ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

Not Applicable

Not yet recruiting

• Conditions: Squamous Cell Carcinoma of Oropharynx; HPV Positive Cancer; Tonsil Cancer; Throat Cancer

• Registration Number: NCT06915038
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

Oropharyngeal squamous cell carcinoma (OPSCC), commonly known as throat cancer or tonsil cancer, has seen a dramatic rise in incidence over the last twenty years due to the increased incidence of human papillomavirus-positive (HPV) infection and \* malignancy within the oropharynx.

The prevailing treatment philosophy within head and neck oncology is that deintensifying treatment could still provide equivalent oncologic outcomes, while further lowering toxicity profiles and improving functional outcomes to minimize the morbidity incurred by patients.

The next frontier in the treatment of HPV+ OPSCC, then, is the potential use of ctHPVDNA in the treatment personalization. Patients could be stratified into risk categories based on their ctHPVDNA levels, and in turn, receive a tailored treatment intensity accordingly.

The goal of this research study is to see if de-intensifying (stopping or scaling back) treatment still provides the same, or perhaps even better, results when compared to standard treatment when using your ctHPVDNA test results as a guide for your treatment.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-07
• Last Update Posted: 2025-04-07
• Study Start: 2025-05
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Disease Free Survival	Up to 24 months post initial surgery	Time from surgery to first disease recurrence or death from any cause

Secondary Outcome Measures

Name	Time	Method
Local-reginal Control	Up to 24 months post initial surgery	Number of subjects with no recurrence at primary oropharyngeal site or in the neck nodal basins
Overall Survival	Up to 24 months post initial surgery	Time from surgery to death from any cause
Distant metastasis rates	Up to 24 months post initial surgery	Assessed by tissue diagnosis or radiographically of recurrent disease at sites away from the primary tumor and neck nodal basins
Adverse Events	up to 6 months post initial surgery	Number of subjects that experience adverse events, grades 1-5, as assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) version 5.0
Swallowing-related Quality Of Life	3 months, 6 months, 12 months, and 24 months post initial surgery	Assessed using MD Anderson Dysphagia Inventory (MDADI)
Gastrostomy tube dependence rates	12 and 24 months post intial surgery	Assessed by confirmation of feeding tube in-situ in subject and being utilized for nutrition

Trial Locations

Locations (2)

IU Health Joe and Shelly Schwarz Cancer Center; 🇺🇸 Carmel, Indiana, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States