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Radiation

Reduced-Dose Radiation Therapy for Oropharyngeal Cancer

Phase 2

Recruiting

Led By James E Bates, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathology must demonstrate at least one of the following intermediate risk factors: Close margin (1 - 4 mm), Perineural invasion, Lymphovascular space invasion, 2 - 4 positive lymph nodes without extranodal extension (ENE), A single positive lymph node > 3 cm in size, without ENE

Has diagnosis of HPV-associated squamous cell carcinoma of the oropharynx

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Patients with a prior history of malignancy in the last two years (excluding non-melanomatous skin cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year post surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether reducing the amount of radiation therapy given after surgery for HPV-positive oropharyngeal cancer will improve swallowing outcomes and quality of life.

Who is the study for?

Adults with HPV-positive oropharyngeal cancer who've had surgery and limited smoking history can join this trial. They must have a life expectancy over 12 weeks, be in good enough health to perform daily activities, and agree to use contraception. Those with extensive cancer spread, recent other cancers, or severe illnesses are excluded.

What is being tested?

The trial is testing if lower doses of radiation therapy after robotic surgery improve swallowing and quality of life for patients with HPV-positive throat cancer compared to the standard higher doses usually given after such surgeries.

What are the potential side effects?

Reduced dose radiation may lead to fewer long-term side effects than standard treatment; however, potential side effects include skin changes, fatigue, dry mouth/throat issues affecting swallowing and taste sensation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has one of the following: close margin, perineural invasion, lymphovascular invasion, 2-4 positive lymph nodes without ENE, or a single lymph node larger than 3 cm without ENE.

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I have been diagnosed with a type of throat cancer linked to HPV.

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I have smoked 10 or fewer packs of cigarettes a year.

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I am 18 years old or older.

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I can take care of myself but might not be able to do active work.

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My cancer is HPV positive.

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My cancer is in early stages and hasn't spread far.

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I had robotic surgery for throat cancer and neck dissection at Emory.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have not had cancer, except for non-dangerous skin cancer, in the last 2 years.

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I haven't had major heart or blood vessel problems in the last 3 months.

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I haven't had chemotherapy or radiotherapy in the last 4 weeks and have no lasting side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Swallowing Function Mean

Swallowing Function T-Test

Secondary study objectives

Locoregional Control (LRC)- Six Month

Locoregional Control (LRC)- Two Year

Overall Survival (OS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (reduced dose radiation therapy)Experimental Treatment1 Intervention

Patients who are ctHPVDNA negative after surgery undergo reduced dose radiation therapy for 3 weeks (15 treatments). Patients who are ctHPVDNA positive after surgery undergo standard of care radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 12Eligibility criteria met