Shortened Course Adjuvant Radiotherapy Following TORS

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05714657
• Collaborator: (none)
• Enrollment: 104
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 27
• Patients Per Site: 34.7
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Oropharyngeal Squamous Cell Carcinoma	Radiation: adjuvant radiotherapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 104 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for p16+ Oropharyngeal Squamous Cell Carcinoma
• Actual Study Start Date: Jan 30, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Apr 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Locoregional control [2 years]

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

Secondary Outcome Measures

1. Progression free survival [2 Years]

   To determine progression free survival (any progression)

2. Metastasis free survival [2 years]

   To determine metastasis free survival (any distant metastasis)

3. Overall survival [2 years]

   To determine overall survival (alive or not)

4. Dysphagia, as measured by patient-reported outcome [2 years]

   To determine patient-reported quality of life (dysphagia) after completion of treatment, as assessed by the MDADI validated questionnaire

5. Quality of life, as measured by patient-reported outcome [2 years]

   To determine patient-reported quality of life (symptoms) after completion of treatment, as assessed by the MDASI-HN validated questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
3	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Alexander Lin, MD, Abramson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT05714657
• Other Study ID Numbers: UPCC 06322; 850926
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Feb 6, 2023