Shortened Course Adjuvant Radiotherapy Following TORS

Oropharyngeal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714657
• Other study ID #: UPCC 06322
• Secondary ID: 850926
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Alexander Lin, MD
• Phone: 2156623198
• Email: Alexander.Lin2[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Radiation:
• adjuvant radiotherapy
Shortened Course Adjuvant Radiotherapy Following TORS

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional control	To determine whether disease recurs locally (at primary site) or in the regionally in the nodes of the neck	2 years
Secondary	Progression free survival	To determine progression free survival (any progression)	2 Years
Secondary	Metastasis free survival	To determine metastasis free survival (any distant metastasis)	2 years
Secondary	Overall survival	To determine overall survival (alive or not)	2 years
Secondary	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
Secondary	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