OPSCC N0 Nodal Control With Reduced IMRT

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

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

Conditions
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Oropharyngeal Squamous Cell Carcinoma (OPSCCA), HPV (Human Papillomavirus)-Associated

Intervention / Treatment
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* Radiation: 39.6 Gy radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced Intensity Radiation<br>39.6 Gy radiation to clinically uninvolved cervical lymphatics | Radiation: 39.6 Gy radiation<br> <br> |

What is the study measuring?
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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 |