ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

Launched by INDIANA UNIVERSITY · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to treating patients with HPV-positive squamous cell carcinoma of the oropharynx, which is a type of throat cancer. The study aims to see if measuring levels of HPV DNA in the blood (called ctHPVDNA) can help doctors determine if patients can safely receive less intensive treatment after surgery. Participants will undergo surgery to remove the tumor from their throat and will then be evaluated to see how well this treatment strategy works.

To be eligible for the trial, patients must be at least 18 years old, have a confirmed diagnosis of HPV-positive throat cancer, and have a tumor in a specific area of the throat that can be surgically removed with a good chance of achieving clear margins (meaning no cancer cells are left behind). The trial is open to both smokers and non-smokers, but those with serious health issues, a history of certain cancers, or other specific conditions may not qualify. As the study is not yet recruiting participants, those interested will need to wait until it officially begins.

Gender

ALL

Eligibility 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.