Using blood HPV DNA to guide treatment in HPV-positive throat cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective Phase II protocol uses ctHPVDNA (NavDx) measurements to guide adjuvant radiation deintensification after transoral surgery and neck dissection for HPV-positive oropharyngeal squamous cell carcinoma. Patients have pre- and post-operative blood tests and are stratified by ctHPVDNA levels to receive lower-dose adjuvant radiation (for example 30 or 40 Gy) when appropriate. The study will track recurrence rates, feasibility of the deintensified approach, and functional and toxicity outcomes compared with standard expectations. Enrollment is limited to adults with resectable T1-T2 and selected mobile T3 tumors and N0–N2 nodal status who have detectable pre-treatment ctHPVDNA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Pre-Surgery

* 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.

Post-Surgery

• Subjects with unknown primaries included if primary is definitively identified and resectable with negative margins or if the palatine and lingual tonsils are thoroughly resected and pathologically proven to be negative for a primary.

Exclusion Criteria:

* 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:

  1. Has undergone a hysterectomy or bilateral oophorectomy; or
  2. Has been naturally amenorrheic for at least 12 consecutive months.

Where it's running

• IU Health Joe and Shelly Schwarz Cancer Center
  Carmel, Indiana, United States Recruiting
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Michael Sim, MD — Indiana University Melvin and Bren Simon Comprehensive Cancer Center
• Study coordinator: Azeezat Yekinni
• Email: ayekinn@iu.edu
• Phone: 317-529-6883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.