De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnant women

Nursing women

Men or women of childbearing potential who are unwilling to employ adequate contraception

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Cisplatin
  • Computed Tomography
  • Diffusing Alpha-emitter Radiation Therapy
  • Docetaxel
  • Intensity-Modulated Proton Therapy
  • Intensity-Modulated Radiation Therapy
  • Magnetic Resonance Imaging
  • Modified Barium Swallow Study
  • Observation Activity
  • Positron Emission Tomography
  • Quality-of-Life Assessment
  • Questionnaire

Treatment groups

455 Participants
are divided into 4 treatment groups

Sponsors and collaborators