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Radiation

Radiotherapy Techniques for Oropharyngeal Cancer

N/A
Waitlist Available
Led By Colette Shen, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
T0-4, N0-3, M0 disease American Joint Committee on Cancer (AJCC 7th or 8th edition) of the oropharynx planned for definitive radiotherapy +/- chemotherapy
Age ≥ 18 years at the time of consent
Must not have
Prior history of radiation therapy to the head and neck
Patients with Sjogren's syndrome or baseline xerostomia (CTCAE > 0 for the question regarding dry mouth)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after completion of radiotherapy
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to reduce dry mouth in patients with oropharynx cancer undergoing radiation therapy. The study will use MRI to guide the definition of salivary gland ducts in order to spare them

Who is the study for?
This trial is for individuals with dry mouth due to radiation treatment for cancers in the throat or head and neck area. Participants must have a diagnosis of oropharyngeal cancer and be scheduled to receive radiotherapy.
What is being tested?
The study compares standard radiotherapy with an experimental approach that uses MRI to try sparing parts of the salivary glands during treatment, aiming to reduce dry mouth symptoms after therapy.
What are the potential side effects?
Standard radiotherapy can cause persistent dry mouth, changes in saliva secretion, pH level alterations, and potential discomfort. The new method's side effects are being studied but may include similar issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My throat cancer is at a stage where it can be treated with radiation, with or without chemotherapy.
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I am 18 years old or older.
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I can safely undergo an MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to my head or neck before.
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I have Sjogren's syndrome or I often have a very dry mouth.
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My cancer affects my salivary glands.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after completion of radiotherapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after completion of radiotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The difference in patient-reported xerostomia 6 months
Secondary study objectives
Parotid duct dose constraint
Saliva mass
The difference in patient-reported xerostomia 12 months
+1 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: Parotid DuctExperimental Treatment1 Intervention
Magnetic resonance images will be used to localize the parotid ducts and limit the radiation dose to these structures to less than or equal to 14 Gy.
Group II: Mean ParotidActive Control1 Intervention
Standard radiotherapy planning aims to restrict the mean parotid radiation dose to less than or equal to 14 Gy.

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
363 Previous Clinical Trials
91,910 Total Patients Enrolled
Colette Shen, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
1 Previous Clinical Trials
115 Total Patients Enrolled
~65 spots leftby Jul 2028
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