Overview
This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected p16+ 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.
Description
This is a single-arm, phase II study of dose-reduced, adjuvant radiotherapy (10 treatments over 2 weeks) for patients with p16+ oropharyngeal squamous cell carcinoma after completion of transoral robotic resection (TORS) and selective neck dissection (SND). Selected patients will be required to have measurable preoperative circulating tumor human papillomavirus DNA (ctHPVDNA) and undetectable postoperative (pre-radiotherapy) ctHPVDNA. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group (AVOID trial, Swisher-McClure et al. 2020) and found to be safe and effective.
Eligibility
Inclusion Criteria:
- Patients > 18 years old
- Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry
- Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 7th Ed)
- Pathologic N0, N1, N2a, N2b, or N2c disease (per AJCC 7th Ed), with < 5 positive lymph nodes
- Detectable preoperative plasma ctHPVDNA (copy number of > 200 copies/mL)
- Undetectable postoperative plasma ctHPVDNA
- ECOG Performance Status 0-1
Exclusion Criteria:
- Prior radiation therapy to the head and neck
- Presence of T4 disease
- Presence of N3 neck disease (per AJCC 7th Ed.)
- ≥ 5 positive lymph nodes
- 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.