Shortened Course Adjuvant Radiotherapy Following TORS

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Shortened Course Adjuvant Radiotherapy Following TORS

Condition
HPV-Associated Oropharyngeal Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Lancaster

Lancaster General Hospital, Lancaster, Pennsylvania, United States, 17604

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Pennsylvania Hospital, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abramson Cancer Center at Penn Medicine,

Alexander Lin, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2026-04-30