Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT05714657
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years old
* Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry or HPV-positive by In-Situ Hybridization
* Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 8th Ed)
* Pathologic N0-N1 disease (per AJCC 8th Ed)
* Preoperative plasma ctHPVDNA of ≥ 50 copies/mL
* Undetectable postoperative plasma ctHPVDNA
* ECOG Performance Status 0-1
Exclusion Criteria:
* Prior external beam radiation therapy to the head and neck
* Presence of T4 disease
* ≥ 5 positive lymph nodes (which is pathologic N2 disease, per AJCC 8th edition)
* Presence of distant metastatic disease
* Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05714657
Study Brief:
Protocol Section:
NCT05714657