ACTIVE_NOT_RECRUITING

Shortened Course Adjuvant Radiotherapy Following TORS

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Conditions

HPV-Associated Oropharyngeal Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-01-30
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05714657

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients ≥ 18 years old
  2. * Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry or HPV-positive by In-Situ Hybridization
  3. * Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 8th Ed)
  4. * Pathologic N0-N1 disease (per AJCC 8th Ed)
  5. * Preoperative plasma ctHPVDNA of ≥ 50 copies/mL
  6. * Undetectable postoperative plasma ctHPVDNA
  7. * ECOG Performance Status 0-1
  1. * Prior external beam radiation therapy to the head and neck
  2. * Presence of T4 disease
  3. * ≥ 5 positive lymph nodes (which is pathologic N2 disease, per AJCC 8th edition)
  4. * Presence of distant metastatic disease
  5. * 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.

Contacts and Locations

Principal Investigator

Alexander Lin, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Lancaster General Hospital
Lancaster, Pennsylvania, 17604
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

  • Alexander Lin, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

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

Study Start Date2023-01-30
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2023-01-30
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • HPV-Associated Oropharyngeal Squamous Cell Carcinoma