RecruitingNot ApplicableNCT06915038

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

Sponsor

Indiana University

Enrollment

120 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Throat Cancer Squamous Cell Carcinoma of Oropharynx HPV Positive Cancer Tonsil Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria15

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 Criteria8

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

Interventions

DIAGNOSTIC_TESTNavDx

NavDx is a clinically validated blood test to detect circulating tumor HPV DNA (ctHPVDNA). In this study, ctHPVDNA results, in conjuction with specimen analysis, will be used to assign post-surgical adjuvant treatment.

RADIATIONAdjuvant Radiation 30 Gray

If undetectable postoperative ctHPVDNA levels and five or more positive nodes, or confirmed extranodal extension (ENE) (greater than 2 mm) deintensified radiation treatment of 30 gray.

RADIATIONAdjuvant Radiation 40 Gray

If detectable postoperative ctHPVDNA, then reimage to evaluate for potentially operable disease, followed by appropriate surgery as indicated. If surgery is performed, repeat ctHPVDNA levels will be checked, and if then negative, subject will be placed in observation if N0 or N1 disease, and 30 Gy of radiation if N2 disease on final pathologic staging. If repeat ctHPVDNA level is positive, or shows no obvious operable disease, then subject will undergo 40 Gy of radiation.