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Radiation Therapy

MRI-Guided Radiotherapy for Oropharyngeal Cancer

Phase 2

Waitlist Available

Led By Clifton Fuller, MD, PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Lifetime pack-year history of <10 years, currently non-smoking for at least 5 years

Dispositioned to photon/proton radiotherapy +/- chemotherapy

Must not have

Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease

Having an estimated glomerular filtration rate (GFR) < 40ml/min/1.73m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of treatment up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare different doses of IMRT radiation therapy, using MRI simulations to plan the doses, to the standard IMRT dose in patients with low-risk HPV positive oropharyngeal cancer.

Who is the study for?

This trial is for adults over 18 with HPV-positive oropharyngeal cancer, who haven't had major head and neck surgery or other treatments for it. They should have a light smoking history (less than 10 pack-years) and not currently smoke. Participants need to be in decent health overall, able to understand the study, and women must not be pregnant.

What is being tested?

The study compares MRI-guided IMRT planning with standard IMRT doses in treating low-risk HPV-positive oropharyngeal cancer. The goal is to see if MRI can better tailor radiation doses. All methods are FDA-approved; using MRI this way is investigational.

What are the potential side effects?

Potential side effects include typical reactions from radiotherapy such as skin irritation at the treatment site, fatigue, dry mouth, difficulty swallowing, changes in taste sensation, and possible nausea.

Eligibility Criteria

Inclusion Criteria

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

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I smoked less than 10 pack-years and quit over 5 years ago.

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I am set to receive photon/proton radiotherapy, with or without chemotherapy.

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My cancer is in an early or middle stage and hasn't spread far.

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My cancer is HPV positive.

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I have not had surgery on my head or neck cancer, except for biopsy.

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I can take care of myself and am up and about more than half of my waking hours.

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I have been diagnosed with throat cancer through a biopsy.

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I am 18 years old or older.

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 uncontrolled major health issues.

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My kidney function is reduced with a GFR less than 40.

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I had surgery to remove my head or neck cancer and may have had chemotherapy or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of treatment up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of treatment up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of treatment up to 5 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

Composite Dysphagia Outcome Determined by Diagnosis of Aspiration Pneumonia

Deglutition Disorders

Composite Dysphagia Outcome Determined by Presence of Pharyngoesophageal Structure on Endoscopy with Subsequent Need for Dilation

+3 more

Secondary study objectives

Distant Metastasis-Free Survival

Overall Survival

Personality inventories

+2 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: MRI Guided Intensity Modulated Radiotherapy (IMRT)Experimental Treatment6 Interventions

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Group II: Standard-of-Care Intensity Modulated Radiotherapy (IMRT)Active Control6 Interventions

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy. Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy. IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Symptom Questionnaire

2013

Completed Phase 1

~100

Intensity Modulated Radiotherapy (IMRT)

2011

Completed Phase 2

~300