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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
Must not have
Distant metastatic disease
History of active cancer other than non-melanoma skin cancer within the last 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to distant parts of my body.
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I have not had any cancer except for non-melanoma skin cancer in the past 5 years.
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I have had radiation therapy to my head or neck.
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I cannot undergo radiation therapy due to health reasons.
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I cannot undergo PET/CT scans due to health reasons.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival
Secondary study objectives
Acute adverse events
Long term adverse events
distant disease-free survival
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,452 Previous Clinical Trials
2,971,656 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
~47 spots leftby Apr 2027
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