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Proton Beam Therapy

Reduced Radiation Therapy for Oropharyngeal Cancer

N/A
Recruiting
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck
Patients must be ≥ 18 years of age on the day of signing informed consent
Must not have
Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma
Lymphovascular space invasion at primary site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial aims to see if patients with intermediate-risk HPV/p16(+) oropharyngeal cancer and minimal smoking history can be treated with a lower dose of radiation and a smaller radiation field than

Who is the study for?
This trial is for individuals with HPV-positive oropharyngeal cancer who have had Transoral Robotic Surgery and are light smokers or non-smokers. They should be intermediate-risk patients, meaning their condition isn't the most severe.
What is being tested?
The study tests if a lower dose of radiation therapy (50Gy in 25 fractions) to a smaller area (neck only, excluding tumor's original site in the oropharynx) works as well as standard treatments for these cancer patients.
What are the potential side effects?
Radiation therapy may cause side effects like skin irritation at the treatment site, fatigue, dry mouth, difficulty swallowing, changes in taste, and potential thyroid issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had surgery to remove my cancer through the mouth and also had surgery on the neck on the same side.
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I am 18 years old or older.
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My throat cancer is linked to HPV or has p16 protein.
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My throat cancer is in an early stage with limited spread to nearby nodes.
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I have been mostly able to care for myself in the past 2 months.
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I haven't smoked for at least 6 months and have a smoking history of 15 pack-years or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have ECE but no biopsy showing squamous cell carcinoma in neck lymph nodes.
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My cancer has spread into the lymph or blood vessels at the original site.
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My cancer has spread along the nerves at the original site.
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I have had cancer in the nodes behind my throat.
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I have cancer that has not been surgically removed.
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My cancer has spread to the muscles in my neck.
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I had surgery for my condition that involved opening my jaw or throat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival
Secondary study objectives
DMFS
Local Control
OS
+3 more
Other study objectives
translation

Trial Design

1Treatment groups
Experimental Treatment
Group I: treatment armExperimental Treatment1 Intervention
50Gy in 25 fractions to the neck at risk for tumor recurrence, excluding the primary site
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
346 Previous Clinical Trials
137,180 Total Patients Enrolled
MedStar Georgetown University HospitalOTHER
5 Previous Clinical Trials
22,839 Total Patients Enrolled
~9 spots leftby Dec 2026
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