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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year post surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Swallowing Function Mean

Swallowing Function T-Test

Secondary outcome measures

Locoregional Control (LRC)- Six Month

Locoregional Control (LRC)- Two Year

Overall Survival (OS)

+4 more

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,663 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,821 Total Patients Enrolled

2 Trials studying Oropharyngeal Carcinoma

152 Patients Enrolled for Oropharyngeal Carcinoma

James E Bates, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Media Library

Radiation Therapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05387915 — Phase 2

Oropharyngeal Carcinoma Research Study Groups: Treatment (reduced dose radiation therapy)

Oropharyngeal Carcinoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT05387915 — Phase 2

Radiation Therapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05387915 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this research endeavor attempting to fulfill?

"This clinical study seeks to quantify Swallowing Function using T-Tests over a one year postoperative period. Secondary objectives include evaluating Quality of Life (QoL) with the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L), Progression Free Survival through Response Evaluation Criteria in Solid Tumors(RECIST) 1.1, and QoL - Michigan Xerostomia questionnaires respectively. Comparisons will be made descriptively between this trial's two year PFS estimate and its 95% confidence interval against ECOG 3311 Arm B for historical context."

Answered by AI

Is there still availability for participants to join this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this experiment, which was first uploaded on June 6th 2022, is actively recruiting patients. A total of 33 participants must be recruited from two different medical sites."

Answered by AI

How many individuals are participating in this research effort?

"Affirmative. Clinicaltrials.gov renders evidence that this clinical trial is presently recruiting candidates, with the initial posting on June 6th 2022 and most recent change made on June 7th 2022. 33 individuals are required at two sites in order to fulfill their recruitment quota."

Answered by AI

Have any governmental entities sanctioned Radiation Therapy?

"Radiation Therapy is regarded as moderately safe, earning it a score of 2. This rating comes from Phase 2 trial results which indicate the treatment has been tested for safety but not efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biomarker-Driven Radiation Therapy Dose Reduction After Transoral Robotic Surgery for the Treatment of HPV-Positive Oropharyngeal Cancer

James Bates 2022. "Biomarker-Driven Radiation Therapy Dose Reduction After Transoral Robotic Surgery for the Treatment of HPV-Positive Oropharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05387915.