Shortened Course Adjuvant Radiotherapy Following TORS
United States104 participantsStarted 2023-01-30
Plain-language summary
This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected HPV-Associated OPSCC patients receiving adjuvant radiation after TORS and neck dissection. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.
Who can participate
Age range18 Years
SexALL
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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.