Shortened Course Adjuvant Radiotherapy Following TORS

NCT05714657 | Active Not Recruiting Phase 2

• 2 other identifiers: UPCC 06322852738
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Locoregional control

  To determine whether disease recurs locally (at primary site) or in regionally in the nodes of the neck

  2 years

Secondary Outcomes (6)

• Progression-free survival

  2 Years

• Metastasis-free survival

  2 years

• Overall survival

  2 years

• Differences in toxicity between patients receiving IMRT and patients receiving PBT

  2 years

• Patient-Reported Quality of Life using MDASI-HN

  2 years

Study Arms (1)

Shortened Course Adjuvant Radiotherapy

EXPERIMENTAL

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. In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered.

Radiation: Shortened Course Adjuvant Radiotherapy Following TORS

Interventions

Shortened Course Adjuvant Radiotherapy Following TORS RADIATION

Shortened Course Adjuvant Radiotherapy Following TORS

Shortened Course Adjuvant Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (3)

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

• Alexander Lin, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: February 6, 2023
• Study Start: January 30, 2023
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)