Shortened Course Adjuvant Radiotherapy Following TORS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oropharyngeal Squamous Cell Carcinoma
• Intervention / Treatment: Radiation: adjuvant radiotherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Lin, MD; Phone Number: 2156623198; Email: Alexander.Lin2@pennmedicine.upenn.edu
• Study Contact Backup: Name: Wencesley Paez, MD; Phone Number: 2156146086; Email: Wencesley.Paez@Pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Alexander Lin, MD; Phone Number: 855-216-0098
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center of the University of Pennsylvania
      • Contact: Alexander Lin, MD; Phone Number: 855-216-0098; Email: PennCancerTrials@emergingmed.com
      • Principal Investigator: Alexander Lin, MD
      • Contact: Lin
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Pennsylvania Hospital
      • Contact: Michelle Gentile, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiotherapy; 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; Shortened Course Adjuvant Radiotherapy Following TORS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Alexander Lin, MD, Abramson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: UPCC 06322; 850926 (Registry Identifier: Shortened Course Adjuvant Radiotherapy Following TORS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No