OPSCC N0 Nodal Control With Reduced IMRT

A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx

The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering.

The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.

Study Overview

• Status: Terminated
• Conditions: Oropharyngeal Squamous Cell Carcinoma (OPSCCA); HPV (Human Papillomavirus)-Associated
• Intervention / Treatment: Radiation: 39.6 Gy radiation

Detailed Description

A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient must be clinically referred for radiation for stage I-IVb OPSCCA
• tumor must be HPV-associated p16+
• patient must be able to lie flat and tolerate immobilization systems

Exclusion Criteria:

• patients may not be receiving any investigational agents
• prior radiation to head and neck
• any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years
• any major medical, psychiatric, or neurologic illness
• pregnant or breastfeeding women

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: Reduced Intensity Radiation; 39.6 Gy radiation to clinically uninvolved cervical lymphatics	Radiation: 39.6 Gy radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
N0 Nodal Control Rate	Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA)	Up to 3 years post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck	Evaluated safety and tolerability of treatment of p16+ OPSCCA by overall incidence of adverse events, incidence of acute and late toxicities and subject-rated quality of life assessments.	Up to 3 years post treatment
Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck	Patient status reviewed and confirmed through Neck CT and PET scans at follow up time points throughout trial	Up to 3 years post treatment
Dose Volume Histograms (DVH)	Comparison of DVH of treatment plans between patients receiving 39.6 Gy versus the standard dose of 50 Gy to the clinically uninvolved neck	Up to 3 years post treatment

Collaborators and Investigators

• Sponsor: Paul W. Read, MD
• Investigators: Principal Investigator: Paul W Read, MD, PhD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: June 28, 2013
• First Posted (Estimate): July 3, 2013

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

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: 16766