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.

NCT06915038

ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

Recruiting
NAAges 18+InterventionalTreatment
Indiana University
~120 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:NavDxAdjuvant Radiation 30 GrayAdjuvant Radiation 40 Gray

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease Free Survival
Measured over Up to 24 months post initial surgery
Squamous Cell Carcinoma of Oropharynx
HPV Positive Cancer
Throat Cancer
Tonsil Cancer
2 sites across 1 states
Indiana2
  • Michael Sim, MD · PRINCIPAL_INVESTIGATOR · Indiana University Melvin and Bren Simon Comprehensive Cancer Center

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Eligibility criteria

Inclusion

Subjects ≥ 18 years old at the time of informed consent.
Ability to provide written informed consent and HIPAA authorization.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).
Histopathologically confirmed squamous cell carcinoma.
Detectable ctHPVDNA from blood samples collected prior to treatment.
Resectable and accessible tumor with high probability of achieving negative margins.
Smokers and non-smokers included.
Tumor stage (AJCC 8th edition): T1 or T2, and select T3 tumors that are mobile and do not invade the larynx.
Nodal stage (AJCC 8th edition): N0, N1 or N2.
HPV+ tumor, as determined by p16, in-situ hybridization, real-time polymerase chain reaction, or ctHPVDNA.

Exclusion

Serious medical condition preventing general anesthesia for surgery.
History of previous head and neck radiation or previous head and neck cancer within 3 years.
Distant metastatic disease present.
Subjects with synchronous HPV+ oropharynx primaries
Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study.
Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test on the day of surgery. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
  • Disease Free SurvivalUp to 24 months post initial surgery

    Time from surgery to first disease recurrence or death from any cause