OPSCC N0 Nodal Control With Reduced IMRT

Not Applicable

Terminated

• Conditions: Oropharyngeal Squamous Cell Carcinoma (OPSCCA); HPV (Human Papillomavirus)-Associated
• Interventions: Radiation: 39.6 Gy radiation

• Registration Number: NCT01891695
• Lead Sponsor: Paul W. Read, MD

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-03
• Study Start: 2013-10
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Results First Submitted: 2021-06-17
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-20
• Last Update Submitted: 2022-09-20
• Results First Posted: 2022-10-12
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reduced Intensity Radiation	39.6 Gy radiation	39.6 Gy radiation to clinically uninvolved cervical lymphatics

Primary Outcome Measures

Name	Time	Method
N0 Nodal Control Rate	Up to 3 years post treatment	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)

Secondary Outcome Measures

Name	Time	Method
Dose Volume Histograms (DVH)	Up to 3 years post treatment	Comparison of DVH of treatment plans between patients receiving 39.6 Gy versus the standard dose of 50 Gy to the clinically uninvolved neck
Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck	Up to 3 years post treatment	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.
Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck	Up to 3 years post treatment	Patient status reviewed and confirmed through Neck CT and PET scans at follow up time points throughout trial

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States