NCT06915038Recruiting
ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
Circulating Tumor HPV DNA Driven Adjuvant Treatment Deintensification After Transoral Surgery for HPV-Positive Squamous Cell Carcinoma of the Oropharynx
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 1 Apr 2025
- Start date
- 11 Jun 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Indiana University
- Diseases
- Head and neck cancer
- NCT number
- NCT06915038
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 11 Jun 2025 to the primary completion date, Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous head and neck radiation or previous head and neck cancer within 3 years.
- 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:
- Has undergone a hysterectomy or bilateral oophorectomy; or
- Has been naturally amenorrheic for at least 12 consecutive months.
Other illness
- Serious medical condition preventing general anesthesia for surgery.
- Distant metastatic disease present.
- 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.
Other
- Subjects with synchronous HPV+ oropharynx primaries
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IU Health Joe and Shelly Schwarz Cancer Center Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.