Treatment (reduced dose radiation therapy) for Oropharyngeal HPV-Positive Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Emory University Midtown Hospital, Atlanta, GA
Oropharyngeal HPV-Positive Squamous Cell Carcinoma+3 More
Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial tests whether reduced dose radiation therapy after transoral robotic surgery works in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer. HPV positive oropharyngeal cancer has a better prognosis than oropharyngeal cancer not caused by HPV. A standard of care treatment for HPV positive oropharyngeal cancer is transoral robotic surgery followed by radiation therapy. However, this treatment is associated with many long-term side effects including difficulty swallowing. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving reduced dose radiation therapy after transoral robotic surgery may improve swallowing outcomes and quality of life compared to standard of care dose radiation therapy after transoral robotic surgery.

Eligible Conditions

  • Oropharyngeal HPV-Positive Squamous Cell Carcinoma
  • Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Oropharyngeal HPV-Positive Squamous Cell Carcinoma

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: At 1 year post surgery

Year 1
Swallowing Function Mean
Swallowing Function T-Test
At 2 years
Locoregional Control (LRC)- Two Year
Quality of Life (QoL) - European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L)
Quality of Life (QoL) - MD Anderson Symptom Inventory
Quality of Life (QoL) - Michigan Xerostomia
At 6 months
Locoregional Control (LRC)- Six Month
Month 24
Overall Survival (OS)
Month 24
Progression-Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Oropharyngeal HPV-Positive Squamous Cell Carcinoma

Trial Design

1 Treatment Group

Treatment (reduced dose radiation therapy)
1 of 1
Experimental Treatment

33 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (reduced dose radiation therapy) · No Placebo Group · Phase 2

Treatment (reduced dose radiation therapy)
Radiation
Experimental Group · 1 Intervention: Radiation Therapy · Intervention Types: Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2005
Completed Phase 3
~7080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 year post surgery

Trial Background

James Bates, Principal Investigator
Principal Investigator
Emory University
Closest Location: Emory University Midtown Hospital · Atlanta, GA
Photo of Atlanta  1Photo of Atlanta  2Photo of Atlanta  3
2014First Recorded Clinical Trial
1 TrialsResearching Oropharyngeal HPV-Positive Squamous Cell Carcinoma
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a positive HPV test.
You have a T1-2, N0-1, cM0 disease.
You have a diagnosis of HPV-associated squamous cell carcinoma of the oropharynx.
Patients with HPV positive squamous cell carcinoma of an unknown primary of the head and neck presumed to be of oropharyngeal origin who have undergone ipsilateral palatine and lingual tonsillectomies.
You have a positive ctHPVDNA titer prior to surgery.
You have a minimum of 10 pack-years of smoking history.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.