← Back to Search

Radiation Therapy

MRI-Guided Radiotherapy for Oropharyngeal Cancer

Q: Does the FDA approve of Intensity Modulated Radiotherapy (IMRT) for therapeutic use?

The safety of Intensity Modulated Radiotherapy (IMRT) was rated as a 2 due to the lack of evidence regarding efficacy, despite some clinical data indicating it is safe.

Q: Has recruitment for this research endeavor begun?

The clinical trial is currently in search of participants, as per the records on clinicaltrials.gov. It was initially posted on January 17th 2018 and most recently updated November 17th 2022.

Q: How many participants are currently enrolled in this clinical experiment?

Confirmed. The clinicaltrials.gov page for this medical trial establishes that it is presently recruiting, with the initial posting dating to January 17th 2018 and a recent update on November 17th 2022. This investigation requires seventy-five participants from one site of research.

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of treatment up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Select...

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

Select...

My cancer is HPV positive.

Select...

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

Select...

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

Select...

I have been diagnosed with throat cancer through a biopsy.

Select...

I am 18 years old or older.

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

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

Primary outcome measures

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 outcome measures

Distant Metastasis-Free Survival

Overall Survival

Patient Reported Outcome (PRO) Measures of Symptoms Using FACT-HN

+7 more

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

~110

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,345 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,764 Total Patients Enrolled

Clifton Fuller, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Intensity Modulated Radiotherapy (IMRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03224000 — Phase 2

Oropharyngeal Cancer Research Study Groups: MRI Guided Intensity Modulated Radiotherapy (IMRT), Standard-of-Care Intensity Modulated Radiotherapy (IMRT)

Oropharyngeal Cancer Clinical Trial 2023: Intensity Modulated Radiotherapy (IMRT) Highlights & Side Effects. Trial Name: NCT03224000 — Phase 2

Intensity Modulated Radiotherapy (IMRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03224000 — Phase 2

Frequently Asked Questions

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

Does the FDA approve of Intensity Modulated Radiotherapy (IMRT) for therapeutic use?

"The safety of Intensity Modulated Radiotherapy (IMRT) was rated as a 2 due to the lack of evidence regarding efficacy, despite some clinical data indicating it is safe."

Answered by AI

Has recruitment for this research endeavor begun?

"The clinical trial is currently in search of participants, as per the records on clinicaltrials.gov. It was initially posted on January 17th 2018 and most recently updated November 17th 2022."

Answered by AI

How many participants are currently enrolled in this clinical experiment?

"Confirmed. The clinicaltrials.gov page for this medical trial establishes that it is presently recruiting, with the initial posting dating to January 17th 2018 and a recent update on November 17th 2022. This investigation requires seventy-five participants from one site of research."

Answered by AI

Recent research and studies

Clinical and Translational Radiation OncologyJournal

Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx Treated with Radiotherapy (MR-ADAPTOR): An R-IDEAL Stage 2a-2b/bayesian Phase II Trial

Bahig, Houda, Ying Yuan, Abdallah S.R. Mohamed, Kristy K. Brock, Sweet Ping Ng, Jihong Wang, Yao Ding, et al.. 2018. “Magnetic Resonance-based Response Assessment and Dose Adaptation in Human Papilloma Virus Positive Tumors of the Oropharynx Treated with Radiotherapy (MR-ADAPTOR): An R-IDEAL Stage 2a-2b/bayesian Phase II Trial”. Clinical and Translational Radiation Oncology. Elsevier BV. doi:10.1016/j.ctro.2018.08.003.

clinicaltrials.govStudy

Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

2018. "Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03224000.