Using blood HPV DNA to guide treatment in HPV-positive throat cancer
Circulating Tumor HPV DNA Driven Adjuvant Treatment Deintensification After Transoral Surgery for HPV-Positive Squamous Cell Carcinoma of the Oropharynx
This trial tests whether a blood HPV DNA test can let doctors safely reduce post-surgery radiation for people with HPV-positive throat cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Carmel, Indiana and 1 other locations) |
| Trial ID | NCT06915038 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with resectable HPV-positive oropharyngeal squamous cell carcinoma (T1–T2, selected T3; N0–N2) who have detectable pre-treatment ctHPVDNA and are undergoing transoral surgery with neck dissection are ideal candidates.
Not a fit: Patients with unresectable or very advanced disease (for example T4 or laryngeal invasion), those not eligible for transoral surgery, or those without detectable preoperative ctHPVDNA are unlikely to benefit from deintensified adjuvant therapy in this protocol.
Why it matters
Potential benefit: If successful, this approach could lower radiation-related side effects and improve swallowing and quality of life while maintaining cancer control.
How similar studies have performed: Prior studies show ctHPVDNA is a sensitive marker for HPV-positive head and neck cancers and some deintensification trials have reported promising functional outcomes, but ctDNA-guided deintensification remains a relatively new approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Mobile neck nodes on physical exam if N positive. * 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 this trial is running
Carmel, Indiana and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.