Study on MRI-Guided Radiotherapy Dose Adjustment for HPV-Positive Oropharyngeal Cancer

Program Overview

The aim of this study is to see if using MRI scans to guide the planning of radiation therapy doses can be more effective than the standard approach for patients with low-risk HPV-positive oropharyngeal cancer. MRI scans and radiation therapy are standard methods, but using MRI for dose planning is new. Up to 90 participants will join this study at MD Anderson.

Description

Baseline Visit:

If you qualify and agree to join the study, you'll have a baseline visit where:

• You'll get a hearing test.
• A dental exam will check your saliva flow and for lockjaw.
• Your swallowing will be tested with a special x-ray called a modified barium swallow (MBS).
• You'll fill out a 5-minute questionnaire about swallowing.
• A video-strobe procedure will check your vocal cords using a small camera.
• Photos of your mouth will be taken to check for sores.
• You'll complete questionnaires about your quality of life, work, medical history, smoking, and symptoms, taking about 10-15 minutes.

Study Groups:

• If you're one of the first 15 patients, you'll be in Group 1.
• If you join after the first 15, you'll be randomly assigned to Group 1 or Group 2.
  • Group 1 will use MRI to plan your radiation therapy.
  • Group 2 will receive standard radiation therapy.

Length of Study Participation:

You'll receive radiation therapy for up to 6 ½ weeks. Your participation ends if the cancer worsens, side effects are intolerable, or you can't follow study directions. The study lasts 5 years.

Treatment Planning and Schedule:

You'll have a CT scan for treatment planning and a PET-CT to check the cancer. Group 1 will also have an MRI for planning. All groups receive radiation therapy once a day, Monday to Friday, for up to 33 treatments.

Study Visits:

Every week during radiation therapy:

• Physical exam
• Blood tests
• Questionnaires
• MRI

At Weeks 3 and 6:

• Photos of your mouth
• Dental exam

Group 1 will have MRI simulations at the end of Weeks 1, 2, 3, and 4.

Six weeks after radiation:

• Questionnaires

8-12 weeks after radiation:

• Photos of your mouth
• Hearing test
• MRI for Group 1

6 months, 1 year, and 2 years after radiation:

• Questionnaires
• Mouth exam
• Photos of your mouth
• Video-strobe procedure
• At 1 year: Dental exam and MBS
• At 1 and 2 years: Hearing test

3-6 months, 1 year, and 18-24 months after radiation:

• MBS
• Questionnaires
• Video-strobe procedure

2 years after radiation, if cancer worsens:

• Blood test for tumor cells

5 years after radiation:

• MBS
• Questionnaires

If needed, you may have a tumor biopsy and scans to check the cancer.

Follow-Up Calls:

During the 8-12 weeks after treatment, you'll receive calls or emails every 2 weeks to remind you to fill out a form about side effects, taking about 10-15 minutes each time.

Eligibility Criteria

Locations