Shortened Course Adjuvant Radiotherapy Following TORS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma

Conditions
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Oropharyngeal Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: adjuvant radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy<br>The volume treated to the regional lymphatics will be according to the characteristics of the primary site and involved lymph nodes. The dose of radiotherapy delivered will be 30 Gy, over the course of 10 treatments (5 daily treatments/week). Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol.1 In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered. | Radiation: adjuvant radiotherapy<br>* Shortened Course Adjuvant Radiotherapy Following TORS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control | To determine whether disease recurs locally (at primary site) or in the regionally in the nodes of the neck | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | To determine progression free survival (any progression) | 2 Years | 
| Metastasis free survival | To determine metastasis free survival (any distant metastasis) | 2 years | 
| Overall survival | To determine overall survival (alive or not) | 2 years | 
| Dysphagia, as measured by patient-reported outcome | To determine patient-reported quality of life (dysphagia) after completion of treatment, as assessed by the MDADI validated questionnaire | 2 years | 
| Quality of life, as measured by patient-reported outcome | To determine patient-reported quality of life (symptoms) after completion of treatment, as assessed by the MDASI-HN validated questionnaire | 2 years |