations (3)
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic in FloridaJacksonville, Florida
- Mayo Clinic in RochesterRochester, Minnesota