Status:
RECRUITING
ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
Lead Sponsor:
Indiana University
Conditions:
Squamous Cell Carcinoma of Oropharynx
HPV Positive Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 tr...
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 huma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06915038
Start Date
June 11 2025
End Date
December 1 2028
Last Update
July 31 2025
Active Locations (2)
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1
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States, 46032
2
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202