ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
This study is looking at a new way to guide treatment for HPV-positive oropharyngeal squamous cell carcinoma (throat or tonsil cancer). It uses a blood test called NavDx, which detects circulating tumor HPV DNA (ctHPVDNA). After surgery, your ctHPVDNA levels, along with other tests, will help doctors decide if you can receive a deintensified (lower dose) radiation treatment (Adjuvant Radiation 30 Gray) or if you need standard radiation (Adjuvant Radiation 40 Gray). The main goal is to see if this personalized approach can lead to similar disease-free survival for up to 24 months, while potentially reducing side effects. You may be eligible if you are 18 or older with HPV-positive oropharyngeal cancer and have a good performance status. The study plans to enroll 120 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments as part of the research. It is a prospective phase II trial, designed to assess the efficacy and feasibility of treatment deintensification.
- What's involved
- You would undergo surgery and neck dissection, followed by blood tests for ctHPVDNA, and then receive either 30 Gray or 40 Gray radiation treatment based on your test results and other factors. You will be followed for up to 24 months after your initial surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 24 months post initial surgery to measure disease-free survival.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Michael Sim, MD · PRINCIPAL_INVESTIGATOR · Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Disease Free SurvivalUp to 24 months post initial surgery
Time from surgery to first disease recurrence or death from any cause