Shortened Course Adjuvant Radiotherapy Following TORS

RECRUITING

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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.

Conditions:

🦠 HPV-Associated Oropharyngeal Squamous Cell Carcinoma

🗓️ Study Start (Actual) 30 January 2023

🗓️ Primary Completion (Estimated) 31 December 2025

✅ Study Completion (Estimated) 30 April 2026

👥 Enrollment (Estimated) 104

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Lancaster, Pennsylvania, United States

📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 3 August 2022
First Submitted that Met QC Criteria 2 February 2023
First Posted 6 February 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 3 July 2024
Last Update Posted 5 July 2024
Last Verified July 2024