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Radiation

Reduced Radiation Therapy for Oropharyngeal Cancer

N/A

Recruiting

Led By David Brizel, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Zubrod/ECOG score of 0-1

Stage I-III (AJCC 8th edition) with plan for concurrent chemotherapy per standard of care treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will use PET scans to see how well patients respond to radiation therapy for HPV-related throat cancer, in order to decide if patients can have a lower dose of radiation.

Who is the study for?

This trial is for adults over 18 with HPV-related oropharyngeal cancer, confirmed by specific tests, who haven't had chemotherapy for their current diagnosis. They should be in good physical condition with minimal weight loss recently and have early to mid-stage cancer treatable with chemo.Check my eligibility

What is being tested?

The study uses advanced imaging (FDG-PET/CT scans) during standard radiation therapy to see if some patients can receive lower doses of radiation safely. It aims to find out if reducing the dose after a positive response affects treatment outcomes.See study design

What are the potential side effects?

Potential side effects include those typically associated with radiation therapy such as skin irritation, fatigue, dry mouth, difficulty swallowing, and changes in taste. The PET/CT scan procedure itself has minimal risks like exposure to low levels of radiation.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My cancer is stage I-III and I will receive chemotherapy as standard care.

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I am 18 years old or older.

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My throat cancer is HPV-positive.

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I have not had chemotherapy for my current cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression-free survival

Secondary outcome measures

Acute adverse events

Long term adverse events

distant disease-free survival

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interim PET-CT with dose de-escalationExperimental Treatment2 Interventions

Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.

Group II: Interim PET-CT with standard radiationActive Control2 Interventions

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,366 Total Patients Enrolled

David Brizel, MDPrincipal InvestigatorDUHS

Yvonne Mowery, MD PhDPrincipal InvestigatorDUHS

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

De-escalated radiation dose (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04667585 — N/A

Oropharyngeal Cancer Research Study Groups: Interim PET-CT with standard radiation, Interim PET-CT with dose de-escalation

Oropharyngeal Cancer Clinical Trial 2023: De-escalated radiation dose Highlights & Side Effects. Trial Name: NCT04667585 — N/A

De-escalated radiation dose (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04667585 — N/A

Frequently Asked Questions

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

Is this research study currently open to volunteers?

"This clinical trial is actively seeking participants, as per the latest update on 8/10/2022. The research project was originally posted to clinicaltrials.gov on 4/12/2021."

Answered by AI

How many participants have consented to participate in this experiment?

"Affirmative. Clinicaltrials.gov verifies that this research, initially posted on April 12th 2021, is actively recruiting participants. The investigators are looking for 120 individuals from two different sites to take part in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx

2021. "Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04667585.